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Asia Pac J Clin Nutr 2017;26(6):1055-1065 1055
Original Article
Portion controlled ready-to-eat meal replacement is
associated with short term weight loss: a randomised
controlled trial
Rebecca Kuriyan PhD1, Deepa P Lokesh MSc1, Ninoshka D’Souza MSc1,
Divya J Priscilla BSc1, Chandni Halcyon Peris MSc1, Sumithra Selvam MSc2,
Anura V Kurpad MD, PhD1
1Division of Nutrition, St John’s Research Institute, St John’s National Academy of Health Sciences,
Bangalore, India
2Division of Epidemiology and Biostatistics, St John’s Research Institute, St John’s National Academy of
Health Sciences, Bangalore, India
Background and Objectives: Strategies to prevent and treat overweight/obesity are urgently needed. This study
assessed the effect of a short-term intake of ready-to-eat cereal on body weight and waist circumference of over-
weight/obese individuals in comparison to a control group. Methods and Study Design: A randomized, con-
trolled 2-arm trial was carried out on 101 overweight/obese (Body Mass Index – 29.2±2.4 kg/m2) females aged 18
to 44 years, at St. John’s Medical College Hospital. The intervention group received a low fat, ready to eat cereal,
replacing two meals/day for two weeks. The control group was provided with standard dietary guidelines for
weight loss and energy requirements for both groups were calculated similarly. Anthropometric, dietary, appetite
and health status assessments were carried out at baseline and at the end of two weeks. Results: At the end of two
weeks, the mean reductions in body weight and waist circumference were significantly greater in the intervention
group, -0.53 kg; 95% CI (-0.86 to -0.19) for body weight and -1.39 cm; 95% CI (-1.78, -0.99) for waist circum-
ference. The intervention group had a significantly higher increase in dietary intakes of certain vitamins, fiber
and sugar, and significantly higher reductions in total and polyunsaturated fats and sodium intakes, as compared
to the control group (p≤0.05). No significant differences were observed between the groups, in change of appetite,
health and perception scales. Conclusions: Portion controlled, ready to eat cereal could be effective for short-
term weight loss, with some improvements in the nutrient intake profile. However, studies of longer duration are
needed.
Key Words: weight loss, meal replacement, portion control, ready to eat cereal, Indian women
INTRODUCTION
Overweight and obesity have become global epidemics,
affecting both developed and developing countries. The
co-morbidities associated with these conditions create a
profound health burden.1 While their causes are multifac-
torial, the most evident contributing factors of overweight
and obesity are an increased intake of energy-dense foods,
sedentary lifestyle and a lack of physical activity.2 Asians
have higher risks of obesity related co-morbidities com-
pared with their white European counterparts, and this
occurs at a lower body mass index (BMI).3,4 In India,
overweight and obesity rates are 3 times higher in urban
than rural areas and are more common among women.5
About 24% of women in urban areas are overweight or
obese and these rates increase with advancing age and
higher incomes.5 India has a dual burden of diseases with
increasing prevalence of overweight and obesity existing
along with persisting rates of under-nutrition and micro-
nutrient deficiency, with 36% of the women being un-
derweight and having micro-nutrient deficiency.5 Thus,
strategies which can be used to prevent/treat weight gain
and improve the micro-nutrient status are warranted in
India.
The optimal management of overweight and obesity
requires a combination of diet, exercise, and behavioral
modification. Potential weight reduction diets include
low calorie, low fat, low carbohydrate, low glycemic in-
dex, high protein or high fibre and these diets have shown
to effectively reduce body weight, with improvements in
diabetes and cardio-vascular risk factors.6 The principal
of energy balance, however, still remains the cornerstone
of weight control.
Portion controlled meal replacement programs are
Corresponding Author: Dr Rebecca Kuriyan, Division of Nu-
trition, St John’s Research Institute, St John’s National Acade-
my of Health Sciences, Bangalore – 560034. India.
Tel: 91-80-49467000; Fax: 91-80-49467000
Email: rebecca@sjri.res.in
Manuscript received 11 May 2016. Initial review completed 24
June 2016. Revision accepted 26 July 2016.
doi: 10.6133/apjcn.022017.07
1056 R Kuriyan, DP Lokesh, N D’Souza, DJ Priscilla, CH Peris, S Selvam and AV Kurpad
popular dietary interventions designed to replace higher
calorie meals and include beverages, frozen entrees,
breakfast cereals, and meal/snack bars.7 Meal replace-
ment diet plans offer a viable strategy for controlling
weight, positively impacting health outcomes,8 with re-
sults of greater weight loss,7 adequate intake of essential
nutrients9,10 and long-term maintenance of weight loss.10
Participants consuming meal replacements reported better
dietary compliance and convenience, when compared to
conventional weight-loss programs.11 Ready to eat cereals
have been used successfully for weight loss12-14 and their
effectiveness has been attributed to their palatability,
which is resistant to hedonic shifts, and increased ac-
ceptance, since it is a dietary staple.12 A recent review15
summarized that ready to eat breakfast cereals are rela-
tively inexpensive, nutrient-dense and convenient foods,
which when consumed regularly may ensure adequate
nutrient intake and help in reducing the risks of being
overweight or of developing cardiovascular disease or
diabetes.
