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Obesity is closely related to many chronic diseases such as hypertension, coronary heart disease, hyperlipidemia, type 2 diabetes, fatty liver, certain types of tumors, etc, which are associated with adverse health outcomes. Limiting energy intake is one of the most important treatment measures for weight loss. The fruits of Aronia melanocarpa (Aronia berries) have been found to show multiple bioactivities potentially beneficial to human health, including antidiabetic, anti-infective, antineoplastic, antiobesity, antioxidant and gut microbiota-regulating activities. Thus, it is worth investigating whether consumption of aronia melanocarpa extract have additional benefits in improving anthropometric indicators, glucose and lipid metabolism, inflammatory status, adipocyte cytokines, and intestinal microbiota in obese individuals on the basis of an energy-restricted diet.
Obese individuals will be divided into intervention group and control group in this 8-week trial. Both groups will be given an energy-restricted diet, with an additional dose of aronia melanocarpa extract in capsules in intervention group and an additional dose of maltodextrin in capsules in control group.
Fecal and blood samples from participants before and after the intervention will be collected for the analysis of gut microbiota, glucose and lipid metabolism, inflammatory status, and adipocyte cytokines
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | Intervention group: an energy-restricted diet + aronia melanocarpa extract |
|
| Control group | Placebo Comparator | control group: an energy-restricted diet + maltodextrin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| aronia melanocarpa extract | Dietary Supplement | aronia melanocarpa extract (each capsule contains 150 mg of anthocyanins and 30 mg of flavonoidst;twice a day,one at a time) combined with an energy-restricted diet |
| Measure | Description | Time Frame |
|---|---|---|
| gut microbiota | High flux sequencing of fecal specimens | 8 weeks |
| glucose metabolism | Fasting blood glucose (in mmol/L) | 8 weeks |
| glucose metabolism | fasting insulin (in μIU/L) | 8 weeks |
| glucose metabolism | glycosylated hemoglobin (in %) | 8 weeks |
| lipid metabolism | total cholesterol (in mmol/L) | 8 weeks |
| lipid metabolism | triglycerides (in mmol/L) | 8 weeks |
| lipid metabolism | high-density lipoprotein cholesterol (in mmol/L) | 8 weeks |
| lipid metabolism | low-density lipoprotein cholesterol (in mmol/L) | 8 weeks |
| leptin | serum leptin (in ng/ml) | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Anthropometrics | Body weight (in kg) | 8 weeks |
| Anthropometrics | waist circumference (in cm) | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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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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| adiponectin |
serum adiponectin (in μg/ml) |
| 8 weeks |
| Inflammatory cytokine | serum interleukin-1 (in pg/mL) | 8 weeks |
| Inflammatory cytokine | serum interleukin-6 (in ng/L) | 8 weeks |
| Inflammatory cytokine | tumor necrosis factor-α (in pg/ml) | 8 weeks |
| Inflammatory cytokine | hypersensitive C-reactive protein (in mg/L) | 8 weeks |
| Anthropometrics | BMI in kg/m^2 | 8 weeks |
| body composition | including body fat (in %), fat-free mass (in kg) | 8 weeks |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |