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The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| caffeine and chlorogeinc acid | Active Comparator | caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months |
|
| caffeine | Active Comparator | caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months |
|
| chlorogenic acid | Active Comparator | chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months |
|
| placebo | Placebo Comparator | placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| caffeine and chlorogenic acid | Dietary Supplement | caffeine plus chlorogenic acid |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hepatic steatosis | measured by CAP score using Fibroscan | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose | 6 months | |
| Glycated hemoglobin (HBA1C) | 6 months | |
| alanine aminotransferase (ALT) |
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Inclusion Criteria:
Exclusion Criteria:
Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NNFTRI clinic | Tehran | 19435 | Iran |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32256270 | Derived | Mansour A, Mohajeri-Tehrani MR, Karimi S, Sanginabadi M, Poustchi H, Enayati S, Asgarbeik S, Nasrollahzadeh J, Hekmatdoost A. Short term effects of coffee components consumption on gut microbiota in patients with non-alcoholic fatty liver and diabetes: A pilot randomized placebo-controlled, clinical trial. EXCLI J. 2020 Mar 2;19:241-250. doi: 10.17179/excli2019-2021. eCollection 2020. |
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| caffeine | Dietary Supplement | caffeine plus placebo |
|
| chlorogenic acid | Dietary Supplement | chlorogenic acid plus placebo |
|
| placebo | Dietary Supplement | placebo plus placebo |
|
| 6 months |
| aspartate aminotransferase (ALS) | 6 months |
| High sensitive C reactive protein ( hs- CRP) | 6 months |
| gut microbiota | 3 months |
| ID | Term |
|---|---|
| D002110 | Caffeine |
| D002726 | Chlorogenic Acid |
| ID | Term |
|---|---|
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D011688 | Purinones |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002934 | Cinnamates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D003509 | Cyclohexanecarboxylic Acids |
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