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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

Primary Purpose

Type 2 Diabetes Nonalcoholic Fatty Liver

Status
Completed
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
caffeine and chlorogenic acid
caffeine
chlorogenic acid
placebo
Sponsored by
National Nutrition and Food Technology Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Nonalcoholic Fatty Liver

Eligibility Criteria

30 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • NNFTRI clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

caffeine and chlorogeinc acid

caffeine

chlorogenic acid

placebo

Arm Description

caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months

caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months

chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months

placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months

Outcomes

Primary Outcome Measures

Hepatic steatosis
measured by CAP score using Fibroscan

Secondary Outcome Measures

Glucose
Glycated hemoglobin (HBA1C)
alanine aminotransferase (ALT)
aspartate aminotransferase (ALS)
High sensitive C reactive protein ( hs- CRP)
gut microbiota

Full Information

First Posted
October 9, 2016
Last Updated
April 28, 2019
Sponsor
National Nutrition and Food Technology Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02929901
Brief 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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
March 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Nutrition and Food Technology Institute

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Nonalcoholic Fatty Liver

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
caffeine and chlorogeinc acid
Arm Type
Active Comparator
Arm Description
caffeine (200 mg) 1 capsule / day for 6 months plus chlorogenic acid (200 mg) 1 capsule / day for 6 months
Arm Title
caffeine
Arm Type
Active Comparator
Arm Description
caffeine (200 mg) 1 capsule / day for 6 months plus placebo (200) mg 1 capsule / day for 6 months
Arm Title
chlorogenic acid
Arm Type
Active Comparator
Arm Description
chlorogenic acid (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo (200 mg) 1 capsule / day for 6 months plus placebo (200 mg) 1 capsule / day for 6 months
Intervention Type
Dietary Supplement
Intervention Name(s)
caffeine and chlorogenic acid
Intervention Description
caffeine plus chlorogenic acid
Intervention Type
Dietary Supplement
Intervention Name(s)
caffeine
Intervention Description
caffeine plus placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
chlorogenic acid
Intervention Description
chlorogenic acid plus placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Intervention Description
placebo plus placebo
Primary Outcome Measure Information:
Title
Hepatic steatosis
Description
measured by CAP score using Fibroscan
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Glucose
Time Frame
6 months
Title
Glycated hemoglobin (HBA1C)
Time Frame
6 months
Title
alanine aminotransferase (ALT)
Time Frame
6 months
Title
aspartate aminotransferase (ALS)
Time Frame
6 months
Title
High sensitive C reactive protein ( hs- CRP)
Time Frame
6 months
Title
gut microbiota
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
NNFTRI clinic
City
Tehran
ZIP/Postal Code
19435
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
32256270
Citation
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.
Results Reference
derived

Learn more about this trial

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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