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OpenTrials
Completed

NCT Number: NCT02929901

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

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.

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Key information

Age range

30 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

NNFTRI clinic

Tehran, 19435, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

caffeine and chlorogenic acid

Dietary Supplement

caffeine plus chlorogenic acid

Caffeine

Dietary Supplement

caffeine plus placebo

chlorogenic acid

Dietary Supplement

chlorogenic acid plus placebo

Placebo

Dietary Supplement

placebo plus placebo

Primary outcomes

  1. Hepatic steatosis

    Time frame: 6 months

    measured by CAP score using Fibroscan

Secondary outcomes

  1. Glucose

    Time frame: 6 months

  2. Glycated hemoglobin (HBA1C)

    Time frame: 6 months

  3. alanine aminotransferase (ALT)

    Time frame: 6 months

  4. aspartate aminotransferase (ALS)

    Time frame: 6 months

  5. High sensitive C reactive protein ( hs- CRP)

    Time frame: 6 months

  6. gut microbiota

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

National Nutrition and Food Technology Institute

Other

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Oct 11, 2016
Registry last updated
May 1, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.