Assessement of the effects of coffee main constituents in none- alcoholic fatty liver patients with type 2 diabetes

Assessement of 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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT201707024010N21

Enrollment

100

Registered

2017-09-15

Start date

2017-10-02

Completion date

Unknown

Last updated

2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

NAFLD. (Nonalcoholic fatty liver disease (NAFLD

Interventions

Intervention 1: caffeine (200 mg) 1 capsule/d plus placebo (200 mg) 1 capsule/d. Intervention 2: placebo (200 mg) 1 capsule/d plus chlorogenic acid (200 mg) 1 capsule/. Intervention 3: caffeine (200 m

Treatment - Other

Placebo

caffeine (200 mg) 1 capsule/d plus placebo (200 mg) 1 capsule/d

placebo (200 mg) 1 capsule/d plus chlorogenic acid (200 mg) 1 capsule/

caffeine (200 mg) 1 capsule/d plus chlorogenic acid (200 mg) 1 capsule/d

placebo (200 mg) 1 capsule/d plus placebo (200 mg) 1 capsule/d

Eligibility

Sex/Gender

All

Age

30 Years to 50 Years

Inclusion criteria

Inclusion 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: 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

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Liver fibrosis. Timepoint: Before and 24 weekes after the intervention. Method of measurement: fiberscan.;Glucose. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;Weight. Timepoint: Before and 24 weekes after the intervention. Method of measurement: kg.;AST. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;GGT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;ALT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;Liver Steatosis. Timepoint: Before and 6 weekes after the intervention. Method of measurement: ultrasonography.	—

Measure

Time frame

Liver fibrosis. Timepoint: Before and 24 weekes after the intervention. Method of measurement: fiberscan.;Glucose. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;Weight. Timepoint: Before and 24 weekes after the intervention. Method of measurement: kg.;AST. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;GGT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;ALT. Timepoint: Before and 24 weekes after the intervention. Method of measurement: U/L.;Liver Steatosis. Timepoint: Before and 6 weekes after the intervention. Method of measurement: ultrasonography.

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Secondary

Measure	Time frame
TG. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;TC. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;LDL-C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;HDL-C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;TNF-a. Timepoint: Before and 24 weekes after the intervention. Method of measurement: pg/ml.;Insulin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µU/mL.;C-peptide. Timepoint: Before and 24 weekes after the intervention. Method of measurement: ng /ml.;CRP. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/l.;HbA1C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: %.;TAC. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µg/l.;Cytokeratin 18. Timepoint: Before and 24 weekes after the intervention. Method of measurement: u/l.;NFK-B. Timepoint: Before and 24 weekes after the intervention. Method of measurement: -.;a2-Macroglobulin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/l.;Adiponectin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µg/ml.;Leptin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: ng /ml.;IFN-g. Timepoint: Before and 24 weekes after the intervention. Method of measurement: pg/ml.	—

Measure

Time frame

TG. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;TC. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;LDL-C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;HDL-C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/dl.;TNF-a. Timepoint: Before and 24 weekes after the intervention. Method of measurement: pg/ml.;Insulin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µU/mL.;C-peptide. Timepoint: Before and 24 weekes after the intervention. Method of measurement: ng /ml.;CRP. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/l.;HbA1C. Timepoint: Before and 24 weekes after the intervention. Method of measurement: %.;TAC. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µg/l.;Cytokeratin 18. Timepoint: Before and 24 weekes after the intervention. Method of measurement: u/l.;NFK-B. Timepoint: Before and 24 weekes after the intervention. Method of measurement: -.;a2-Macroglobulin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: mg/l.;Adiponectin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: µg/ml.;Leptin. Timepoint: Before and 24 weekes after the intervention. Method of measurement: ng /ml.;IFN-g. Timepoint: Before and 24 weekes after the intervention. Method of measurement: pg/ml.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactAsieh Mansour

Faculty of Nutrition and Food Technology, Shahid Beheshti University of Medical Science

asiehmansour@yahoo.com+98 21 8822 0071

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 23, 2026