In spite of excessive dietary consumption, over-
weight/obese individuals could have micronutrient defi-
ciencies.16 Portion controlled, fortified ready to eat cere-
als could provide an effective way for reduc-
ing/maintaining weight, with beneficial effects on the
micro-nutrient status. A well-controlled study conducted
in India, where the socio-cultural and economic impera-
tives are different from affluent countries, could provide
new insights on the prevention/management of weight
gain.
The objectives of the present study were to primarily
assess the change in body weight and waist circumference
of overweight/obese individuals who consumed a low fat
ready-to-eat cereal for two weeks, in comparison to a
control group provided with standard dietary guidelines,
and secondarily, to assess the change in dietary, appetite,
and health status.
METHODS
The study was conducted in the Nutrition & Lifestyle
Clinic of St John’s Medical College Hospital, India, from
August 2014 to February 2015. The subjects were re-
cruited by posted flyers and through word of mouth. The
inclusion criteria were normal, healthy, premenopausal
women with a BMI of 25 to 34.9 kg/m2, and an age range
of 18 to 44 years. The subjects were mainly administra-
tive staff, nurses and doctors. The exclusion criteria were
any history of surgical intervention for the treatment of
obesity, weight loss or gain greater than 4.5 kg in the two
months prior to visit, use of any medications that could
affect weight, history or presence of any clinically signif-
icant medical conditions such as diabetes, polycystic ova-
ry syndrome, thyroid disease, cardiac, renal or hepatic
disorders. A sample size of 42 subjects per group was
considered adequate to detect a difference in weight loss
of 1.3 kg between the intervention and control groups,
assuming a pooled standard deviation of 1.6 kg with a
two-tailed alpha of 0.05 and 90% power. The study was
approved by the Institutional Ethical Review Board (IEC
Study Ref No. 52/2014) of St. John’s Medical College,
Bangalore. Informed consent was obtained from all the
participants.
Study design
The study was a randomised, controlled, open label trial
with two groups. After recruitment, the subjects were
randomised into either a low fat cereal group (Interven-
tion group) or the usual care group (Control group), using
simple randomisation. An online random sequence gener-
ator was used by the statistician, to generate a digit se-
quence containing 1 s and 2 s (50 each) in random order
that was kept in a folder in the co-investigators office.
Group assignment was performed by a staff member re-
ferring to the sequence and assigning the participant to
the group represented by the next digit in the sequence.
The sheet was kept safely in the custody of the co-
investigator. None of the study staff, except the nutrition-
ist who planned the diet and served the breakfast, were
aware of the group to which the participants were as-
signed. The participants were not blinded to the interven-
tion. The study has been registered under the Clinical
Trials Registry of India (Clinical Trial Registry - India -
Ref No: Ref/2014/11/007883).
Intervention
The intervention was a fixed energy (250 kcal per meal)
control program with dietary energy allocated for two
meals (breakfast and another meal of the day), for a dura-
tion of two weeks. Each time, the intake of a sachet of 30
g of low fat cereal (ingredient and nutrition information
are provided in Table 1) was advised, with 120 mL skim
milk and a serving of fruit or vegetables. Subjects were
instructed not to consume any additional food for break-
fast or for the second meal eaten at lunch or dinner. The
third meal was recommended as a normal meal (the meal
that they routinely ate). Individualized dietary advice was
provided to all the subjects, with options for snacks and
the third meal. The subjects were provided with a week’s
supply of the intervention product and were asked to
bring back the empty sachets during their visits. They
were also asked to fill in a compliance log to record the
consumption of the intervention product and were asked
to register if they consumed/did not consume the inter-
vention at breakfast, lunch or dinner.
Control group
The control group was only prescribed dietary advice,
along with a diet sheet/ handout with recommendations
for portion sizes and exchanges for the whole day. No
meals were provided to the control group.
The energy requirement for the subjects of both the in-
tervention and control groups were calculated based on
BMI, ideal body weight (IBW) and activity levels. 1 7
About 25 kcal/kg IBW was prescribed for overweight
subjects, while obese subjects were prescribed energy at
22 kcal/kg IBW. The macronutrient distribution was 60-
65% of total energy for carbohydrates, 12-15% for pro-
tein and 20-25% of fat. All the participants received a
handout which provided an individualized diet plan. The
energy requirements for the day were divided into three
meals and two snacks. Dietary advice on portion size,
meal frequency, food exchanges and recommended foods
were also provided to the patients as per these guide-
lines,17 in order to translate the macronutrient advice to
food. Trained nutritionists advised the individuals on
Ready-to-eat cereal and short term weight loss 1057
their food intake.
Anthropometry
Fasting body weight was recorded using a calibrated digi-
tal weight scale (Salter, Germany) to the nearest 0.1 kg.
Height was measured to the nearest 0.1 cm using a mobile
stadiometer (Seca 213, USA). BMI was calculated as
Weight (kg)/Height (m2). Waist circumference, ab-
dominal waist and hip circumference were measured us-
ing a non-stretchable tape (ADC396, USA) using stand-
ard procedures.18 Waist circumference was measured at
the narrowest part between the last rib and the iliac crest.
