Clinical Trial: 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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title:

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 Summary:
Sponsor: National Nutrition and Food Technology Institute

Current Primary Outcome: Hepatic steatosis [ Time Frame: 6 months ]

measured by CAP score using Fibroscan


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Glucose [ Time Frame: 6 months ]
  • Glycated hemoglobin (HBA1C) [ Time Frame: 6 months ]
  • alanine aminotransferase (ALT) [ Time Frame: 6 months ]
  • aspartate aminotransferase (ALS) [ Time Frame: 6 months ]
  • High sensitive C reactive protein ( hs- CRP) [ Time Frame: 6 months ]


Original Secondary Outcome:

  • Glucose [ Time Frame: 6 months ]
  • HBA1C [ Time Frame: 6 months ]
  • ALT [ Time Frame: 6 months ]
  • ALS [ Time Frame: 6 months ]
  • High sensitive C reactive protein ( hs- CRP) [ Time Frame: 6 months ]


Information By: National Nutrition and Food Technology Institute

Dates:
Date Received: October 9, 2016
Date Started: December 2016
Date Completion: December 2017
Last Updated: October 14, 2016
Last Verified: October 2016