A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health

NCT ID: NCT06911073

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-02
• Study Completion Date: 2025-12-31

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 people worldwide. Central to obesity-related metabolic dysfunction is dysregulation of appetite control, glucose homeostasis, insulin sensitivity, and systemic inflammation. Evidence indicates a strong connection between these metabolic disturbances and alterations in the gut microbiome, implicating microbiota dysbiosis as a potential target for intervention. Microbiome-based interventions underscore a promising approach in weight management and metabolic health.

Conditions

Obesity and Overweight

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Placebo

1 capsule of placebo, taken once daily

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate

Postbiotic Supplement

1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily

Group Type: EXPERIMENTAL

Postbiotic

Intervention Type: DIETARY_SUPPLEMENT

Active ingredients:

Vitamin D (as cholecalciferol) - 10 mcg Vitamin B12 (as methylcobalamin) - 200 mcg Chromium (as chromium picolinate) - 600 mcg resM™ Postbiotic (L. plantarum RSB11® HI - 16B cells) - 40 mg White mulberry (Morus alba) leaf extract - 250 mg Fenugreek (Trigonella foenum-graecum) seed extract - 200 mg

Inactive ingredients:

Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate

Interventions

Postbiotic

Active ingredients:

Vitamin D (as cholecalciferol) - 10 mcg Vitamin B12 (as methylcobalamin) - 200 mcg Chromium (as chromium picolinate) - 600 mcg resM™ Postbiotic (L. plantarum RSB11® HI - 16B cells) - 40 mg White mulberry (Morus alba) leaf extract - 250 mg Fenugreek (Trigonella foenum-graecum) seed extract - 200 mg

Inactive ingredients:

Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Active ingredients:

N/A

Inactive ingredients:

Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

resM™ GLP-1 Postbiotic

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Able Biolabs, LLC

OTHER

Sponsor Role: collaborator

ResBiotic Nutrition, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ahmed Abdelgawad, MD

Role: PRINCIPAL_INVESTIGATOR

Able Biolabs, LLC

Locations

Able Biolabs, LLC

Birmingham, Alabama, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Project Manager

Role: CONTACT

clinical@ablebiolabs.com

617-634-3675

Facility Contacts

Moroni Berrios

Role: primary

moroni@ablebiolabs.com

3612496084

Other Identifiers

ABL-032501

Identifier Type: -

Identifier Source: org_study_id