Abdominal waist circumference was measured at the lev-
el of the greatest anterior extension of the abdomen in a
horizontal plane (usually at the level of the umbilicus),
between the last rib & the iliac crest, while hip circumfer-
ence was measured with the tape placed around the but-
tocks in a horizontal plane at the level of maximum ex-
tension of the buttocks.18 All the measurements were
measured thrice to the nearest 0.1 cm and the mean of the
three readings was taken. These measurements were car-
ried out on Days 1 and 14 by trained nutritionists. Meas-
urements on each subject on different visits were done by
the same examiner to reduce variability. The within and
between measurer coefficient of variation (CV) was 0.2%
and 0.3% respectively.
Dietary intake
The dietary intake of each subject was assessed using a 3-
day food record method on two occasions (before the start
of study and end of study) and included two weekdays
and a weekend day. The subjects were trained on how to
record their intake. The training of participants on re-
cording their dietary intake was performed by a nutrition-
ist, while another nutritionist analysed the dietary records.
Energy and nutrient intake was computed using a nutrient
database for Indian foods19 and from the United States
Department of Agriculture, USDA.20
Visual analogue scale
Four 100 mm visual analogue scales (VAS)21 were used
to assess satiety on days 1 and 14. The four variables
were hunger, fullness, urge to eat and thoughts of food.
Subjects were requested to make a vertical mark on each
line that best matched how they were feeling at the time.
Each score was determined by measuring the distance
from the left side of the line to the mark. The VAS was
first administered in the fasted state. The subjects were
then provided breakfast at the study site, under the super-
vision of the study staff. The intervention group received
the product, while the control group was provided with a
breakfast (south Indian idli with chutney) which was
equal in calories (250 kcals) to the intervention product.
The VAS scale was administered again after breakfast.
Each time, the VAS was administered in triplicate, and
the scores were calculated from the mean of the three
readings for both time points (pre- breakfast and post
breakfast).
Questionnaires
Health status (SF-36)22 and physical activity23 question-
naires were administered on days 1 and 14, perception
and program acceptability questionnaires were adminis-
tered on day 14, and compliance to dietary intervention
was administered on days 7 and 14. The perceived com-
pliance of the subjects to the prescribed dietary advice
Table
1
Nutrient and ingredient information of the intervention
Nutrition and ingredient information
†
Typical value for 30 g 30 g serving with
120 mL of skim milk‡ (% RDA)§
Energy 109 kcal 144 kcal
Energy from fat 3 kcal 4 kcal
Total fat 0.3 g 0.4 g
Saturated fatty acids 0.1 g 0.2 g
Monounsaturated fatty acids 0.1 g 0.1 g
Polyunsaturated fatty acids 0.1 g 0.1 g
Trans fatty acids 0.0 g 0.0 g
Cholesterol 0.0 mg 0.0 mg
Total carbohydrates 25.6 g 31.1 g
of which sugar (Sucrose) 7.5 g 7.5 g
Dietary fibre 1.5 g 1.5 g
Protein 2.5 g 5.5 g
Sodium 0.20 g 0.25 g
Vitamin A 30.0 µg 35.4 µg 6
Vitamin C 9.9 mg 11.1 mg 28
Thiamine (Vit B-1) 0.3 mg 0.3 mg 30
Riboflavin (Vit B-2) 0.3 mg 0.3 mg 32
Niacin (Vit B-3) 4.1 mg 4.2 mg 35
Vitamin B-6 0.5 mg 0.5 mg 25
Vitamin B-12 0.1 µg 0.7 µg 68
Folate 25.2 µg 25.2 µg 13
†Ingredients: rice (36.15 %), whole wheat (33.24 %), sugar, wheat bran (4.74 %), liquid glucose, iodised salt, malt extract, vitamins, min-
erals and antioxidant (INS320). Contains gluten, may contain traces of almond (tree-nut).
‡If cereal is had with cow’s milk, the energy value will increase b y 46 kcals and the fat by 4.8 g.
§RDA, Recommended Dietary Allowance. RDA per day for sedentary women basis. Nutrient Requirements and RDA for Indians by
ICMR, 2010.
1058 R Kuriyan, DP Lokesh, N D’Souza, DJ Priscilla, CH Peris, S Selvam and AV Kurpad
was recorded at the end of two weeks, by asking the sub-
jects to orally express their level of compliance on a scale
of 0-100%.
Statistical Methods
Assumption of normality was assessed using a Q-Q plot.
The data were presented as mean ± standard deviation for
normally distributed continuous variables. The primary
outcome of the study was the change in weight and waist
circumferences from baseline. The analyses for the pri-
mary objective was carried out using both per protocol
(PP) and “Intention to Treat” (ITT) principle. In the ITT
analysis, all subjects randomized into the study, were
considered for statistical analyses. For the 9 subjects who
dropped out for the end measurement, the baseline obser-
vation carried forward approach was used. The change
(difference) in each parameter was computed between
two time points (Day 14- Day 1) for all the parameters.
