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

NCT06911073 | Recruiting

• 1 other identifier: ABL-032501
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the impact of a specific oral postbiotic supplement on metabolic health in overweight adults.

Conditions

Obesity and Overweight

Keywords

Postbiotic; Obesity; GLP-1; Metabolic health

Outcome Measures

Primary Outcomes (6)

• To determine the effect of resM™ on weight

  Change from baseline in weight (lb)

  8 weeks

• To determine the effect of resM™ on BMI

  Change from baseline in BMI. Weight and height will be combined to report BMI in kg/m\^2)

  8 weeks

• To determine the effect of resM™ on food cravings

  Change in reported food cravings from baseline based on Food Craving Questionnaire Trait-reduced (FCQ-T-r) scores. The total score reflects the severity of food cravings where 90 indicates the most severe and 15 indicates the least severe.

  8 weeks

• To determine the effect of resM™ on blood metabolic markers

  Change from baseline in serum fasting glucose

  8 weeks

• To determine the effect of resM™ on blood metabolic markers

  Change from baseline in serum insulin levels

  8 weeks

• To determine the effect of resM™ on blood metabolic markers

  Change from baseline in whole blood HbA1c (glycated hemoglobin)

  8 weeks

Secondary Outcomes (34)

• To determine the effect of resM™ on GLP-1

  8 weeks

• To determine the effect of resM™ on DPP-4

  8 weeks

• To determine the effect of resM™ on gut microbiome

  8 weeks

• To determine the effect of resM™ on depression

  8 weeks

• Change in Albumin after taking resM™

  8 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

1 capsule of placebo, taken once daily

Dietary Supplement: Placebo

Postbiotic Supplement

EXPERIMENTAL

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

Dietary Supplement: Postbiotic

Interventions

Postbiotic 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

Also known as: resM™ GLP-1 Postbiotic

Postbiotic Supplement

Placebo DIETARY_SUPPLEMENT

Active ingredients: N/A Inactive ingredients: Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ResBiotic Nutrition, Inc.: lead
• Able Biolabs, LLC: collaborator

Study Sites (1)

Able Biolabs, LLC

Birmingham, Alabama, 35203, United States

RECRUITING

MeSH Terms

Conditions

Obesity; Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ahmed Abdelgawad, MD

  Able Biolabs, LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

617-634-3675; clinical@ablebiolabs.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomization at 1:1 ratio of active:placebo

Study Record Dates

• First Submitted: March 20, 2025
• First Posted: April 4, 2025
• Study Start: May 2, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 9, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)