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

Overview

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.

Interventions

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

Primary outcome measures

• To determine the effect of resM™ on weight [Time frame: 8 weeks]
• To determine the effect of resM™ on BMI [Time frame: 8 weeks]
• To determine the effect of resM™ on food cravings [Time frame: 8 weeks]
• To determine the effect of resM™ on blood metabolic markers [Time frame: 8 weeks]
• To determine the effect of resM™ on blood metabolic markers [Time frame: 8 weeks]
• To determine the effect of resM™ on blood metabolic markers [Time frame: 8 weeks]

Secondary outcome measures (12)

• To determine the effect of resM™ on GLP-1 [Time frame: 8 weeks]
• To determine the effect of resM™ on DPP-4 [Time frame: 8 weeks]
• To determine the effect of resM™ on gut microbiome [Time frame: 8 weeks]
• To determine the effect of resM™ on depression [Time frame: 8 weeks]
• Change in Albumin after taking resM™ [Time frame: 8 weeks]
• Change in Albumin/Globulin ratio after taking resM™ [Time frame: 8 weeks]
• Change in Alkaline Phosphatase after taking resM™ [Time frame: 8 weeks]
• Change in Alanine Aminotransferase (ALT) after taking resM™ [Time frame: 8 weeks]
• Change in Aspartate Aminotransferase (AST) after taking resM™ [Time frame: 8 weeks]
• Change in BUN/Creatinine ratio after taking resM™ [Time frame: 8 weeks]
• Change in Calcium after taking resM™ [Time frame: 8 weeks]
• Change in Chloride after taking resM™ [Time frame: 8 weeks]

Eligibility criteria

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Other

Study locations

United States · 1 center

• Able Biolabs, LLC — Birmingham

Identifiers

NCT: NCT06911073 · ABL-032501

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