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| Name | Class |
|---|---|
| Federico II University | OTHER |
Randomized, single-blind, trial to determine whether a high-protein, low calorie diet is more effective than a control low calorie diet in improving the metabolic and histologic abnormalities in patients with Non-alcoholic Fatty Liver Disease undergoing bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-protein low calorie diet (HPLC) | Active Comparator | 900 Kcal; Protein 90 g (39%); CHO 75 g (30%); Lipid 32 g (31%) |
|
| Control low calorie diet (CLC) | Placebo Comparator | 900 Kcal; Protein. 50 g (22%); CHO 119 g (48%); Lipid 31 g (30%) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High-protein low calorie diet | Dietary Supplement |
| ||
| Control low calorie diet |
| Measure | Description | Time Frame |
|---|---|---|
| Liver fat content assessment | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity assessment | 1 year | |
| fat free mass assessment | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Geltrude Mingrone, Professor | Contact | 0630154395 | 0039 | gmingrone@rm.unicatt.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Catholic University School of Medicine | Rome | 00168 | Italy |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D001823 | Body Composition |
| D055442 | Metabolome |
| ID | Term |
|---|---|
| D001669 | Biochemical Phenomena |
| D055598 | Chemical Phenomena |
| D008660 | Metabolism |
| D001824 | Body Constitution |
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| Dietary Supplement |
|
| Anthropometrical measurements | Other |
|
| Body composition | Other |
|
| 8-h metabolic profile | Other |
|
| Liver biopsy | Other |
|
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D010829 |
| Physiological Phenomena |