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Effects of Supplementation with Main Coffee Components on Hepatic, Metabolic, and Inflammatory Indices in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial

33 Pages Posted: 3 Jun 2019

See all articles by Asieh Mansour

Asieh Mansour

Shahid Beheshti University of Medical Sciences - Department of Clinical Nutrition & Dietetics

Mohammad Reza Mohajeri-Tehrani

Tehran University of Medical Sciences

Majid Samadi

Tehran University of Medical Sciences

Mostafa Qorbani

Alborz University of Medical Sciences

Shahin Merat

Tehran University of Medical Sciences - Liver and Pancreatobiliary Diseases Research Center

Hossein Adibi

Tehran University of Medical Sciences - Endocrinology and Metabolism Clinical Sciences Institute

Hossein Poustchi

Tehran University of Medical Sciences - Liver and Pancreatobiliary Diseases Research Center

Azita Hekmatdoost

Shahid Beheshti University of Medical Sciences - Department of Clinical Nutrition & Dietetics

More...

Abstract

Background: Coexistence of type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) leads to increase in the risk of both hepatic and diabetes' complications. The published epidemiological data demonstrating beneficial associations between all categories of coffee exposure and ranges of liver outcomes are rapidly growing; however, the main contributors and cause-effect relationships have not yet been elucidated. To address existing knowledge gaps, we sought to determine the efficacy and safety of 6 months chlorogenic acid and/or caffeine supplementation in type 2 diabetes patients affected by NAFLD.

Methods: This randomized, double-blind, placebo-controlled trial was carried out at two Diabetes Centers to assess the effects of supplementation with daily doses of 200 mg chlorogenic acid , 200 mg caffeine, 200 mg chlorogenic acid plus 200 mg caffeine or placebo in type 2 diabetes patients with NAFLD. The primary endpoint was reduction of hepatic fat and stiffness measured by FibroScan; as hepatic outcomes, we also investigated changes in serum hepatic enzymes and cytokeratin -18 (CK-18) levels. Secondary endpoints were improvement in metabolic and inflammatory parameters from baseline to the end of treatment.

Results: Neither chlorogenic acid nor caffeine was superior to placebo in attaining the hepatic fat and stiffness and other hepatic outcomes in patients with diabetes and NAFLD. Except for the lower level of total cholesterol in caffeine group (p=0.04) and higher level of insulin in chlorogenic acid plus caffeine group (p=0.01) compared with placebo, there were no significant differences among the treatment groups.

Conclusion: Our findings showed that 200 mg/day consumption of neither caffeine nor chlorogenic acids nor their combination is superior to placebo in management of NAFLD in type 2 diabetic patients. Further trials with higher dosages, longer duration, and different active components of coffee are highly recommended.

Trial Registration: This trial was registered at irct.ir, with registration number of number IRCT201707024010N21.

Funding Statement: This study was supported by the National Institute for Medical Research Developments, and by National Nutrition and Food Technology Research Institute, Shahid Beheshti of Medical Sciences, Tehran, Iran. We are also thanks to the patients who participated in the study.

Declaration of Interests: None of the authors have any conflicts of interest or financial ties to disclose.

Ethics Approval Statement: The protocol was approved by the National Institute for Medical Research Developments Ethics Committee and all participants provided written informed consent.

Keywords: Coffee; Caffeine; Chlorogenc acid; Type 2 Diabetes; NAFLD; Non- alcoholic fatty liver disease; Clinical trial

Suggested Citation

Mansour, Asieh and Mohajeri-Tehrani, Mohammad Reza and Samadi, Majid and Qorbani, Mostafa and Merat, Shahin and Adibi, Hossein and Poustchi, Hossein and Hekmatdoost, Azita, Effects of Supplementation with Main Coffee Components on Hepatic, Metabolic, and Inflammatory Indices in Patients with Non-Alcoholic Fatty Liver Disease and Type 2 Diabetes: A Randomized, Double-Blind, Placebo-Controlled, Clinical Trial (May 31, 2019). Available at SSRN: https://ssrn.com/abstract=3397199

Asieh Mansour (Contact Author)

Shahid Beheshti University of Medical Sciences - Department of Clinical Nutrition & Dietetics

Tehran
Iran

Mohammad Reza Mohajeri-Tehrani

Tehran University of Medical Sciences

Number 21, Dameshg St.
Vali-e Asr Ave.
Tehran, 14195
Iran

Majid Samadi

Tehran University of Medical Sciences

Number 21, Dameshg St.
Vali-e Asr Ave.
Tehran, 14195
Iran

Mostafa Qorbani

Alborz University of Medical Sciences

Iran

Shahin Merat

Tehran University of Medical Sciences - Liver and Pancreatobiliary Diseases Research Center ( email )

Number 21, Dameshg St.
Vali-e Asr Ave.
Tehran, 14195
Iran

Hossein Adibi

Tehran University of Medical Sciences - Endocrinology and Metabolism Clinical Sciences Institute

United States

Hossein Poustchi

Tehran University of Medical Sciences - Liver and Pancreatobiliary Diseases Research Center

Number 21, Dameshg St.
Vali-e Asr Ave.
Tehran, 14195
Iran

Azita Hekmatdoost

Shahid Beheshti University of Medical Sciences - Department of Clinical Nutrition & Dietetics ( email )

Tehran
Iran

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