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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

NCT02929901 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-05-01

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Nonalcoholic Fatty Liver

Interventions

DIETARY_SUPPLEMENT

caffeine and chlorogenic acid

caffeine plus chlorogenic acid

DIETARY_SUPPLEMENT

caffeine

caffeine plus placebo

DIETARY_SUPPLEMENT

chlorogenic acid

chlorogenic acid plus placebo

DIETARY_SUPPLEMENT

placebo

placebo plus placebo

Sponsors & Collaborators

  • National Nutrition and Food Technology Institute

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-31
Primary Completion
2018-09-30
Completion
2019-03-31

Countries

  • Iran

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02929901 on ClinicalTrials.gov