This randomized double blind placebo controlled trial design with aim to determine the effect of chlorella vulgaris supplementation on oxidative stress and inflammatory indices on non-alcoholic fatty liver disease (NAFLD) patients. 70 patients with NAFLD will be randomly divided into 2 intervention and placebo groups. Subjects in two intervention and placebo group will receive 4 tablets of chlorella vulgaris daily (each containing 300 mg, daily 1200 mg) or 4 tablets of placebo respectively for two month. For all of the participants, personality questionnaire and 3 dietary records (0,4.8 weeks) will be filled for assessment of nutrient intake and food frequency questionnaire for food habit evaluation. The anthropometric and biochemical measurements at first and end of the study will be repeated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202233320N7
Registration date:2012-05-04, 1391/02/15
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-05-04, 1391/02/15
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Nutritional Research Center, Health and Nutrition Faculty, Tabriz University of Medical Sciences
Expected recruitment start date
2011-12-31, 1390/10/10
Expected recruitment end date
2012-06-19, 1391/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Chlorella Vulgaris Supplementation on Oxidative Stress and Inflammatory Indices on Non-Alcoholic Fatty Liver Disease (NAFLD) Patients
Public title
The Effect of Chlorella Vulgaris Supplementation on Oxidative Stress and Inflammatory Indices on Non-Alcoholic Fatty Liver Disease (NAFLD) Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Liver steatosis on sonographic image; 20-50 years old; BMI>=30; moderately activity. Exclusion criteria: Alcohol intake more than 20g/d; gestation or lactation or Menopause; very active or inpatients; Cardiovascular disease; Pulmonary disease; renal disease; liver transplantation; other liver diseases and chronic or acute liver disease(Hepatitis A,B, ...); bilious impairments; cancers; inheritance diseases; using drugs like, insulin sensitivity enhancer, hepatotoxic drugs and estrogen.
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
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
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neyshabori Street
City
Tabriz
Postal code
Approval date
2012-04-16, 1391/01/28
Ethics committee reference number
5128
Health conditions studied
1
Description of health condition studied
non- alcoholic fatty liver disease
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Oxidative Stress Indicies
Timepoint
Beginning and end of the intervention
Method of measurement
TAC and ARE spectrophotometry, SOD and Gpx by Spectrometry and MDA thiobarbituric acid
2
Description
Inflammatory Indicies
Timepoint
Beginning and end of the intervention
Method of measurement
TNF-α and hs-CRP measurement with special kits
3
Description
Liver Enzyme (ALT,AST,ALP)
Timepoint
Beginning and end of the intervention
Method of measurement
IFCC
4
Description
Liver steatosis
Timepoint
Beginning and end of the intervention
Method of measurement
Liver Sonography
Secondary outcomes
1
Description
anthropometry
Timepoint
Begining and end of intervention
Method of measurement
Scale and meter
2
Description
Energy and nutrient intake
Timepoint
beginning, fourth week and end of the intervention