Baseline characteristics were compared between the study
groups using an independent t test. The independent ‘t’
test was used to compare the change in anthropometric
characteristics between the study groups for both PP and
ITT analysis. The change in the secondary outcomes of
VAS parameters, which were not normally distributed,
were analyzed using the Mann Whitney U test. Within
group comparison was carried out using paired t test
analysis. In addition, anthropometric parameters were
analyzed using analysis of covariance (ANCOVA) to
assess the effect of intervention at endline and adjusting
for baseline measurements as a covariate. Dietary intake
parameters were analyzed between groups using the
Mann Whitney U test. Additionally, for dietary intake
parameters that were significantly different at the baseline
(vitamin A, sugar and protein) between the study groups,
ANCOVA was carried out, adjusting for baseline values.
All analyses were carried out using SPSS version 22 and
the significance level was set at p≤0.05 (two-sided).
RESULTS
The flowchart of the subjects is provided in Figure 1. A
total of 110 subjects were recruited. The mean age of the
subjects was 30.9±6.4 years, with no significant differ-
ence between the two groups. The monthly income and
educational status were comparable between the groups.
The mean weight, BMI, waist circumference, abdominal
waist circumference and hip circumference of the subjects
were 70.8±7.4 kg, 29.2±2.4 kg/m2, 84.8±6.1 cm, 95.3±7.0
cm and 105.9±6.3 cm respectively. There were no signif-
icant differences in the anthropometric parameters be-
tween the two groups at the baseline. The demographic
characteristics of the non-responders (loss to follow up)
were comparable to the responders of the study.
Figure 2 depicts the comparison of pre – post differ-
ence in measures between the study groups for body
weight, waist and hip circumferences.
Table 2 depicts the baseline parameters of the two
groups and there were no significant differences between
the study groups. The mean change (ITT analysis) in
body weight, waist circumference, abdominal waist and
hip circumferences from Day 1 to Day 14 were signifi-
Figure 1. Participant flow diagram.
Ready-to-eat cereal and short term weight loss 1059
cantly higher in the intervention group as compared with
the control (p<0.01) (Table 3). The results of the PP anal-
ysis were similar and the mean change was significantly
higher in the intervention group as compared with the
control group (p<0.01). The ANCOVA results (not de-
picted) also showed that the body weight, waist circum-
ference, abdominal waist and hip circumferences were
significantly different between the groups at the end of
the study, after adjusting for baseline values. For analyses
performed within each study group, significant reductions
were observed in both groups from day 1 to day 14 for all
anthropometric parameters (p<0.001), although the reduc-
tions were significantly greater in the intervention group
(p<0.01). The effect size for Body weight and BMI was
0.3 for both PP and ITT analysis, while waist circumfer-
ence, abdominal waist and hip circumference was 0.5 for
PP analysis and 0.6 for ITT analysis.
The mean change in appetite assessment parameters
were not significantly different between groups (Table 4).
In both groups, paired analysis of the mean change at the
end of the study showed significant reductions in the
thoughts of food, urge to eat and hunger, with significant
increases in the feeling of fullness (p<0.001; data not
shown).
The dietary analysis data showed that, when compared
to the control group, the reductions in intakes of total fat,
polyunsaturated fatty acid (PUFA) and sodium, along
with the increases in the intakes of niacin, vitamin B-6,
B-12, fiber and sugar were significantly greater in the
intervention group (p<0.01). The dietary intake of vitamin
B-6 in the intervention group increased by 20% (from an
intake of 65% of daily recommended value24 to 85%)
from Day 1 to Day 14, while in the control group, it de-
creased by 15% (from an intake of 70% of daily recom-
mended value to 55%). Similarly, dietary fiber increased
by 3% (from an intake of 22% to 25% of daily recom-
mended value) in the intervention group, while it d e-
creased by 1.4% (from an intake of 21% to 19.6 % of
daily recommended value) in the control group. The die-
tary intakes of niacin and vitamin B-12 of both the groups
met the recommended intakes on Day 1 and further in-
creased in the intervention group, but decreased in the
control group on Day 14 (Table 5). Conversely, total die-
tary fat intake reduced from 27.5% of total energy to
20.5% in the intervention group, while in the control
group it decreased from 27.5% total energy to 25.2%.
PUFA levels decreased by 3% (from 10% to 7% of total
energy) in the intervention group. Sodium intake in the
intervention group was 126% of the recommended intake
(1.9 g/day) on Day 1, but reduced to 63% of the recom-
mended intake on Day 14, while in the control group the
sodium intake did not decrease to the level of recom-
mended intake. These results are depicted in Table 5.
The results of ANCOVA analysis (data not shown) had
Figure 2. Comparison of pre – post difference in measures between the study groups for body weight, waist and hip (Intention to Treat –
ITT analysis). (a) Pre-post difference in body weight between the two groups; (b) Pre-post difference in wa ist circumference between the
two groups; (c) Pre-post difference in hip circumference between the two groups. N=56 (Intervention Group) and N=54 (Control Group).
