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 2019More...
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
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