Type 2 Diabetes Nonalcoholic Fatty Liver
Conditions
Brief summary
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.
Interventions
DIETARY_SUPPLEMENTcaffeine and chlorogenic acid
caffeine plus chlorogenic acid
DIETARY_SUPPLEMENTcaffeine
caffeine plus placebo
DIETARY_SUPPLEMENTchlorogenic acid
chlorogenic acid plus placebo
DIETARY_SUPPLEMENTplacebo
placebo plus placebo
Sponsors
National Nutrition and Food Technology Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Patient diagnosed with type 2 diabetes based on American Diabetes Association (ADA) definition or who only take oral antidiabetic drug. * CAPscore \>263
Exclusion criteria
* Criteria: * Taking any kind of antibiotics two weeks before recruitment; * History of alcohol consumption ; * pregnancy or lactation; * Professional athletes; * Other liver disease (viral/etc); * High dose synthetic estrogens, methotrexate , amiodarone, steroids, chloroquine, immunosuppressive drugs; * A history of Cardiovascular disease; * Renal disease, Celiac disease, Cirrhosis; * History of Upper Gastrointestinal surgery ; * A history of hypothyroidism or Cushing's syndrome; * History of drug dependence; * Body mass index (BMI) ≥35 kg/m2; * A restrictive diet or weight change ≥ 5 kg during the 3 months prior to study; * Any change in treatment with oral hypoglycemic; anti hypertensive and antilipid agents during the study; * Use of weight loss medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hepatic steatosis | 6 months | measured by CAP score using Fibroscan |
Secondary
| Measure | Time frame |
|---|---|
| Glycated hemoglobin (HBA1C) | 6 months |
| alanine aminotransferase (ALT) | 6 months |
| Glucose | 6 months |
| High sensitive C reactive protein ( hs- CRP) | 6 months |
| gut microbiota | 3 months |
| aspartate aminotransferase (ALS) | 6 months |
Countries
Iran
Outcome results
None listed