Table 2. Baseline parameters of the study groups
Parameter Overall
(N=101)
Intervention group
( N=51)
Control group
(N=50) p value§
Age (yrs) 31.0±6.5 30.5±6.3 31.6±6.6 0.38
Weight (kg) 70.8±7.4 70.6±7.9 71.1±7.0 0.76
BMI (kg/m
2
) 29.2±2.4 29.0±2.3 29.3±2.5 0.54
Waist circumference (cm)
‡
84.8±6.1 85.3±5.4 84.3±6.8 0.40
Abdominal waist circumference (cm)
‡
95.3±6.9 95.3±6.8 95.3±7.3 0.98
Hip circumference (cm)
‡
105.9±6.3 104.9±6.4 107.0±6.0 0.09
Physical activity level
‡
1.59±0.16 1.61±0.16 1.57±0.15 0.17
BMI: body mass index.
†All values are Mean±SD.
‡Waist circumference was measured at the narrowest part between the last rib & the iliac crest; abdominal waist circumference was meas-
ured at the level of the greatest anterior extension of the abdomen in a horizontal plane (usually at the level of the umbilicus), between the
last rib & the iliac crest; hip circumference was measured with the tape placed around the buttocks in a horizontal plane at the level of
maximum extension of the buttocks.18 Physical activity level was assessed using a validated questionnaire.23
§p value - Values were analyzed between study groups using independ ent t test
1060 R Kuriyan, DP Lokesh, N D’Souza, DJ Priscilla, CH Peris, S Selvam and AV Kurpad
similar statistical significance. Thiamine and Vitamin A
intakes did not show any significant differences for both
groups at the end of the study, compared with the baseline.
There were no significant changes observed in the
health and perception assessment parameters between the
groups at the end of the study. The self-reported compli-
ance of the subjects to the prescribed dietary advice was
significantly higher in the intervention group compared
with the control group (90.1% vs 81.5%; p<0.01) at the
end of the study. There were no changes in the physical
activity levels in either group from day 1 to day 14.
T
able 3
.
Comparison of anthropometric parameters between study groups
–
Intention to Treat (ITT) analysis
Parameter Intervention group
(N=56)
Control group
(N=54) p value§
Weight (kg) Day 1 70.4±8.1 70.8±7.8 0.75
Day 14 69.2±8.1 70.2±7.8 0.53
Change -1.2±0.9 -0.7±0.8 <0.01
*
BMI (kg/m
2
) Day 1 29.0±2.3 29.2±2.7 0.66
Day 14 28.5±2.4 28.9±2.7 0.39
Change -0.5±0.4 -0.3±0.3 <0.01
*
Waist circumference (cm)
‡
Day 1 84.9±5.9 84.5±7.3 0.77
Day 14 82.6±5.7 83.5±7.3 0.45
Change -2.3±1.2 -1.0±0.9 <0.001
*
Abdominal waist circumference (cm)
‡
Day 1 94.9±7.5 95.7±7.5 0.58
Day 14 92.7±7.5 94.9±7.5 0.13
Change -2.2±1.3 -0.8±0.8 <0.001
*
Hip circumference (cm)
‡
Day 1 105.0±6.8 106.8±6.1 0.16
Day 14 103.9±6.8 106.4±6.1 <0.05
*
Change -1.1±0.8 -0.4±0.4 <0.001
*
BMI: body mass index.
†All values are Mean±SD.
‡Waist circumference was measured at the narrowest part between the last rib & the iliac crest; abdominal waist circumference was
measured at the level of the greatest anterior extension of the abdomen in a horizontal plane (usually at the level of the umbilicus), be-
tween the last rib & the iliac crest; hip circumference was measured with the tape placed around the buttocks in a horizontal plane at the
level of maximum extension of the buttocks.18
§p value - Day1, Day 14 and change in values were analyzed between study groups using independent t test.
Table 4. Comparison of Visual Analogue Scale parameters on Day 1, for pre and post breakfast between study groups
Parameter Intervention
(N=51)
Control
(N=50)
p value§
Day 1 - Thoughts of food Pre breakfast 30.8±23.7 25.7±17.1
0.48
Post breakfast 16.3±15.5 12.7±13.9
0.33
Change -14.4±18.6 -13.0±19.7
0.97
Day 1 - Urge to eat Pre breakfast 31.2±25.0 26.0±14.5
0.71
Post breakfast 14.0±16.3 10.1±10.6
0.35
Change -17.1±21.4 -15.9±13.7
0.60
Day 1 - Hunger Pre breakfast 32.0±23.8 33.4±18.5
0.39
Post breakfast 15.4±17.3 13.3±16.4
0.46
Change -16.6±19.3 -20.1±21.0
0.22
Day 1 - Feeling of fullness Pre breakfast 21.5±20.0 34.5±25.9
<0.01
*
Post breakfast 71.5±26.2 81.1±20.8
0.12
Change 50.0±29.9 46.6±27.8
0.74
Day 14 - Thoughts of food Pre breakfast 30.2±27.5 26.0± 18.5
0.94
Post breakfast 13.0±13.0 9.9±11.2
0.27
Change -17.2±25.8 -16.1±18.2
0.43
Day 14 - Urge to eat Pre breakfast 34.1±28.6 31.1±19.1
0.99
Post breakfast 13.0±13.8 7.7±8.2
0.08
Change -21.1±25.2 -23.3±18.5
0.28
Day 14 - Hunger Pre breakfast 33.0±26.2 33.6±21.9
0.70
Post breakfast 13.0±13.0 10.6±12.6
0.25
Change -20.1±24.3 -23.1±19.8
0.25
Day 14 - Feeling of fullness
Pre breakfast 28.9±25.5 34.1±23.6
0.21
Post breakfast 77.0±21.7 82.1±19.2
0.35
Change 48.1±34.3 48.0±25.3
0.99
†All values are mean±SD.
