The Effects of Coffee Main Constituents (Caffeine and Chlorogenic Acid) Supplementation on Inflammatory, Metabolic Factors, Hepatic Steatosis and Fibrosis in None- Alcoholic Fatty Liver Patients With Type 2 Diabetes
Phase 2
Completed
- Conditions
- Type 2 Diabetes Nonalcoholic Fatty Liver
- Registration Number
- NCT02929901
- Lead Sponsor
- National Nutrition and Food Technology Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 200
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Hepatic steatosis 6 months measured by CAP score using Fibroscan
- Secondary Outcome Measures
Name Time Method Glucose 6 months Glycated hemoglobin (HBA1C) 6 months alanine aminotransferase (ALT) 6 months aspartate aminotransferase (ALS) 6 months High sensitive C reactive protein ( hs- CRP) 6 months gut microbiota 3 months
Trial Locations
- Locations (1)
NNFTRI clinic
🇮🇷Tehran, Iran, Islamic Republic of
NNFTRI clinic🇮🇷Tehran, Iran, Islamic Republic of