Effects of the hypocaloric DASH diet (Dietary Approaches to Stop Hypertension) on liver enzymes, lipid profiles and insulin resistance in patients with fatty liver
Objective: The aim of this study is to determine the effects of the hypocaloric Dietary Approaches to Stop Hypertension (DASH) diet on insulin resistance, inflammatory factor and biomarkers of oxidative stress in patients with fatty liver. Study design: parallel single-blind randomized controlled clinical trial. Inclusion criteria: All patients with laboratorial and sonographical criteria of fatty liver. Exclusion criteria: Patients with viral hepatitis, hemochromatosis, Wilson or autoimmune hepatitis. Population and sample size: 60 patients with fatty liver among subjects of eligible and referred to Beheshti Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected. Intervention: Patients will be assigned to receive either the DASH diet (intervention group) or the standard diet (control group). Fasting blood samples will be taken at baseline and after 8-wk intervention to measure metabolic profiles, inflammatory factor and biomarkers of oxidative stress. Start and End Date of Intervention: 2 months (November 20, 2013-Jonvier 20, 2014). Outcomes: Baseline and End-of-trial fasting plasma glucose (FPG), serum insulin, hs-CRP levels, plasma total antioxidant capacity (TAC) and total glutathione (GSH) will be measured.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201311215623N14
Registration date:2013-12-11, 1392/09/20
Registration timing:registered_while_recruiting
Last update:
Update count:1
Registration date
2013-12-11, 1392/09/20
Registrant information
Name
Zatollah Asemi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 36 1534 3570
Email address
asemi_z@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2013-11-20, 1392/08/29
Expected recruitment end date
2014-01-19, 1392/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of the hypocaloric DASH diet (Dietary Approaches to Stop Hypertension) on liver enzymes, lipid profiles and insulin resistance in patients with fatty liver
Public title
Effect of low caloric diet in fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All patients with laboratorial and sonographical criteria of fatty liver. Exclusion criteria: Patients with viral hepatitis, hemochromatosis, Wilson or autoimmune hepatitis.
Age
From 30 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Approval date
2013-11-20, 1392/08/29
Ethics committee reference number
3462/1/5/29/P
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
Insulin
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
2
Description
Hs-CRP
Timepoint
Baseline and End-of-trial
Method of measurement
Elisa
3
Description
Total Antioxidant Capacity
Timepoint
Baseline and End-of-trial
Method of measurement
Spectrophotometry
4
Description
Fasting plasma glucose
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
5
Description
ALT
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
6
Description
AST
Timepoint
Baseline and End-of-trial
Method of measurement
Enzymatic
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 8 weeks
Category
Other
2
Description
Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 8 weeks
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Beheshti Clinic
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Zatollah Asemi
Position
Nutrition PhD
Other areas of specialty/work
Street address
Bolvare Ghotbe Ravandi, Kashan
City
Kashan
Postal code
Phone
+98 36 1446 3378
Fax
Email
asemi_z@kaums.ac.irasemi_r@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Full name of responsible person
Zatollah Asemi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)