Clinical trial NCT06911073: A Study to Evaluate a Postbiotic in Supporting Weight Loss and Metabolic Health
Official title: A Double-Blind, Randomized Placebo-Controlled Study to Evaluate a Postbiotic Supplement in Supporting Weight Loss and Metabolic Health
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Obesity and Overweight
Keywords: Postbiotic
Obesity
GLP-1
Metabolic health
Lead sponsor: ResBiotic Nutrition, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Able Biolabs, LLC
First posted: 2025-04-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomization at 1:1 ratio of active:placebo
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: To determine the effect of resM™ on weight
timeFrame: 8 weeks
measure: To determine the effect of resM™ on BMI
timeFrame: 8 weeks
measure: To determine the effect of resM™ on food cravings
timeFrame: 8 weeks
measure: To determine the effect of resM™ on blood metabolic markers
timeFrame: 8 weeks
measure: To determine the effect of resM™ on blood metabolic markers
timeFrame: 8 weeks
measure: To determine the effect of resM™ on blood metabolic markers
timeFrame: 8 weeks
Secondary outcomes:
measure: To determine the effect of resM™ on GLP-1
timeFrame: 8 weeks
measure: To determine the effect of resM™ on DPP-4
timeFrame: 8 weeks
measure: To determine the effect of resM™ on gut microbiome
timeFrame: 8 weeks
measure: To determine the effect of resM™ on depression
timeFrame: 8 weeks
measure: Change in Albumin after taking resM™
timeFrame: 8 weeks
measure: Change in Albumin/Globulin ratio after taking resM™
timeFrame: 8 weeks
measure: Change in Alkaline Phosphatase after taking resM™
timeFrame: 8 weeks
measure: Change in Alanine Aminotransferase (ALT) after taking resM™
timeFrame: 8 weeks
measure: Change in Aspartate Aminotransferase (AST) after taking resM™
timeFrame: 8 weeks
measure: Change in BUN/Creatinine ratio after taking resM™
timeFrame: 8 weeks
measure: Change in Calcium after taking resM™
timeFrame: 8 weeks
measure: Change in Chloride after taking resM™
timeFrame: 8 weeks
measure: Change in Glucose after taking resM™
timeFrame: 8 weeks
measure: Change in Sodium after taking resM™
timeFrame: 8 weeks
measure: Change in Total Bilirubin after taking resM™
timeFrame: 8 weeks
measure: Change in Total Protein after taking resM™
timeFrame: 8 weeks
measure: Change in Urea Nitrogen after taking resM™
timeFrame: 8 weeks
measure: Change in White Blood Cell (WBC) count after taking resM™
timeFrame: 8 weeks
measure: Change in Red Blood Cell (RBC) count after taking resM™
timeFrame: 8 weeks
measure: Change in Hemoglobin (Hb) after taking resM™
timeFrame: 8 weeks
measure: Change in Hematocrit (Hct) after taking resM™
timeFrame: 8 weeks
measure: Change in Mean Corpuscular Volume (MCV) after taking resM™
timeFrame: 8 weeks
measure: Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™
timeFrame: 8 weeks
measure: Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™
timeFrame: 8 weeks
measure: Change in Red Cell Distribution Width (RDW) after taking resM™
timeFrame: 8 weeks
measure: Change in Platelet Count after taking resM™
timeFrame: 8 weeks
measure: Change in Mean Platelet Volume (MPV) after taking resM™
timeFrame: 8 weeks
measure: Change in Neutrophils after taking resM™
timeFrame: 8 weeks
measure: Change in Lymphocytes after taking resM™
timeFrame: 8 weeks
measure: Change in Monocytes after taking resM™
timeFrame: 8 weeks
measure: Change in Eosinophils after taking resM™
timeFrame: 8 weeks
measure: Change in Basophils after taking resM™
timeFrame: 8 weeks
measure: Safety - participants experiencing adverse events
timeFrame: 8 weeks
measure: Safety - total adverse events
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Able Biolabs, LLC
name: Ahmed Abdelgawad, MD
role: PRINCIPAL_INVESTIGATOR
References: