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

ResBiotic Nutrition, Inc.80 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Obesity and Overweight

Interventions

PostbioticDIETARY_SUPPLEMENT

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

PlaceboDIETARY_SUPPLEMENT

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Able Biolabs, LLC

Birmingham, Alabama, United States

RECRUITING

Outcomes

Primary Outcomes

To determine the effect of resM™ on weight

Change from baseline in weight (lb)

Time frame: 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)

Time frame: 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.

Time frame: 8 weeks

To determine the effect of resM™ on blood metabolic markers

Change from baseline in serum fasting glucose

Time frame: 8 weeks

To determine the effect of resM™ on blood metabolic markers

Change from baseline in serum insulin levels

Time frame: 8 weeks

To determine the effect of resM™ on blood metabolic markers

Change from baseline in whole blood HbA1c (glycated hemoglobin)

Time frame: 8 weeks

Secondary Outcomes

To determine the effect of resM™ on GLP-1

Change from baseline in plasma active and inactive GLP-1 protein

Time frame: 8 weeks

To determine the effect of resM™ on DPP-4

Change from baseline in plasma DPP4

Central Contacts

Project Manager

CONTACT

617-634-3675 clinical@ablebiolabs.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

To determine the effect of resM™ on gut microbiome

Change from baseline in gut microbiome as assessed by 16s metagenomic sequencing on fecal samples

Time frame: 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.

Time frame: 8 weeks

Change in Albumin after taking resM™

Change from baseline in Albumin

Time frame: 8 weeks

Change in Albumin/Globulin ratio after taking resM™

Change from baseline in Albumin/Globulin ratio

Time frame: 8 weeks

Change in Alkaline Phosphatase after taking resM™

Change from baseline in Alkaline Phosphatase

Time frame: 8 weeks

Change in Alanine Aminotransferase (ALT) after taking resM™

Change from baseline in Alanine Aminotransferase (ALT)

Time frame: 8 weeks

Change in Aspartate Aminotransferase (AST) after taking resM™

Change from baseline in Aspartate Aminotransferase (AST)

Time frame: 8 weeks

Change in BUN/Creatinine ratio after taking resM™

Change from baseline in blood urea nitrogen (BUN)/creatinine ratio

Time frame: 8 weeks

Change in Calcium after taking resM™

Change from baseline in calcium

Time frame: 8 weeks

Change in Chloride after taking resM™

Change from baseline in chloride

Time frame: 8 weeks

Change in Glucose after taking resM™

Change from baseline in glucose

Time frame: 8 weeks

Change in Sodium after taking resM™

Change from baseline in sodium

Time frame: 8 weeks

Change in Total Bilirubin after taking resM™

Change from baseline in total bilirubin

Time frame: 8 weeks

Change in Total Protein after taking resM™

Change from baseline in total protein

Time frame: 8 weeks

Change in Urea Nitrogen after taking resM™

Change from baseline in Urea Nitrogen

Time frame: 8 weeks

Change in White Blood Cell (WBC) count after taking resM™

Change from baseline in white blood cell (WBC) count

Time frame: 8 weeks

Change in Red Blood Cell (RBC) count after taking resM™

Change from baseline in red blood cell (RBC) count

Time frame: 8 weeks

Change in Hemoglobin (Hb) after taking resM™

Change from baseline in hemoglobin (Hb)

Time frame: 8 weeks

Change in Hematocrit (Hct) after taking resM™

Change from baseline in hematocrit (Hct)

Time frame: 8 weeks

Change in Mean Corpuscular Volume (MCV) after taking resM™

Change from baseline in mean corpuscular volume (MCV)

Time frame: 8 weeks

Change in Mean Corpuscular Hemoglobin (MCH) after taking resM™

Change from baseline in mean corpuscular hemoglobin (MCH)

Time frame: 8 weeks

Change in Mean Corpuscular Hemoglobin Concentration (MCHC) after taking resM™

Change from baseline in mean corpuscular hemoglobin concentration (MCHC)

Time frame: 8 weeks

Change in Red Cell Distribution Width (RDW) after taking resM™

Change from baseline in red cell distribution width (RDW)

Time frame: 8 weeks

Change in Platelet Count after taking resM™

Change from baseline in platelet count

Time frame: 8 weeks

Change in Mean Platelet Volume (MPV) after taking resM™

Change from baseline in Mean Platelet Volume (MPV)

Time frame: 8 weeks

Change in Neutrophils after taking resM™

Change from baseline in neutrophil count (absolute) and differential (percent)

Time frame: 8 weeks

Change in Lymphocytes after taking resM™

Change from baseline in lymphocyte count (absolute) and differential (percent)

Time frame: 8 weeks

Change in Monocytes after taking resM™

Change from baseline in monocyte count (absolute) and differential (percent)

Time frame: 8 weeks

Change in Eosinophils after taking resM™

Change from baseline in eosinophil count (absolute) and differential (percent)

Time frame: 8 weeks

Change in Basophils after taking resM™

Change from baseline in basophil count (absolute) and differential (percent)

Time frame: 8 weeks

Safety - participants experiencing adverse events

The number of participants experiencing Treatment Emergent Adverse Events (TEAEs)

Time frame: 8 weeks

Safety - total adverse events

The total number of Treatment Emergent Adverse Events (TEAEs)

Time frame: 8 weeks