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The AKK formula, a prebiotic blend, can effectively promote the proliferation of A. muciniphila. In this study, we attempt to explore the clinical efficacy of AKK formula for A. muciniphila proliferation and weight management.
This is a double-blind, randomized, parallel and placebo-controlled study. Subjects are informed to consume the samples daily for 8 weeks. The person who is evaluated as obesity by the investigator will be invited to participate in this trial. In this study, we attempt to explore the clinical efficacy of AKK formula for A. muciniphila proliferation and weight management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo sachet | Placebo Comparator | consume 1 sachet per day for 8 weeks |
|
| AKK formula sachet | Experimental | consume 1 sachet per day for 8 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AKK formula prebiotic sachet | Dietary Supplement | 5 g/sachet, containing AKK formula, Indigestible Maltodextrin, Crystalline Maltitol, Calcium Carbonate, Citric Acid, Steviol Glycosides, and flavor. Subjects will consume 1 sachet per day for 8 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Relative abundance of Akkermansia muciniphila in gut | Collect subject's feces for bacterial analysis. Akkermansia muciniphila will be quantified by quantitative PCR. | Change from Baseline relative abundance of A. muciniphila at 8 weeks |
| The change of waist circumference | The waist circumference will be assessed by measuring tape. Unit: centimeter | Change from Baseline waist circumference at 4 weeks, and 8 weeks |
| The change of Waist-to-height ratio | Waist-to-height ratio can be obtained by dividing waist size by height and is an effective indicator of risks associated with obesity. | Change from Baseline Waist-to-height at 4 weeks, and 8 weeks |
| The change of body mass index (BMI) | BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m^2) and body mass (kg) will be assessed by InBody. | Change from Baseline BMI at 4 weeks, and 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The change of total body mass | The total body mass (kg) will be assessed by Bioelectrical impedance analysis (BIA). | Change from Baseline total body mass at 4 weeks, and 8 weeks |
| The change of total lean mass |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ming-Ta Yang | Taipei Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Medical University | Taipei | 110 | Taiwan |
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| ID | Term |
|---|---|
| D001836 | Body Weight Changes |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007333 | Insulin Resistance |
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| Placebo sachet | Dietary Supplement | 5 g/sachet, containing Indigestible Maltodextrin, Crystalline Maltitol, Calcium Carbonate, Citric Acid, Steviol Glycosides, and flavor. Subjects will consume 1 sachet per day for 8 weeks. |
|
The total lean mass (kg) will be assessed by Bioelectrical impedance analysis (BIA).
| Change from Baseline total lean mass at 4 weeks, and 8 weeks |
| The change of total fat mass | The total fat mass (kg) will be assessed by Bioelectrical impedance analysis (BIA). | Change from Baseline total fat mass at 4 weeks, and 8 weeks |
| The change of total fat rate | The total fat rate (%) will be assessed by Bioelectrical impedance analysis (BIA). | Change from Baseline total fat rate at 4 weeks, and 8 weeks |
| The change of visceral fat volume | The visceral fat volume (cm^2) will be assessed by Bioelectrical impedance analysis (BIA). | Change from Baseline visceral fat volume at 4 weeks, and 8 weeks |
| The change of hip circumference | The hip circumference will be assessed by measuring tape. Unit: centimeter | Change from Baseline hip circumference at 4 weeks, and 8 weeks |
| The change of insulin sensitivity | Insulin sensitivity is assessed by HOMA-IR. HOMA-IR= fasting insulin (microU/L) x fasting glucose (nmol/L)/22.5. Venous blood will be sampled to measure concentrations of fasting glycemia and insulin. | Change from Baseline insulin sensitivity at 8 weeks |
| The change of total cholesterol | Venous blood will be sampled to measure concentrations of total cholesterol. | Change from Baseline total cholesterol at 8 weeks |
| The change of High Density Lipoprotein Cholesterol (HDL-C) | Venous blood will be sampled to measure concentrations of HDL-C. | Change from Baseline HDL-C at 8 weeks |
| The change of Low Density Lipoprotein Cholesterol (LDL-C) | Venous blood will be sampled to measure concentrations of LDL-C. | Change from Baseline LDL-C at 8 weeks |
| The change of triglyceride | Venous blood will be sampled to measure concentrations of triglyceride. | Change from Baseline triglyceride at 8 weeks |
| The change of intestinal microbiota | Collect subject's feces for bacterial analysis. Intestinal microbiota will be assessed by Next Generation Sequencing (NGS). | Change from Baseline intestinal microbiota at 8 weeks |
| The change of gastrointestinal tolerability | Gastointestinal tolerability will be assessed by The Gastrointestinal Symptom Rating Scale (GSRS).The GSRS has a seven-point graded Likert-type scale where 1 represents absence of troublesome symptoms and 7 represents very troublesome symptoms. | Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks |
| The change of stool type | The stool type will be assessed by The Bristol Stool Form Scale (BSFS) daily. The BSFS is a scale that classifies stools, ranging from the hardest (type 1) to the softest (type 7). | Change from Baseline gastrointestinal tolerability at 4 weeks, and 8 weeks |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |