Actively Recruiting
A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health
Led by ResBiotic Nutrition, Inc. · Updated on 2025-09-09
80
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
R
ResBiotic Nutrition, Inc.
Lead Sponsor
A
Able Biolabs, LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of a specific oral postbiotic supplement on metabolic health in overweight adults. The study focuses on how this supplement may influence weight loss, body mass index (BMI), appetite control, blood metabolic markers, and related factors over an eight-week period. The trial addresses obesity-related metabolic dysfunction linked to gut microbiome changes, aiming to explore microbiome-based interventions for better weight and metabolic health management. Participants will be randomly assigned to one of two groups in a double-blind design: one group receives a daily capsule containing 40 mg of the postbiotic along with an herbal and vitamin blend, while the other group receives a daily placebo capsule. The intervention lasts for eight weeks, with the postbiotic group receiving active ingredients such as Vitamin D, Vitamin B12, Chromium, and a specific Lactobacillus plantarum strain, combined with herbal extracts. The placebo contains inactive ingredients only. During the study, participants will be monitored through various assessments including measurements of weight, BMI, food cravings, and blood tests for metabolic markers. Additional evaluations include depression scores and gut microbiome analysis. Safety is continuously assessed by tracking adverse events. Participants are expected to maintain their usual diet and physical activity, avoid other probiotic or postbiotic supplements, and comply with study procedures throughout the eight weeks.
CONDITIONS
Brief Title
A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history.
- Age between 18 and 65 years (inclusive).
- Body Mass Index of 25.0 to 40.0 (inclusive).
- Agree to maintain existing dietary and physical activity patterns throughout the study.
- Agree to avoid other probiotic and postbiotic supplements during the trial.
- Willing and able to comply with the study protocol.
- Able to understand, read questionnaires, and complete all study procedures.
You will not qualify if you...
- History of unstable or new-onset cardiovascular, cardiorespiratory, liver, or kidney conditions.
- Alcohol abuse (more than 2 standard drinks per day or over 10 drinks per week) or drug abuse in the past 6 months.
- Previous bariatric surgery.
- Current smokers or smoked within the past month.
- History of hyperparathyroidism or untreated thyroid conditions.
- History of cancer in the past 5 years except certain skin cancers.
- Other gastrointestinal or metabolic conditions affecting nutrient absorption or metabolism.
- Chronic inflammatory conditions such as rheumatoid arthritis, Crohn's disease, lupus, or HIV/AIDS.
- Previous diagnosis of gout or fibromyalgia.
- Pregnancy, trying to become pregnant, less than 120 days postpartum, or nursing.
- Known sensitivity to any ingredients in the study products.
- Participation in another clinical trial with an investigational product within the past 30 days.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants take one capsule daily of either the postbiotic supplement or placebo for weight loss and metabolic health support.
1 baseline visit and weekly visits for 8 weeks
Trial Site Locations
Total: 1 location
1
Able Biolabs, LLC
Birmingham, Alabama, United States, 35203
Actively Recruiting
Research Team
P
Project Manager
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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