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The goal of this clinical trial is to evaluate the physiological effects of a WM Formula on glucagon-like peptide-1 (GLP-1) secretion and glycemic regulation in adults with elevated body fat percentage. The WM Formula is a multi-component dietary supplement composed of Bifidobacterium breve (Active), Rocket Apple Extract Powder (Active), Probio-kombu Black Tea Powder (Active), Soy Protein (Excipient), Gum Acacia (Excipient), and Erythritol (Excipient).
Participants enrolled in the study will be required to undergo blood collection, height measurement, body composition analysis, and questionnaire completion. Each testing session will take approximately 5 hours, and participants will need to complete two trial visits in total. There will be a 7-day washout period between the two trial sessions (i.e., after completion of the first trial, the second trial will be scheduled at least 7 days later). On each trial day, blood samples and relevant assessments will be conducted at the following time points: before ingestion of the test product or placebo, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion.
This study is a double-blind, single-center, crossover clinical trial in which each participant serves as their own control. The aim is to evaluate the effects of the WM Formula dietary supplement on promoting endogenous GLP-1 secretion and suppressing appetite in adults with elevated body fat percentage.
Eligible participants will be adults aged between 18 and 65 years, screened based on body fat percentage and BMI.
Inclusion criteria:
Exclusion criteria:
After enrollment, participants will be required to visit TCI Co., Ltd. for blood collection, height and body composition measurements, and completion of questionnaires. Each study visit will take approximately 5 hours, and participants will undergo two test sessions, separated by a 7-day washout period (i.e., after completing the first test, the second will occur at least 7 days later).
On each test day, blood samples (~14 mL per time point) will be collected via an indwelling venous catheter at the following time points: before ingestion of the test product or placebo, and at 15, 30, 45, 60, 90, 120, and 240 minutes post-ingestion. The blood samples will be analyzed for GLP-1, DPP-4, complete blood count (CBC), blood glucose, and insulin concentrations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Intervention: Control group | Placebo Comparator | Participants in the control group will consume 50 mL water |
|
| Experimental: WM formula Group | Active Comparator | Participants in the intervention group will consume a single dose of WM formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WM formula Group | Dietary Supplement | Participants in the intervention group will consume a single dose of WM formula drink (50 mL) on the study day. The formula includes Bifidobacterium breve (probiotic), ClpB formula (prebiotic), and Rocket Apple extract. The ClpB formula consists of kombucha, soy peptide powder, arabic gum (gum acacia) and erythritol. |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma GLP-1 concentration (pmol/L) | Plasma GLP-1 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7. | Day 1 and Day 7 |
| Blood glucose concentration (mg/dL) | Blood glucose levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7. | Day 1 and Day 7 |
| Serum insulin concentration (μIU/mL) | Serum insulin levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7. | Day 1 and Day 7 |
| Plasma DPP-4 concentration (ng/mL) | Plasma DPP-4 levels will be measured at fasting and at 15, 30, 45, 60, 90, 120, and 240 minutes after consumption of the WM Formula on Days 1 and 7. | Day 1 and Day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TCI Co., Ltd. | Taipei | Taiwan |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000068858 | Kombucha Tea |
| D006170 | Gum Arabic |
| D004896 | Erythritol |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D013662 | Tea |
| D028321 | Plant Preparations |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
|
| Control group | Other | Participants in the control group will consume 50 mL water |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D000088082 |
| Fermented Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D000074421 | Fermented Foods |
| D019602 | Food and Beverages |
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |