New weight loss program combines supplements, diet, and exercise to fight obesity
NCT ID NCT07452757
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested a 100-day weight management program in 140 overweight adults. The program included meal replacements, protein and fiber supplements, probiotics, diet plans, exercise, and counseling. Researchers measured weight loss and health changes to see if the program is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- meal replacements, protein supplements, fiber supplements, probiotics, and multivitamins
- What this could lead to
- If it works, this could offer a structured, lifestyle-based approach to help overweight adults lose weight and improve metabolic health.
- What could go wrong
- This is a small, completed study without a placebo control, so results may not apply broadly. Weight loss programs often show variable long-term success.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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140 people
The number who actually took part.
- Started
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Nov 2023
- Finished
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May 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 to 45 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Sapthagiri Institute of Medical Sciences & Research Centre
Bangalore, Karnataka, 560090, India
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