New weight loss program combines supplements, diet, and exercise to fight obesity

NCT ID NCT07452757

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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

140 people

The number who actually took part.

Started

Nov 2023

Finished

May 2024

Lead sponsor

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

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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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