To evaluate efficacy and safety of proprietary healthy diet combinations for weight management in overweight volunteers

Phase 1

• Conditions: Health Condition 1: E663- Overweight

• Registration Number: CTRI/2023/07/054680
• Lead Sponsor: Amway Global Services India Pvt Ltd,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: ot Yet Recruiting
• Sex: Not specified
• Target Recruitment: 0

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

-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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified