Protocol summary
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Study aim
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Investigation of the effect of green coffee extract supplementation on metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
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Design
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A randomized, double-blind, placebo-controlled trial
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Settings and conduct
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48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). Subjects will be recruited from 22 Bahman poly-clinic in Neyshabur, Iran.
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Participants/Inclusion and exclusion criteria
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48 patients with NAFLD will be randomly divided into two intervention groups:1. green coffee extract recipient group (one 200 mg capsule after breakfast and one after lunch) 2. placebo group (a placebo capsule containing 200 mg starch after breakfast and one after lunch). The main criteria for inclusion are observing hepatic steatosis on ultrasound, age range 20-50 years for women and 20-60 years for men; body mass index (BMI) greater than 25 and less than 35 kilograms per square meter. The main exclusion criteria are alcohol intake; pregnancy, lactation, and menopause; liver transplantation; cancers; Inherited disorders affecting the liver status; consumption of hepatotoxic drugs, anticoagulants, and vitamin supplements.
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Intervention groups
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Group 1: green coffee extract recipient
Group 2: Placebo recipient
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Main outcome variables
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Metabolic and oxidative status, serum leptin and adiponectin levels and anthropometric measurements
General information
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Reason for update
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Adding new factors of supplementary research in this study
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201602113664N17
Registration date:
2016-04-08, 1395/01/20
Registration timing:
registered_while_recruiting
Last update:
2019-12-12, 1398/09/21
Update count:
1
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Registration date
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2016-04-08, 1395/01/20
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Student research center of Tabriz University of Medical Sciences
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Expected recruitment start date
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2016-04-03, 1395/01/15
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Expected recruitment end date
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2016-09-05, 1395/06/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease
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Public title
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The effect of green coffee extract in the treatment of non-alcoholic fatty liver disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Nonalcoholic fatty liver (observation of liver steatosis on Sonographic image)
The age range of 20-50 years in women and 20-60 years in men
Body mass index greater than 25 and less than 35 kilograms per Square meters
Exclusion criteria:
Alcohol intake
Gestation, Lactation, and Menopause
Following a weight reducing diet
Professional athletes
History or current diagnosis of anemia, cardiovascular disease; gastrointestinal disease, diabetes, pulmonary disease, renal disease, acute or chronic liver disorders (Hepatitis A, B, ...), biliary impairments, biliary or kidney stones; autoimmune disease, cancers, Inherited disorders affecting the liver, and other diseases
Use of medications such as hepatotoxic drugs, anticoagulant drugs, hormonal drugs (e.g., oral contraceptives and/or estrogen), and consuming dietary supplements such as vitamin A, E, C, and omega-3 three months prior to the study and/or during the study period.
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Age
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From 18 years old to 60 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
- Data and Safety Monitoring Board
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Sample size
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Target sample size:
48
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization was carried out using a block randomization procedure of size 4 and was stratified by age, sex, and BMI. Random allocation software (RAS)
was used for generating a random sequence.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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An independent person not involved in the study process prepared both green coffee extract and placebo bottles and labeled them as A or B. All of the supplement packs were identically provided. The patients and researchers were all blinded to the treatment assignment until the statistical analyses were completed.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2016-02-10, 1394/11/21
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Ethics committee reference number
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TBZMED.REC.1394.1031
2
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Ethics committee
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Approval date
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2019-11-24, 1398/09/03
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Ethics committee reference number
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IR.TBZMED.REC.1398.918
Health conditions studied
1
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Description of health condition studied
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Non-alcoholic fatty liver
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ICD-10 code
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K 76
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ICD-10 code description
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Fatty liver
Primary outcomes
1
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Description
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Fasting Blood sugar
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Timepoint
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Baseline and after the intervention
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Method of measurement
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Spectrophotometery
2
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Description
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Liver Enzymes (Alanine aminotransferase, Aspartate aminotransferase)
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Timepoint
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Baseline and after the intervention
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Method of measurement
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Spectrophotometery
3
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Description
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Serum leptin level
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Timepoint
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Baseline and after the intervention
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Method of measurement
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ELISA
4
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Description
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Liver Echogenicity
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Timepoint
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Baseline and after the intervention
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Method of measurement
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Liver sonography
5
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Description
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Body Mass Index
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Timepoint
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Baseline and after the intervention
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Method of measurement
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(weight/(Height)2),
6
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Description
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Insulin
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Timepoint
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Baseline and after the intervention
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Method of measurement
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ELISA
7
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Description
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Waist Circumference
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Timepoint
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Baseline and after the intervention
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Method of measurement
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Cm
8
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Description
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Serum adiponectin level
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Timepoint
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Baseline and after the intervention
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Method of measurement
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ELISA
9
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Description
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Oxidative status (TAC, MDA)
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Timepoint
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Baseline and after the intervention
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Method of measurement
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Biochemical
Secondary outcomes
1
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Description
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Systolic and diastolic blood pressure
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Timepoint
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Beginning and eighth week of the study
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Method of measurement
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By Mercury Barometer
Intervention groups
1
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Description
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Intervention Group: Intake of Green coffee extract 200 mg capsules two times a day, Prepared by Bonian Salamat Kasra company, for 8 weeks.
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Category
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Treatment - Drugs
2
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Description
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Placebo groups: Intake a Placebo capsule containing 200 mg of starch, which is similar to green coffee extract supplement in terms of dosage, color and size, twice a day for 8 weeks.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tabriz University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Not applicable
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Analytic Code
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Not applicable
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Data Dictionary
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Not applicable