RECRUITING

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

Conditions

Obesity and Overweight Postbiotic Obesity GLP-1 Metabolic health

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-05-02

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06911073

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Project Manager

CONTACT

617-634-3675

clinical@ablebiolabs.com

Principal Investigator

Ahmed Abdelgawad, MD

PRINCIPAL_INVESTIGATOR

Able Biolabs, LLC

Study Locations (Sites)

Able Biolabs, LLC

Birmingham, Alabama, 35203

United States

Collaborators and Investigators

Sponsor: ResBiotic Nutrition, Inc.

Ahmed Abdelgawad, MD, PRINCIPAL_INVESTIGATOR, Able Biolabs, LLC

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-02

Study Completion Date2025-12

Study Record Updates

Study Start Date2025-05-02

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

Postbiotic
Obesity
GLP-1
Metabolic health

Additional Relevant MeSH Terms

Obesity and Overweight