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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 200
- Locations
- 2
- Primary Endpoint
- Hepatic steatosis
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
caffeine and chlorogeinc acid
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
Intervention: caffeine and chlorogenic acid (Dietary Supplement)
caffeine
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
Intervention: caffeine (Dietary Supplement)
placebo
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Intervention: placebo (Dietary Supplement)
chlorogenic acid
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Intervention: chlorogenic acid (Dietary Supplement)
Outcomes
Primary Outcomes
Hepatic steatosis
Time Frame: 6 months
measured by CAP score using Fibroscan
Secondary Outcomes
- aspartate aminotransferase (ALS)(6 months)
- High sensitive C reactive protein ( hs- CRP)(6 months)
- gut microbiota(3 months)
- Glucose(6 months)
- Glycated hemoglobin (HBA1C)(6 months)
- alanine aminotransferase (ALT)(6 months)
Investigators
Dr Azita Hekmatdoost
Dr Azita Hekmatdoost
National Nutrition and Food Technology Institute