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Difficulties in enrollment and patient compliance
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The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No intervention | No Intervention | ||
| Experimental | Experimental | Dietary Supplement with inositols and alpha-lactalbumin |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inositol and alpha-lactalbumin | Dietary Supplement | The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Body weight | Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days |
| Measure | Description | Time Frame |
|---|---|---|
| Tryglicerides | Plasmatic levels of tryglicerides | Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days |
| Hypertension | sphygmomanometer |
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At least 3 of the following inclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Davide Grassi, MD | UOC Medicina Interna e Nefrologia P.O. AQ | Principal Investigator |
| Claudio Ferri, MD | UOC Medicina Interna e Nefrologia P.O. AQ | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UOC Medicina Interna e Nefrologia P.O. AQ | L’Aquila | Italy |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D007768 | Lactalbumin |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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| Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days |
| D009750 |
| Nutritional and Metabolic Diseases |
| D000418 |
| Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |