Can a postbiotic gummy help shed pounds? new trial investigates

NCT ID NCT07165431

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests whether a daily postbiotic gummy, combined with healthy eating advice, can help overweight or obese adults lose body fat and improve metabolic health. Over 12 weeks, 114 participants will be randomly assigned to receive either the postbiotic or a placebo gummy, alongside nutritional recommendations. Researchers will measure changes in body composition, blood sugar, and gut bacteria.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
postbiotic supplement (inactivated microorganism) in a gummy
What this could lead to
If it works, this could offer a simple, safe supplement to help with weight loss and improve metabolic health in people with overweight or obesity.
What could go wrong
This is an early-stage trial with only 114 participants, so results may not apply to everyone. The supplement may have little to no effect beyond standard dietary changes.

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

About 114 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 70 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 participants aged 18 to 70 years. * Volunteers with overweight or obesity (BMI: ≥ 27-39.9 kg/m²) and a body fat percentage of ≥ 30% for women and ≥ 20% for men. * Stable body weight (±5%) for at least the three months prior to study initiation. * Normal physical examination and vital signs, or clinically non-relevant findings for the purposes of the study (i.e., not related to metabolic health). * Subjects must be able to understand and willing to sign the informed consent form, and comply with all study procedures and requirements. * Continued pharmacological/hormonal treatment will be permitted provided it does not affect the study parameters and that the dosage has remained stable at least the previous three months to the start of the intervention. Treatment with insulin or any drug with a hypoglycemic effect will be excluded * Willingness to undergo all study procedures (including the daily consumption of a 1 g gummy during the intervention). * Time and geographic availability to attend the two on-site clinical evaluation sessions at the scheduled times (including a 3-hour session during visit 2). Exclusion Criteria: * Volunteers undergoing pharmacological treatment will be excluded if the treatment has not been stable for at least 3 months prior to study initiation. Excluded treatments include: * Those that alter gastrointestinal function. * Chronic use of stomach protectors. * Any hypoglycemic drugs or insulin. * Subjects with significant functional or structural abnormalities of the digestive system, such as malformations, angiodysplasias, active peptic ulcers, chronic inflammatory or malabsorption diseases, hiatal hernia, chronic reflux, etc. * Subjects who have undergone surgical interventions resulting in permanent sequelae in the digestive tract (e.g., gastroduodenostomy) or bariatric surgery. * Subjects with chronic metabolic diseases or obesity-related conditions, or systemic intestinal, hepatic, or renal diseases, including type 1 or 2 diabetes, severe dyslipidemia, uncontrolled thyroid disorders, cirrhosis, inflammatory bowel disease, untreated anemia, etc. (Non-alcoholic fatty liver disease will not be an exclusion criterion). * Exceeding the alcohol consumption limit established for each sex (more than 14 units per week for women and 20 units per week for men). * Pregnant or breastfeeding women, or those planning to become pregnant. * Use of nutritional supplements (such as weight loss supplements, newly initiated fiber supplements, probiotics, postbiotics, etc.) containing compounds that may affect study outcomes, unless the participant agrees to discontinue them during the 12-week intervention period and a minimum 15-day washout period prior to baseline measurements is ensured. * Blood donation within 14 days prior to the baseline visit. * Subjects with any type of cancer or undergoing cancer treatment, or for whom less than 5 years have passed since remission. * Subjects allergic to any component of the study product or to any other food that could interfere with or hinder study compliance. * Subjects presenting any type of cognitive and/or psychiatric impairment. * Subjects anticipated to have poor compliance or who, in the investigator's opinion, may have difficulty adhering to study procedures. * Subjects currently undergoing treatment for weight loss or body composition modification. * Subjects who are taking or have taken antibiotics within 60 days prior to the baseline visit.

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight Weight Loss

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Center for Nutrition Research

    RECRUITING

    Pamplona, Navarre, Spain

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