Health Condition 1: E663- Overweight
Conditions
Interventions
Intervention1: PRP-02- 10 minutes before all 3 meals- ideal to mix with buttermilk/ skimmed milk / water.: Morning- PRP-02 (1 scoop) + AND-16
Afternoon- PRP-02 (1 scoop)
Night-PRP-02 (1 scoop) + FBR-1
FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO â?? 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)
Interv
FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO â?? 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)
Inter
FBR - 18 twice daily (1 scoop 30 minutes before breakfast and dinner fixed in 250 ml of water) and 1 capsule of PRO â?? 19 post dinner. Intensive Phase (30 days) and Maintenance Phase (60 days)
Contr
Sponsors
Amway Global Services India Pvt Ltd,
Eligibility
Inclusion criteria
Inclusion criteria: Male and female subjects age between 20 to 45 years Non-pregnant and non-lactating BMI (kg/m2)- >= 23 (considered overweight/obese as per the ethnicity cut off values for Asian Indians) Following stable eating habits Not on any medication that can affect Lipid profile, body composition or weight Nonalcoholic and non- smoker Subjects who are willing to sign the informed consent and comply with study requirement of meal replacements strictly. Women in the reproductive age group- should be agreeing to follow standard contraceptive measures Individuals who are seriously motivated to lose weight and willing to be part of any one of the interventions where Protein drink with buttermilk, skimmed milk or water OR 1 Meal replacement OR 2 Meal replacement would be given.
Exclusion criteria
Exclusion criteria: -On medication/ HRT (Hormone Replacement Therapy) -Suffering from endocrine hypothalamic- pituitary disease, women with PCOS, adrenal disorder, hypothyroidism, -Subjects with Diabetes type 1 or 2 to be excluded -Women in the reproductive age group not willing to use standard contraceptive measures. -Other conditions like CKD, stones, liver dysfunction (with elevated enzyme levels), history of cancer, eating disorders, chronic gastrointestinal disorders (IBD or celiac), metabolic disorders like hypertension, CVDs- that might impair the outcomes -Malignancy which is currently active or in remission for less than five years after last treatment -Unstable weight (± 5 % fluctuation in their body weight for past 8-weeks at study entry) -Have undergone gastroplasty or weight reducing surgery -Subjects who have participated in another clinical study within the past 30 days prior to screening or are likely to simultaneously participate in another clinical study. -Practicing any structured commercial weight management program/ intermittent fasting or any diet regime in the last 30 days prior to screening. -Patients who are doubtful to comply with study procedures for mental, psychological or social reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the intensive phase. To evaluate number & percentage of subjects demonstrating reduction in BMI/ weight between inter & intra arms from baseline to the end of the maintenance phase. Gut reset (-10 to Day 0) phase (except control arm): Will precede intensive and maintenance phase.Timepoint: Intensive phase (Day 1 to Day 30) During the intensive phase, all the intervention arms will be followed up on daily basis with -Daily Telephonic calls -Weekly once on-site visit Maintenance Phase (Day 31 to Day 60) During the maintenance phase, all the intervention arms will be followed up on weekly basis with -Weekly Telephonic call & -Biweekly once on-site visit | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the number of subjects between inter and intra arms maintaining the lost weight after intensive phase.Timepoint: Day 31 to Day 60;To evaluate the reduction in skinfold thickness and WHR among subjects between inter and intra armsTimepoint: Day 1 and Day 90;To evaluate the changes in Body fat percentage among subjects between inter and intra armsTimepoint: Day 1 and Day 90;To assess the number and percentage of subjects demonstrating improvement in lipid profile between inter and intra armsTimepoint: Day 1 and Day 90;To assess the number and percentage of subjects demonstrating improvement in parameters assessed by Body composition analyzerTimepoint: Day 1, Day 7, Day 15, Day 22, Day 30, Day 45, Day 60, Day 75 and Day90;Changes in the quality of life using WHOQOL- BREF between inter and intra armsTimepoint: Day 1 and Day 90;Changes in the clinical parameters between inter and intra armsTimepoint: Day 1 and Day 90;Incidence of any adverse events during study in each armTimepoint: Day 1 and Day 90;Compliance to the studyTimepoint: Day 7, 15, 22, 30, 37, 45,52, 60, 67, 75 and Day 82 | — |
Countries
India
Contacts
Public ContactDivya Chandradhara
BioAgile Therapeutics Pvt Ltd
Outcome results
None listed