‡Change calculated as Post Breakfast- Pre Breakfast.
§p value – Pre, Post and Change in values were analyzed between study groups using Mann Whitney U test.
Ready-to-eat cereal and short term weight loss 1061
Table
5
.
Comparison of average dietary intake of the study subjects betwe
en study groups
Parameter Intervention (N=51) Control (N=50)
p
value
§
Energy (kcals) Day 1 1548.4±465.8 1587.0±447.5 0.67
Day 14 1074.7±260.7 1145.6±207.3 0.14
Change -470.4±408.4 -433.8±433.8 0.47
Protein (g) Day 1 49.8±14.8 55.4±18.6 0.09
Protein (% Energy) 13.0±2.2 13.9±2.5 0.05
Protein (g) Day 14 38.0±9.5 37.6±8.8 0.85
Protein (% Energy) 14.2± 1.8 13.2±2.6 0.71
Change(g) -11.6±13.0 -17.3±19.4 0.19
Fat (g) Day 1 48.8±21.7 49.3±18.2 0.89
Fat (% Energy) 27.5±5.8 27.5±4.4 0.99
Fat (g) Day 14 25.4±10.9 32.3±9.1 <0.01
*
Fat (% Energy) 20.5±4.7 25.2±4.4 <0.01
*
Change (g) -23.1±18.8 -16.7±17.3 0.05
*
Carbohydrate (g) Day 1 228.6±64.4 231.6±63.0 0.81
Carbohydrate (% Energy) 59.7±5.9 58.8±5.6 0.43
Carbohydrate (g) Day 14 176.7±37.1 176.8±33.7 0.98
Carbohydrate (% Energy) 65.8±5.1 61.9±5.7 0.80
Change(g) -51.9±59.9 -54.0±61.7 0.97
Fiber intake (g) Day 1 6.7±2.9 6.3±2.7 0.55
Day 14 7.5±2.3 5.9±2.4 <0.01
*
Change 1.0±3.0 -0.5±4.0 0.03
*
Saturated fat (g) Day 1 16.9±9.1 18.1±8.4 0.51
Day 14 8.3±4.2 10.9±4.1 <0.01
*
Change -8.5±7.7 -7.1±8.3 0.33
Monounsaturated fat (g) Day 1 10.9±5.1 11.3±4.9 0.69
Day 14 5.8±2.7 7.3±2.4 <0.01*
Change -5.1±4.7 -3.9±4.9 0.07
Polyunsaturated fat (g) Day 1 17.2±8.1 16.3±5.9 0.50
Day 14 8.4±4.7 11.8±4.0 <0.001
*
Change -8.7±7.4 -4.4±6.0 <0.01
*
Cholesterol (mg) Day 1 114.2±99.5 128.6±87.5 0.44
Day 14 49.5±37.3 69.9±51.6 <0.05
*
Change -64.2±93.1 -55.0±82.8 0.53
Vitamin A (mcg) Day 1 337.3±229.2 263.8±108.5 <0.05
*
Day 14 313.5±158.3 254.3±124.1 <0.05
*
Change -25.3±228.1 -4.2±144.6 0.68
Thiamin (mg) Day 1 1.4±2.2 1.1±1.1 0.49
Day 14 1.1±0.2 0.84±0.2 <0.001
*
Change -0.3±2.3 -0.3±1.2 0.006
Riboflavin (mg) Day 1 0.9±0.4 0.9±0.3 0.89
Day 14 0.8±0.2 0.7±0.2 <0.05
*
Change -0.1±0.4 -0.2±0.3 0.05
*
Niacin (mg) Day 1 13.0±4.4 14.1±5.2 0.26
Day 14 14.8±2.8 9.4±3.0 <0.001
*
Change 1.8±4.2 -4.7±6.0 <0.001
*
Vitamin C (mg) Day 1 72.5±44.6 64.7±80.5 0.55
Day 14 95.2±61.7 68.6±70.6 0.05
Change 23.5±68.6 3.2±106.7 0.39
Vitamin B-6 (mg) Day 1 1.3±0.5 1.4±0.5 0.40
Day 14 1.7±0.3 1.1±0.3 <0.001
*
Change 0.4±0.5 -0.3±0.5 <0.001
*
Folate (mcg)
Day 1 202.2±85.9 195.1±105.4 0.71
Day 14 153.4±49.5 149.0±40.8 0.64
Change -43.1±77.3 -43.6±117.5 0.43
Vitamin B-12
(mcg)
Day 1 1.3±1.3 1.6±1.5 0.24
Day 14 2.1±0.8 0.9±0.8 <0.001
*
Change 0.9±1.4 -0.63±1.6 <0.001
*
Sugar (g) Day 1 18.9±11.8 23.6±15.5 0.09
Day 14 28.5±10.4 14.6±8.5 <0.001
*
Change 9.6±10.2 9.0±15.8 <0.001
*
Sodium (g) Day 1 2.4±1.0 2.4±1.0 0.92
Day 14 1.2±0.6 2.0±0.6 <0.001
*
Change -1.2±1.0 -0.5±0.8 <0.001
*
†All values are mean±SD
‡Day 1values refer to 3 day food recall before the start of the study; Day 14 values refer to 3 day food recall at the end of the two weeks.
