Effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease
Object of study: investigation of the effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease (NAFLD).
Study design: Random, double blind, Control with Placebo.
Study population: Patients with NAFLD will be randomly divided into 2 intervention groups:1. green coffee extract recipient group (a capsule 200 mg, after breakfast and one number after lunch) 2. Placebo group (a Placebo capsule containing 200 mg starch after breakfast and one number after lunch). The main criteria for inclusion: 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 kilogram per square mete. Main exclusion criteria: alcohol intake; pregnancy; lactation and menopause; liver transplantation; other diagnosis; cancer; Inherited disorders affecting the liver status; hepatotoxic drugs consumption; anticoagulant; vitamins supplements.
Sample size: 48 persons (2 groups of 24 people). (B) Intervention or interventions studied: two group: 1. green coffee extract recipient group 2. Placebo group (c) intervention time: 8 weeks. (D) The primary outcome of the study: The impact of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements. Secondary outcomes of the study: The impact of supplement usage on blood pressure.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201602113664N17
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Student research center of Tabriz University of Medical Sciences
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-09-05, 1395/06/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of green coffee extract supplementation on metabolic status, serum leptin level and anthropometric measurements in patients with non-alcoholic fatty liver disease
Public title
The effect of green coffee extract in the treatment of non-alcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
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 kilogram per Square meters.
Exclusion criteria of study: Alcohol intake; Gestation; Lactation and Menopause; Loss Weight Diet; Anemia; Very active or Athlete; history or current diagnosis of Cardiovascular disease; history or current diagnosis of Gastrointestinal disease and Diabetes; history or current diagnosis of Pulmonary disease; history or current diagnosis of Renal disease; Liver transplantation and other liver diseases and chronic or acute liver disease (Hepatitis A, B, ...); Biliary impairments; Biliary Stone or Kidney Stone; Autoimmune disease; Cancers; Inherited disorders affecting liver condition; Consumption drugs hepatotoxic; Anticoagulant; Vitamins supplement such as A, E, C and omega3; Estrogen and Oral Contraceptive drugs.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Science
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz, East Azerbaijan
Intervention Group: Intake of Green coffee extract 200 mg capsules two times a day, Prepared by Bonian Salamat Kasra company, for 8 weeks.
Category
Treatment - Drugs
2
Description
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.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital
Full name of responsible person
Samaneh Hosseinabadi
Street address
Imam Khomeini Ave, Iran Sq, Neyshabor
City
Neyshabor
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr Alirza Ostadrahimi
Street address
Tabriz University of Medical Sciences, Golgasht Ave, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Hosseinabadi
Position
MSc Student of Nutrition Sciences
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
saman7347@gmail.cm
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Hosseinabadi
Position
MSc Student of Nutrition Sciences
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
saman7347@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Nutrition and Food Sciencs Faculty, Tabriz University of Medical Sciences
Full name of responsible person
Samaneh Hosseinabadi
Position
MSc Student of Nutrition Sciences
Other areas of specialty/work
Street address
Nutrition and Food Sciences Faculty, Tabriz University of Medical Sciences, Attar Neyshabori Street, Golgasht Ave, Tabriz
City
Tabriz
Postal code
5166614711
Phone
+98 41 3335 7581
Fax
+98 41 3334 0634
Email
saman7347@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)