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To assess the efficacy and safety of the use of probiotics as a food supplement compared to placebo in regulating body metabolism and gut microbiota in overweight or obese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | Each Akk11 capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio), together with 1 × 10¹⁰ AFU of viable Akk11 cells. Dosage: 3 capsules per day. |
|
| Placebo group | Placebo Comparator | Each placebo capsule contained 350 mg inulin and 175 mg FOS (2:1 ratio). Dosage: 3 capsules per day. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The trial phase of this study lasted 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in serum concentrations of glucagon-like peptide-1 (GLP-1) before and after intervention. | Detected by enzyme-linked immunosorbent assay (ELISA). | week 0 and week 8 |
| Changes in serum concentrations of leptin before and after intervention. | Detected by enzyme-linked immunosorbent assay (ELISA). | week 0 and week 8 |
| Changes in serum concentrations of peptide YY before and after intervention. | Detected by enzyme-linked immunosorbent assay (ELISA). | week 0 and week 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fei Xu | Zhengzhou | None Selected | 210095 | China |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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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 8 weeks, and each patient will make 3 visits (week 0, week 4, week 8) |
|
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019602 |
| Food and Beverages |