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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02929901
• Date of registration: 09/10/2016
• Prospective Registration: Yes
• Primary sponsor: National Nutrition and Food Technology Institute
• Public title: 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
• Date of first enrolment: December 2016
• Target sample size: 200
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02929901
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2/Phase 3

Countries of recruitment

Iran, Islamic Republic of

Key inclusion & exclusion criteria

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



Age minimum: 30 Years
Age maximum: 65 Years
Gender: All

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Nonalcoholic Fatty Liver

Intervention(s)

Dietary Supplement: chlorogenic acid

Dietary Supplement: caffeine

Dietary Supplement: caffeine and chlorogenic acid

Dietary Supplement: placebo

Primary Outcome(s)

Hepatic steatosis [Time Frame: 6 months]

Secondary Outcome(s)

alanine aminotransferase (ALT) [Time Frame: 6 months]

Glycated hemoglobin (HBA1C) [Time Frame: 6 months]

gut microbiota [Time Frame: 3 months]

aspartate aminotransferase (ALS) [Time Frame: 6 months]

Glucose [Time Frame: 6 months]

High sensitive C reactive protein ( hs- CRP) [Time Frame: 6 months]

Secondary ID(s)

147

Source(s) of Monetary Support

Please refer to primary and secondary sponsors