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This was a double-blind, randomized, placebo-controlled clinical study aiming to assess the effect of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 on liver steatosis in individuals with NAFLD and metabolic syndrome
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Food for special medical purposes | Active Comparator | Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Food for special medical purposes with calcium butyrate, zinc gluconate and vitamin D3 | Dietary Supplement | Food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3 |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Fatty Liver Index | We evaluated the effect on Fatty Liver Index (FLI) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect on Hepatic Steatosis Index | We evaluated the effect on Hepatic Steatosis Index (HSI) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo | 3 months |
| Effect on Lipid Accumulation Product |
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Inclusion criteria:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Claudio Borghi | University of Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Bologna | Bologna | BO | 40138 | Italy |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D007333 | Insulin Resistance |
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| ID | Term |
|---|---|
| D005502 | Food |
| C030691 | gluconic acid |
| D002762 | Cholecalciferol |
| ID | Term |
|---|---|
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
| D002782 | Cholestenes |
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| Placebo | Other | Placebo |
|
We evaluated the effect on Lipid Accumulation Product (LAP) of 3-month assumption of a food for special medical purposes with functional release containing calcium butyrate, zinc gluconate and vitamin D3, compared to either baseline and placebo |
| 3 months |
| D006946 |
| Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D002776 |
| Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013261 | Sterols |
| D014807 | Vitamin D |
| D012632 | Secosteroids |
| D008563 | Membrane Lipids |
| D008055 | Lipids |