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

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

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

Study Overview

• Status: Recruiting
• Conditions: Obesity and Overweight
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Postbiotic

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Project Manager; Phone Number: 617-634-3675; Email: clinical@ablebiolabs.com

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35203
      • Recruiting
      • Able Biolabs, LLC
      • Contact: Moroni Berrios; Phone Number: 3612496084; Email: moroni@ablebiolabs.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; 1 capsule of placebo, taken once daily	Dietary supplement: Placebo; Active ingredients: N/A Inactive ingredients: Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate
Experimental: Postbiotic Supplement; 1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily	Dietary supplement: 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; Other Names: resM™ GLP-1 Postbiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
To determine the effect of resM™ on GLP-1	Change from baseline in plasma active and inactive GLP-1 protein	8 weeks
To determine the effect of resM™ on DPP-4	Change from baseline in plasma DPP4	8 weeks
To determine the effect of resM™ on gut microbiome	Change from baseline in gut microbiome as assessed by 16s metagenomic sequencing on fecal samples	8 weeks
To determine the effect of resM™ on depression	Change from baseline in reported depression levels based on Patient Health Questionnaire 9 (PHQ-9) scores. The total score reflects the severity of depression where 1 indicates minimal depression and 27 indicates severe depression.	8 weeks
Change in Albumin after taking resM™	Change from baseline in Albumin	8 weeks
Change in Albumin/Globulin ratio after taking resM™	Change from baseline in Albumin/Globulin ratio	8 weeks
Change in Alkaline Phosphatase after taking resM™	Change from baseline in Alkaline Phosphatase	8 weeks
Change in Alanine Aminotransferase (ALT) after taking resM™	Change from baseline in Alanine Aminotransferase (ALT)	8 weeks
Change in Aspartate Aminotransferase (AST) after taking resM™	Change from baseline in Aspartate Aminotransferase (AST)	8 weeks
Change in BUN/Creatinine ratio after taking resM™	Change from baseline in blood urea nitrogen (BUN)/creatinine ratio	8 weeks
Change in Calcium after taking resM™	Change from baseline in calcium	8 weeks
Change in Chloride after taking resM™	Change from baseline in chloride	8 weeks
Change in Glucose after taking resM™	Change from baseline in glucose	8 weeks
Change in Sodium after taking resM™	Change from baseline in sodium	8 weeks
Change in Total Bilirubin after taking resM™	Change from baseline in total bilirubin	8 weeks
Change in Total Protein after taking resM™	Change from baseline in total protein	8 weeks
Change in Urea Nitrogen after taking resM™	Change from baseline in Urea Nitrogen	8 weeks
Change in White Blood Cell (WBC) count after taking resM™	Change from baseline in white blood cell (WBC) count	8 weeks
Change in Red Blood Cell (RBC) count after taking resM™	Change from baseline in red blood cell (RBC) count	8 weeks
Change in Hemoglobin (Hb) after taking resM™	Change from baseline in hemoglobin (Hb)	8 weeks
Change in Hematocrit (Hct) after taking resM™	Change from baseline in hematocrit (Hct)	8 weeks
Change in Mean Corpuscular Volume (MCV) after taking resM™	Change from baseline in mean corpuscular volume (MCV)	8 weeks
Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™	Change from baseline in mean corpuscular hemoglobin (MCH)	8 weeks
Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™	Change from baseline in mean corpuscular hemoglobin concentration (MCHC)	8 weeks
Change in Red Cell Distribution Width (RDW) after taking resM™	Change from baseline in red cell distribution width (RDW)	8 weeks
Change in Platelet Count after taking resM™	Change from baseline in platelet count	8 weeks
Change in Mean Platelet Volume (MPV) after taking resM™	Change from baseline in Mean Platelet Volume (MPV)	8 weeks
Change in Neutrophils after taking resM™	Change from baseline in neutrophil count (absolute) and differential (percent)	8 weeks
Change in Lymphocytes after taking resM™	Change from baseline in lymphocyte count (absolute) and differential (percent)	8 weeks
Change in Monocytes after taking resM™	Change from baseline in monocyte count (absolute) and differential (percent)	8 weeks
Change in Eosinophils after taking resM™	Change from baseline in eosinophil count (absolute) and differential (percent)	8 weeks
Change in Basophils after taking resM™	Change from baseline in basophil count (absolute) and differential (percent)	8 weeks
Safety - participants experiencing adverse events	The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)	8 weeks
Safety - total adverse events	The total number of Treatment Emergent Adverse Events (TEAEs)	8 weeks

Collaborators and Investigators

• Sponsor: ResBiotic Nutrition, Inc.
• Collaborators: Able Biolabs, LLC
• Investigators: Principal Investigator: Ahmed Abdelgawad, MD, Able Biolabs, LLC

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 20, 2025
• First Submitted That Met QC Criteria: March 27, 2025
• First Posted (Actual): April 4, 2025

Study Record Updates

• Last Update Posted (Estimated): September 9, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Obesity; GLP-1; Metabolic health; Postbiotic
• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Overweight; Obesity; Substandard Drugs; Pharmaceutical Preparations; Counterfeit Drugs
• Other Study ID Numbers: ABL-032501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No