Oral postbiotic to support weight loss and metabolic health

A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health

This trial will try an oral postbiotic supplement in adults with overweight or obesity to see if it helps with weight loss and metabolic health.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: ResBiotic Nutrition, Inc. (industry)
• Locations: 1 site (Birmingham, Alabama)
• Trial ID: NCT06911073 on ClinicalTrials.gov

What this trial studies

This interventional study gives overweight adults either an oral postbiotic supplement or a placebo and follows metabolic and weight-related measures over the treatment period. Eligible participants are 18–65 years old with a BMI of 25.0–40.0 and must maintain their usual diet and activity while avoiding other probiotic/postbiotic products. The rationale is that gut microbiome-derived postbiotics may influence appetite control, glucose regulation, insulin sensitivity, and systemic inflammation, potentially via pathways such as GLP-1 modulation. Safety screening excludes people with unstable cardiovascular, liver, or renal conditions or recent substance abuse.

Who should consider this trial

Good fit: Ideal candidates are generally healthy adults aged 18–65 with BMI 25.0–40.0 who can attend visits in Birmingham, avoid other probiotic/postbiotic products, and keep their usual diet and activity levels.

Not a fit: People with unstable cardiac, liver, or kidney disease, recent substance abuse, those outside the age/BMI range, or those unable to stop other probiotic/postbiotic supplements are unlikely to benefit or to be allowed to participate.

Why it matters

Potential benefit: If successful, the supplement could provide a non-drug option to help some people lose weight and improve insulin sensitivity and other metabolic markers.

How similar studies have performed: Previous microbiome-targeted and postbiotic interventions have shown promising but mixed results, and this specific postbiotic approach is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Provide voluntary signed and dated informed consent.
2. Be in good health as determined by medical history.
3. Age between 18 and 65 yr (inclusive).
4. Body Mass Index of 25.0 - 40.0 (inclusive).
5. Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
6. Agree to refrain from other probiotic and postbiotic supplement products throughout the duration of the trial.
7. Subject is willing and able to comply with the study protocol.
8. Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, be able to understand and read the questionnaires, and carry out all study-related procedures.

Exclusion Criteria:

1. History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
2. Alcohol abuse (more than 2 standard alcoholic drinks per day or more than 10 drinks per week) or drug abuse or dependence within the past 6 months.
3. Previous bariatric surgery.
4. Current smokers or smoking within the past month.
5. History of hyperparathyroidism or an untreated thyroid condition.
6. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
7. Other known gastrointestinal or metabolic conditions that might impact nutrient absorption or metabolism, e.g., short bowel syndrome, irritable bowel syndrome (IBS), diarrheal illnesses, history of colon resection, gastroparesis, Inborn-Errors-of-Metabolism (such as PKU).
8. Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
9. Previous medical diagnosis of gout or fibromyalgia.
10. Pregnant women, women trying to become pregnant, women less than 120 days postpartum or nursing women. Any woman that is sexually active will have to take report their pregnancy status prior to enrolling and during the trial if they become pregnant.
11. Known sensitivity to any ingredient in the test formulations as listed in the product label.
12. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.

Where this trial is running

Birmingham, Alabama

• Able Biolabs, LLC — Birmingham, Alabama, United States (RECRUITING)

Study contacts

• Principal investigator: Ahmed Abdelgawad, MD — Able Biolabs, LLC
• Study coordinator: Project Manager

Conditions: Obesity and Overweight, Postbiotic, Obesity, GLP-1, Metabolic health