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| Name | Class |
|---|---|
| Able Biolabs, LLC | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1 capsule of placebo, taken once daily |
|
| Postbiotic Supplement | Experimental | 1 capsule of 40 mg postbiotic, 450 mg herbal blend, and 810 mcg vitamins taken once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Postbiotic | Dietary 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Project Manager | Contact | 617-634-3675 | clinical@ablebiolabs.com |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Abdelgawad, MD | Able Biolabs, LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Able Biolabs, LLC | Recruiting | Birmingham | Alabama | 35203 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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Randomization at 1:1 ratio of active:placebo
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| Placebo | Dietary Supplement | Active ingredients: N/A Inactive ingredients: Microcrystalline cellulose, hydroxypropyl methylcellulose, magnesium stearate, silica, water, carrageenan, potassium acetate |
|
| 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 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |