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

National Nutrition and Food Technology Institute

Status and phase: Completed; Phase 3; Phase 2

Conditions: Type 2 Diabetes Nonalcoholic Fatty Liver

Treatments: Dietary Supplement: caffeine and chlorogenic acid; Dietary Supplement: placebo; Dietary Supplement: chlorogenic acid; Dietary Supplement: caffeine

Study type: Interventional

Funder types: Other

Identifiers

NCT02929901

147

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 30 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

caffeine and chlorogeinc acid

Active Comparator group

Description:

caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months

Treatment:

Dietary Supplement: caffeine and chlorogenic acid

caffeine

Active Comparator group

Description:

caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months

Treatment:

Dietary Supplement: caffeine

chlorogenic acid

Active Comparator group

Description:

chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months

Treatment:

Dietary Supplement: chlorogenic acid

placebo

Placebo Comparator group

Description:

placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months

Treatment:

Dietary Supplement: placebo