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

ResBiotic Nutrition

Status: Enrolling

Conditions: Obesity and Overweight

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Postbiotic

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06911073

ABL-032501

Details and patient eligibility

About

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

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

1 capsule of placebo, taken once daily

Treatment:

Dietary Supplement: Placebo

Postbiotic Supplement

Experimental group

Description:

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

Treatment:

Dietary Supplement: Postbiotic