Health Condition 1: E669- Obesity, unspecified
Conditions
Interventions
Intervention1: Meal Replacement Supplement: One serving (providing 50 gm of test product mixed in 250 ml of water) will be consumed per day instead on one meal i.e., Lunch/Dinner for duration of 90 da
Sponsors
Dr. Reddys Laboratories Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1) Subjects with BMI from 23 kg/m2 to 32 kg/m2. 2) Subjects with a history of stable weight, defined as no significant weight change (± 5%) within three months prior to enrollment. 3) Subjects not participating in similar program or not using any natural/ herbal supplement or any other drug/nutraceutical for weight loss. 4) Subjects able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist. 5) Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit. 6) Subjects who are willing to participate in the study and give voluntary written informed consent. 7) Subjects who are willing and able to follow the study protocol to participate in the study.
Exclusion criteria
Exclusion criteria: 1) Subjects consuming probiotics / prebiotics 30 days prior to study. 2) Subjects using supplements that are rich in dietary fibre or protein which influences satiety assessment. 3) Subjects taking appetite stimulants or on steroid treatment or on hormone therapy. 4) Subjects who have a history of Insulin dependent diabetes / with Type I diabetes / with uncontrolled Type 2 diabetes. 5) Subjects who have hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4, TSH). 6) Subjects having limitation in doing physical activity/exercise for at least 20 to 30 mins daily. 7) Subjects who have undergone hospitalization for an infectious condition within 4 weeks prior to study entry. 8) Subjects participating in other similar therapeutic trials within the last four weeks.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) Assessment of body weight, waist and hip circumference, waist–hip ratio (WHR) and body mass index (BMI). 2) Assessment of Basal Metabolic Rate, Skeletal Muscle Mass, Body Fat Mass and % Body Fat using Body Composition Analyzer.Timepoint: Day 00 (before product administration), Day 31, Day 61 and Day 91 | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of daily dietary intake (in terms of Total caloric intake, Carbohydrate intake, Protein intake, Fat intake and Fibre intake) using 24-hour dietary recall.Timepoint: Day 00 (before product administration), Day 31, Day 61, Day 91;Assessment of Fasting Blood Glucose and Post Prandial Blood GlucoseTimepoint: Day 00 (before product administration), Day 61, Day 91;Assessment of glycated hemoglobin levels (HbA1c).Timepoint: Day 00 (before product administration), Day 91;Assessment of likeliness of feeling hunger and increase in subjective satiety using Visual analog scale (VAS)Timepoint: Day 00 (before product administration), Day 31, Day 61, Day 91;Assessment of Total cholesterol, Triglycerides, LDL and HDL levels.Timepoint: Day 00 (before product administration), Day 61, Day 91 | — |
Countries
India
Contacts
Public ContactSukhada Bhatte
Dr Reddys Laboratories Ltd
Outcome results
None listed