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Assess the effects of Akkermansia muciniphila Akk11 heat - killed bacteria capsules compared to a placebo on body composition indicators (weight, BMI, body fat rate, waist - hip ratio (WC), wrist circumference, visceral fat area, basal metabolic rate) and blood lipid concentrations (total cholesterol (TC), low - density lipoprotein (LDL), high - density lipoprotein (HDL), triglycerides (TG)) in overweight/obese adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Pasteurized Akkermansia muciniphila Akk11 capsule, 10 billion TFU/day |
|
| Placebo group | Placebo Comparator | Placebo capsule, one capsules/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8, week 12) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight before and after intervention | Measured using a calibrated scale | Week 0 , Week 4, Week 8, Week 12 |
| Change in BMI before and after intervention | Measured using a calibrated scale and stadiometer | Week 0 , Week 4, Week 8, Week 12 |
| Change in waist-hip ratio (WC) before and after intervention | Measured using a non-elastic measuring tape | Week 0 , Week 4, Week 8, Week 12 |
| Change in wrist circumference before and after intervention | Measured using a non-elastic measuring tape | Week 0 , Week 4, Week 8, Week 12 |
| Change in visceral fat area before and after intervention. | Measured using bioelectrical impedance analysis (BIA) | Week 0 , Week 4, Week 8, Week 12 |
| Change in basal metabolic rate (BMR) before and after intervention | Measured using indirect calorimetry | Week 0 , Week 4, Week 8, Week 12 |
| Change in serum total cholesterol (TC) concentration before and after intervention | Detected by enzyme-linked immunosorbent assay (ELISA) | Week 0 and Week 12 |
| Change in low-density lipoprotein (LDL) concentration before and after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The School of Food and Bioengineering, Henan University of Science and Technolog | Luoyang | Henan | 471000 | China |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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| Placebo | Dietary Supplement | The trial phase of this study lasted 12 weeks, and each patient will make 4 visits (week 0, week 4, week 8, week 12) |
|
Detected by enzyme-linked immunosorbent assay (ELISA) |
| Week 0 and Week 12 |
| Change in high-density lipoprotein (HDL) concentration before and after intervention | Detected by enzyme-linked immunosorbent assay (ELISA) | Week 0 and Week 12 |
| Change in triglyceride (TG) concentration before and after intervention. | Detected by enzyme-linked immunosorbent assay (ELISA) | Week 0 and Week 12 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |