Status:
RECRUITING
A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health
Lead Sponsor:
ResBiotic Nutrition, Inc.
Collaborating Sponsors:
Able Biolabs, LLC
Conditions:
Obesity and Overweight
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.
Detailed Description
Obesity poses substantial health challenges contributing significantly to chronic metabolic disorders such as type 2 diabetes mellitus, cardiovascular disease, and diminished quality of life for peopl...
Eligibility Criteria
Inclusion
- Provide voluntary signed and dated informed consent.
- Be in good health as determined by medical history.
- Age between 18 and 65 yr (inclusive).
- Body Mass Index of 25.0 - 40.0 (inclusive).
- Subject agrees to maintain existing dietary and physical activity patterns throughout the study period.
- Agree to refrain from other probiotic and postbiotic supplement products throughout the duration of the trial.
- Subject is willing and able to comply with the study protocol.
- 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
- History of unstable or new-onset cardiovascular/cardiorespiratory, liver, or renal conditions.
- 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.
- Previous bariatric surgery.
- Current smokers or smoking within the past month.
- History of hyperparathyroidism or an untreated thyroid condition.
- History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin).
- 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).
- Chronic inflammatory condition (e.g., rheumatoid arthritis, Crohn's, ulcerative colitis, Lupus, HIV/AIDS, etc.).
- Previous medical diagnosis of gout or fibromyalgia.
- 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.
- Known sensitivity to any ingredient in the test formulations as listed in the product label.
- Currently participating in another research study with an investigational product or have been in another research study in the past 30 days.
Key Trial Info
Start Date :
May 2 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06911073
Start Date
May 2 2025
End Date
December 1 2025
Last Update
September 9 2025
Active Locations (1)
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1
Able Biolabs, LLC
Birmingham, Alabama, United States, 35203