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This study intends to study the effect of Akkermansia muciniphila on weight loss and the improvement of blood inflammation and metabolic indexes in obese patients with low Body Mass Index (BMI) through multi-center clinical studies, and for the first time to innovatively explore the weight loss mechanism of Akkermansia muciniphila by comparing the changes in brain function and fecal microbiota before and after intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic group | Experimental | 10B AFU/four capsules/day Akk11, before meals; Storage: store in a cool, dry place without sun exposure. |
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| Placebo group | Placebo Comparator | Four maltodextrin capsules/day, before meals; Storage: store in a cool, dry place without sun exposure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic | Dietary Supplement | The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Mass Index(BMI) | BMI = Weight (kg) / [Height (m)]². 24kg/m² ≤ BMI < 28 kg/m² is in the overweight range, and BMI ≥ 28 kg/m² is in the obesity range. | Day 0, week4, week8, week12. |
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Inclusion Criteria:
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1) Age 18-65 years old; 2)28≤BMI≤35Kg/m2; 3) Willing and able to comply with the protocol during the study period, and be able to cooperate with the completion of various examinations during the trial. Written informed consent is provided prior to entry into study screening, and the patient has understood that the study can be withdrawn at any time from the study without any loss
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiangpeng Wei, Doctor | The First Affiliated Hospital, the Air Force Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, the Air Force Medical University | Xi'an | Shaanxi | 710032 | China |
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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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Double(participant, investigator)
| Placebo | Dietary Supplement | The trial phase of the study will last 12 weeks and each subject will make 4 follow-up visits (day 0, week 4, week 8 and week 12). |
|
| D019602 |
| Food and Beverages |