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| Name | Class |
|---|---|
| University of Pavia | OTHER |
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Menopause is usually associated with an increase in body weight, a change in body composition and fat distribution and a large number of cardio-metabolic changes, such as hypertension, reduction of insulin-sensitivity and dyslipidaemia. The first-line strategy for these complications is the modification of dietary habits and lifestyle in terms of physical activity. Besides, there is also a growing interest in complementary therapies (i.e. nutraceuticals) that can be used alone or in combination to achieve more consistent results. In this context, preliminary evidence supports the potential role of some compounds of vegetal origin such as berberine, chlorogenic acid and tocotrienols. However, in support of their use, the evidence from good quality trials is limited.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nutraceutical | Experimental | Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid |
|
| Control | Active Comparator | Nutritional counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nutraceutical | Dietary Supplement | Nutritional counseling plus one pill of an active product (Trixy®) containing Berberine, Tocotrienols and Chlorogenic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| LDL cholesterol | LDL cholesterol | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin resistance | Homeostatic model assessment (HOMA index) | 3 months |
| Total cholesterol | Total cholesterol | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione IRCCS Policlinico San Matteo | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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| Control | Other | Nutritional counseling |
|
| HDL cholesterol | HDL cholesterol | 3 months |
| Blood glucose | Blood glucose | 3 months |
| Serum Insulin | Serum Insulin | 3 months |
| Body weight | Body weight | 3 months |
| Fat distribution | Waist circumference | 3 months |
| Fat Mass | Fat Mass | 3 months |
| Menopausal symptoms | Greene Climacteric Scale | 3 months |
| Quality of life | 36-Item Short Form Health Survey (SF-36) | 3 months |