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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

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ClinicalTrials.gov Identifier: NCT02929901
Recruitment Status : Unknown
Verified October 2016 by Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute.
Recruitment status was:  Not yet recruiting
First Posted : October 11, 2016
Last Update Posted : October 18, 2016
Sponsor:
Information provided by (Responsible Party):
Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute

Brief Summary:
The purpose of this study is to investigate the effects of coffee main constituents (caffeine and chlorogenic acid) supplements on inflammatory, metabolic factors, hepatic steatosis and fibrosis in none- alcoholic fatty liver patients with type 2 diabetes. Two hundred patients with fatty liver and type 2 diabetes will be randomly assigned to one of four groups: group 1, caffeine (200 mg/d) plus chlorogenic acid (200 mg/d); group 2, caffeine (200 mg/d) plus placebo; group 3, chlorogenic acid (200 mg/d) plus placebo; group 4, placebo plus placebo. Supplementation will be daily and will supervise for 6 months.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Nonalcoholic Fatty Liver Dietary Supplement: caffeine and chlorogenic acid Dietary Supplement: caffeine Dietary Supplement: chlorogenic acid Dietary Supplement: placebo Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Study Start Date : December 2016
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : December 2017


Arm Intervention/treatment
Active Comparator: caffeine and chlorogeinc acid
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
Dietary Supplement: caffeine and chlorogenic acid
caffeine plus chlorogenic acid

Active Comparator: caffeine
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
Dietary Supplement: caffeine
caffeine plus placebo

Active Comparator: chlorogenic acid
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Dietary Supplement: chlorogenic acid
chlorogenic acid plus placebo

Placebo Comparator: placebo
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Dietary Supplement: placebo
placebo plus placebo




Primary Outcome Measures :
  1. Hepatic steatosis [ Time Frame: 6 months ]
    measured by CAP score using Fibroscan


Secondary Outcome Measures :
  1. Glucose [ Time Frame: 6 months ]
  2. Glycated hemoglobin (HBA1C) [ Time Frame: 6 months ]
  3. alanine aminotransferase (ALT) [ Time Frame: 6 months ]
  4. aspartate aminotransferase (ALS) [ Time Frame: 6 months ]
  5. High sensitive C reactive protein ( hs- CRP) [ Time Frame: 6 months ]


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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02929901


Locations
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Iran, Islamic Republic of
NNFTRI clinic
Tehran, Iran, Islamic Republic of, 19435
Sponsors and Collaborators
National Nutrition and Food Technology Institute

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Responsible Party: Dr Azita Hekmatdoost, National Nutrition and Food Technology Institute
ClinicalTrials.gov Identifier: NCT02929901     History of Changes
Other Study ID Numbers: 147
First Posted: October 11, 2016    Key Record Dates
Last Update Posted: October 18, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Fatty Liver
Non-alcoholic Fatty Liver Disease
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Liver Diseases
Digestive System Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents