CTRI/2024/04/065016
Not yet recruiting
Not Applicable
An open label, single arm, prospective, multicentric, interventional clinical study to evaluate the effect of Meal Replacement Supplement on weight management in overweight / obese patients.
Dr. Reddys Laboratories Ltd.2 sites in 1 country150 target enrollmentStarted: April 8, 2024Last updated:
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Dr. Reddys Laboratories Ltd.
- Enrollment
- 150
- Locations
- 2
- Primary Endpoint
- 1) Assessment of body weight, waist and hip circumference, waist–hip ratio (WHR) and body mass index (BMI).
Overview
Brief Summary
This is an open label, single arm, multicentric clinical study to evaluate the effect of a meal replacement supplement in weight management in overweight / obese patients.
The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects.
All eligible subjects will undergo blood tests and clinical assessment. Subjective feedback will also be taken regarding the changes in daily dietary intake. Safety will be assessed throughout the study by monitoring adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Masking
- None
Eligibility Criteria
- Ages
- 18.00 Year(s) to 60.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Subjects with BMI from 23 kg/m2 to 32 kg/m
- •Subjects with a history of stable weight, defined as no significant weight change (± 5%) within three months prior to enrollment.
- •Subjects not participating in similar program or not using any natural/ herbal supplement or any other drug/nutraceutical for weight loss.
- •Subjects able to adjust diet or take nutrition and supplements daily with the guidance of a nutritionist.
- •Female subjects of childbearing potential must have a negative urine pregnancy test performed at screening visit.
- •Subjects who are willing to participate in the study and give voluntary written informed consent.
- •Subjects who are willing and able to follow the study protocol to participate in the study.
Exclusion Criteria
- •Subjects consuming probiotics / prebiotics 30 days prior to study.
- •Subjects using supplements that are rich in dietary fibre or protein which influences satiety assessment.
- •Subjects taking appetite stimulants or on steroid treatment or on hormone therapy.
- •Subjects who have a history of Insulin dependent diabetes / with Type I diabetes / with uncontrolled Type 2 diabetes.
- •Subjects who have hypothyroidism or hyperthyroidism as confirmed by lab test (T3, T4, TSH).
- •Subjects having limitation in doing physical activity/exercise for at least 20 to 30 mins daily.
- •Subjects who have undergone hospitalization for an infectious condition within 4 weeks prior to study entry.
- •Subjects participating in other similar therapeutic trials within the last four weeks.
Outcomes
Primary Outcomes
1) Assessment of body weight, waist and hip circumference, waist–hip ratio (WHR) and body mass index (BMI).
Time Frame: Day 00 (before product administration), Day 31, Day 61 and Day 91
2) Assessment of Basal Metabolic Rate, Skeletal Muscle Mass, Body Fat Mass and % Body Fat using Body Composition Analyzer.
Time Frame: Day 00 (before product administration), Day 31, Day 61 and Day 91
Secondary Outcomes
- Assessment of glycated hemoglobin levels (HbA1c).(Day 00 (before product administration), Day 91)
- Assessment of Fasting Blood Glucose and Post Prandial Blood Glucose(Day 00 (before product administration), Day 61, Day 91)
- Assessment of Total cholesterol, Triglycerides, LDL and HDL levels.(Day 00 (before product administration), Day 61, Day 91)
- 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.(Day 00 (before product administration), Day 31, Day 61, Day 91)
- Assessment of likeliness of feeling hunger and increase in subjective satiety using Visual analog scale (VAS)(Day 00 (before product administration), Day 31, Day 61, Day 91)
Investigators
Dr Parth Joshi
Cliantha Reseach
Study Sites (2)
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