Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07452757
Eligibility Criteria:
Inclusion Criteria:
* \- Male and female subjects age between 20 to 45 years
* Non-pregnant and non-lactating
* Body Mass Index (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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
45 Years
Study:
NCT07452757
Study Brief:
Protocol Section:
NCT07452757