Comparison of resveratrol supplementation, calorie restriction diet and placebo on nutritional status, metabolic and oxidative parameters, serum sirtuin-1 and fibroblast growth factor-21 levels in patients with nonalcoholic fatty liver disease
The aim of this study is to investigate the effects of resveratrol supplementation compared with calorie restriction diet on nutritional status, metabolic and oxidative parameters, serum sirtuin-1 and fibroblast growth factor-21 levels in patients with nonalcoholic fatty liver disease. Eighty-seven patients will randomly be divided in to 3 intervention groups including: resveratrol group (receive 2 capsules each containing 300 mg trans resveratrol); calorie restriction diet group (receive a prescribed diet for the purpose of losing maximum 10 percent of their initial body weight); placebo group: (receive 2 capsules each containing 300 mg starch) for 12 weeks. Researcher and patients are blinded in resveratrol and placebo groups. BMI, age and sex will be matched in 3 groups. All patients will receive basic education about principles of healthy eating. At the baseline and the end of the intervention, biochemical indices, anthropometric and blood pressure measurements will be assessed and compared between groups. Three-day food record questionnaires and physical activity questionnaire will be fulfilled at baseline, after 6 weeks and end of the intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511233664N16
Registration date:2016-02-08, 1394/11/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-08, 1394/11/19
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
Nutrition Research Center, Vice-chancellor of Tabriz University of Medical Sciences.
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-04, 1395/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of resveratrol supplementation, calorie restriction diet and placebo on nutritional status, metabolic and oxidative parameters, serum sirtuin-1 and fibroblast growth factor-21 levels in patients with nonalcoholic fatty liver disease
Public title
Comparison of resveratrol supplementation and calorie restriction diet effects on nutritional and metabolic status in patients with nonalcoholic fatty liver disease
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age between 20 to 60 years from both gender; diagnosed with nonalcoholic fatty liver disease based on liver Ultrasonography; BMI=25-35; willingness to participate in the study.
Exclusion criteria: pregnancy; breast feeding and postmenopausal women; professional athletes; smoking; alcohol consumption; following weight-reducing diet 3 months prior to the study; known liver disease (viral/etc.); inherited disorders affecting the liver; history of diagnosed cardiovascular, kidney, diabetes, gastrointestinal, pulmonary and autoimmune diseases, thyroid dysfunction and active cancer; recent surgery; use of medications such as corticosteroids, hepatotoxic drugs, hormonal drugs (such as oral contraceptive and/or estrogens), antidepressants and psychotropic medications, anticoagulant drugs, oral anti-diabetic and lipid-lowering drugs. Receiving any kinds of supplements 3 months prior to the study.
Age
From 18 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
87
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
This study is partially blinded. The intervention for resveratrol and placebo groups is indistinguishable for study subjects in those two groups. Randomization was carried out using a random allocation software (RAS).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street