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
• Interventions: Dietary Supplement: chlorogenic acid; Dietary Supplement: caffeine and chlorogenic acid; Dietary Supplement: placebo; Dietary Supplement: caffeine

• 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

Study Timeline

• Study First Submitted: 2016-10-09
• Study First Submitted QC: 2016-10-09
• Study First Posted: 2016-10-11
• Study Start: 2016-12
• Primary Completion: 2018-09
• Study Completion: 2019-03
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-28
• Last Update Posted: 2019-05-01

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

Arm && Interventions

Group	Intervention	Description
chlorogenic acid	chlorogenic acid	chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
caffeine and chlorogeinc acid	caffeine and chlorogenic acid	caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
placebo	placebo	placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
caffeine	caffeine	caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months

Primary Outcome Measures

Name	Time	Method
Hepatic steatosis	6 months	measured by CAP score using Fibroscan

Secondary Outcome Measures

Name	Time	Method
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
Glucose	6 months

Trial Locations

Locations (1)

NNFTRI clinic; 🇮🇷 Tehran, Iran, Islamic Republic of