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
NCT ID: NCT02929901
Last Updated: 2019-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2016-12-31
2019-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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caffeine and chlorogeinc acid
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
caffeine and chlorogenic acid
caffeine plus chlorogenic acid
caffeine
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
caffeine
caffeine plus placebo
chlorogenic acid
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
chlorogenic acid
chlorogenic acid plus placebo
placebo
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
placebo
placebo plus placebo
Interventions
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caffeine and chlorogenic acid
caffeine plus chlorogenic acid
caffeine
caffeine plus placebo
chlorogenic acid
chlorogenic acid plus placebo
placebo
placebo plus placebo
Eligibility Criteria
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Inclusion Criteria
* 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
30 Years
65 Years
ALL
No
Sponsors
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National Nutrition and Food Technology Institute
OTHER
Responsible Party
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Dr Azita Hekmatdoost
Dr Azita Hekmatdoost
Locations
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NNFTRI clinic
Tehran, , Iran
Countries
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References
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Mansour A, Mohajeri-Tehrani MR, Karimi S, Sanginabadi M, Poustchi H, Enayati S, Asgarbeik S, Nasrollahzadeh J, Hekmatdoost A. Short term effects of coffee components consumption on gut microbiota in patients with non-alcoholic fatty liver and diabetes: A pilot randomized placebo-controlled, clinical trial. EXCLI J. 2020 Mar 2;19:241-250. doi: 10.17179/excli2019-2021. eCollection 2020.
Other Identifiers
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147
Identifier Type: -
Identifier Source: org_study_id
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