“Change” was calculated as Day 14 – Day 1
§p value – Day1, Day 14 and Change in values were analyzed between study groups using Mann Whitney U test.
¶All values were calculated from our database using recipes which used values obtained from both NIN & USDA.19,20
1062 R Kuriyan, DP Lokesh, N D’Souza, DJ Priscilla, CH Peris, S Selvam and AV Kurpad
DISCUSSION
Portion-controlled meal replacements, included as part of
a structured meal plan, have been shown to be a safe and
effective method for increasing dietary compliance and
providing clinically meaningful and sustainable weight
loss and improvements in weight-related disease risk fac-
tors.8,25,26 The present study showed that significantly
greater reductions were observed in body weight and
waist circumference of overweight and obese individuals,
consuming a portion controlled low fat ready-to-eat cereal
for two weeks, when compared with the control group.
Additional beneficial changes in the intervention group
included a significantly lower dietary intake of total fat,
polyunsaturated fats and sodium. The intervention group
had higher intakes of niacin, vitamin B-6, B-12 and fiber
at the end of the two week program. The reduction in
body weight and waist circumference observed in the
present study was similar to previous studies conducted in
other populations.12,15,27
The rapid initial weight loss observed within the first
week of weight reducing programs are thought to be due
to the diuresis associated with loss of glycogen stores.28,29
The amount of glycogen in skeletal muscle is about 400-
500 g, while about 70-100 g is stored in the liver.30 When
glycogen stores are completely depleted, along with the
loss of associated water (1 g of glycogen carries 3 g of
water with it), then the expected weight loss would be
about 1-1.5 kg. The observed weight loss of the present
study was within this range, however the intervention in
the present study would not have completely depleted the
entire glycogen stores, since the carbohydrate intake of
the subjects of the intervention group was high -176 g/day
(~65% of the total energy) at Day 14. It is not possible
to estimate the proportion of fat loss in the body weight
loss, however, one can surmise that since the waist cir-
cumference of the intervention group decreased by 2.3 cm,
compared with 1cm in the control group, it is reasonable
to assume that this would be abdominal fat loss. A recent
study with an adult intervention of a ready to eat cereal,
as part of meal replacement plan for two weeks reported a
significant reduction of 1.6 (1.4) kg in body weight, of
which a significant 0.7 (0.8) kg reduction in body fat
mass (measured by Dual energy X-ray absorptiometry)
also occurred.31 This indicates that in this paradigm of
rapid weight loss, about 50% of the weight lost was body
fat.
The two week intervention period of the present study
assessed only short-term weight loss. As such, short term
meal replacement plans (for ~14 days) have been used
previously as motivation tools to encourage long term
dietary change, and have reported about 2 kg reductions
in body weight in otherwise healthy overweight and
obese individuals.12,13,27 That this weight loss is sustained,
is demonstrated from the observation that initial weight
loss (percentage weight loss after one month) was ob-
served to be one of the strongest predictors of long term
weight loss success, in a weight reduction programme.32
The reason for the sustained weight loss could be due to
an improvement in quality of life factors such as general
appearance, body image, physical mobility, energy and
perceived health during the first four weeks of a weight
control program, which have been associated with greater
weight reductions at end of treatment. Positive quality of
life changes may serve as re-inforcers, increasing healthy
behaviors and healthy habit learning, leading to success-
ful weight loss and maintenance.33 Equally, failures of
weight loss programs are also common, and while short
term interventions for initial weight loss can be useful as
an effective motivator, continued interventions for a
longer duration of time are needed to sustain the weight
loss/weight management.
The participants in the intervention group showed some
ancillary beneficial effects in the dietary intake, with a
decrease in dietary fat and sodium intake, while the intake
of fiber and vitamins such as niacin, vitamin B-6, and B-
12 significantly increased at the end of two weeks, when
compared to the control group. The low fat ready to eat
cereal was fortified with B vitamins and enriched with
whole grains which increased the fiber content, and
helped in improving the diet quality, even while on a re-
duced energy diet. Since biomarker levels were not meas-
ured in this study due to budgetary constraints, future
studies need to confirm these beneficial findings by esti-
mating biomarker levels. The fat intake of the interven-
tion group decreased significantly by 47% at the end of
the study compared with the baseline, which was similar
to earlier reports in meal replacement programs.9,10 Partial
meal replacement plans, especially ready to eat cereals,
have been earlier associated with higher micronutrient
intake when compared with controls,9,16,34,35 suggesting
that these plans could help in assisting weight loss along
with improvement in the quality of the diet. The interven-
tion of (cereal+ milk) together in the present study pro-
vided 7.5 g total sugar per serving of 30 g (25% sugar by
weight). Converse to these beneficial changes in the diet,
the intake of free sugar in the intervention group in-
creased from 5% of total energy intake on Day 1 to ~10%
on Day 14. However, this increase was within the upper
limit (5-10% of total energy intake) set by the WHO36 for
the intake of free sugars. Data are not available from pre-
vious studies on the magnitude of change in the dietary
sugar intake, following the consumption of ready to eat
cereals, but in the light of new recommendations on re-
stricting free sugar intake,36 attention should also be given
to this aspect of the diet. It is worth noting that significant
weight loss and reductions in waist circumference were
observed in the intervention group, in spite of the signifi-
cant increase in dietary sugar intake. Possible reasons
include the significant decrease in total energy intake and
dietary fat. Existing evidence supporting a link between
total sugar intake and obesity is lacking or weak and it
has been suggested that advice relating to sugar in the
context of weight management should be directed at en-
suring adequate nutrient intakes.37 Thus, the small but
significant increase in sugar intake of the intervention
group (from day 1 to day 14) compared with the control
group, did not have an effect on the weight loss results.
Participants consuming meal replacements have previ-
ously reported greater compliance and convenience com-
pared to those in a conventional weight-loss program,11
which are characteristics that could enhance adherence. In
the present study, the compliance (self-reported) of the
intervention group to the prescribed dietary advice was
significantly higher than the control group, suggesting
Ready-to-eat cereal and short term weight loss 1063
that the ready-to-eat portion controlled cereal intervention
could have augmented greater compliance to the diet and
dietary advice provided, resulting in subsequent weight
loss. An additional plausible behavioral mechanism that
has been postulated, is that the amount of food offered as
a meal replacement may be accepted by the individual as
the ‘‘norm’’ for the meal, and they then may not compen-
sate, i.e. eat extra at the next meal, thus leading to an en-
ergy deficit.38
To our knowledge, this is the first study in which sub-
jects of both an intervention and control group were pre-
scribed similar daily energy intakes, and is therefore nov-
el, as the increased weight loss in the intervention group
occurred within a rigorously conducted intervention trial
format. The present study also demonstrated reductions in
waist and hip circumferences about 2.5 and 3 times great-
er, respectively, in the intervention group compared with
the control group, in spite of similar energy intakes. The
observed beneficial effects on body weight and circum-
ferences were not likely to be due to differences or
changes in physical activity, since the physical activity of
both the groups were not significantly different at the start
of the program and all study participants were advised to
continue with their existing physical activity patterns for
the two week duration.
The cause for the increased weight loss is likely to be
multifactorial, as discussed below. The energy intake of
subjects in both the groups decreased progressively by
approximately 400 kcal/day (470 in intervention group
and 434 in control group) at the end of the two week pro-
gram, but the intervention group had significantly greater
reductions in body weight and waist circumference. The
significant difference in weight loss, in the absence of a
significant difference in reported energy intake between
the two groups, may be due to better compliance to the
program, as reported by the intervention group, or it could
be an indication of higher inaccuracies in dietary intake
reporting by the control group. One of the reasons for the
efficacy of a meal replacement program in weight reduc-
tion is attributed to better portion control, which could
result in reduced errors in reporting dietary intake, due to
automatic portion control of the pre-weighed meal. Self-
reported dietary intake data has been shown to be under-
reported in overweight individuals and individuals want-
ing to lose weight.39,40 It has also been observed that indi-
viduals who under-report, generally report consuming a
greater amount of healthy foods like fruits and vegetables
and consuming less unhealthy foods such as pastries.41
Thus, while under-reporting may have occurred in both
groups, it is possible that there was a greater degree of
under-reporting in the control group, and this could have
been one of the reasons for conflicting findings of similar
energy intakes, but greater reductions in body weight and
waist circumference in the intervention group.
The cost of the intervention (cereal, milk and fruit) was
about Rs 125-135 (~1.8-2 USD/day) and Rs 1900 (~28
USD) for the two week duration. The intervention re-
placed two meals in a day, and since the cost of the two
regular meals would approximately be the same or more,
the cost implications of the intervention were not high,
even if continued for a follow up period of greater than
two weeks.
The present study had certain limitations – the study
was only performed for two weeks and did not schedule
any follow up visits. Only female participants were stud-
ied and it is also possible that in these premenopausal
women of both study groups, menstrual cycle could have
been a confounder. Blinding of the subjects to the as-
signed groups was not possible in the present study and
this could have had some effect on compliance. The pro-
vision of free intervention product as compared with the
usual care advice may have introduced some bias, how-
ever this was not explored.
Conclusion
Portion controlled meal replacements can be used as an
effective strategy for short term weight loss with signifi-
cant improvement in the nutrient profile of the individual.
However, for prolonged maintenance of weight loss, a
judicious combination of diet, physical activity and be-
havior modifications needs to be followed. Future studies
need to investigate the effects over long periods of time in
obese and overweight populations to gauge the efficacy
of ready to eat cereals on sustained reduction in body
weight.
ACKNOWLEDGEMENTS
The authors would like to thank all the subjects of the study.
AUTHOR DISCLOSURES
The authors did not have any conflict of interest. Financial sup-
port was by Kellogg India Private Limited.
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