Protocol summary
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Study aim
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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.
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Design
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Study design: parallel single-blind randomized controlled clinical trial.
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Settings and conduct
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Population and sample size: 60 patients with fatty liver among subjects of eligible and referred to Naghavi Clinic affiliated to Kashan University of Medical Sciences, Kashan, Iran in the study will be selected.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Patients with laboratorial and sonographical criteria of fatty liver and aged 25 to 75 years will be included in this study. Exclusion criteria: Consumption of alcohol, pregnancy and lactation, hereditary hemochromatosis, history of jejunoileal bypass surgery or gastroplasty, taking hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens, history of hypothyroidism, cushing’s syndrome, renal failure and kidney stones.
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Intervention groups
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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
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Main outcome variables
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Outcomes: Alanine aminotransferase (primary outcome), and clinical and metabolic profiles (secondry outcomes) will be quantified at the study baseline and end-of-trial.
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201311215623N14
Registration date:
2013-12-11, 1392/09/20
Registration timing:
prospective
Last update:
2019-09-28, 1398/07/06
Update count:
1
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Registration date
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2013-12-11, 1392/09/20
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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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Kashan University of Medical Sciences
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Expected recruitment start date
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2014-11-01, 1393/08/10
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Expected recruitment end date
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2015-01-30, 1393/11/10
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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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Effects of the hypocaloric DASH diet (Dietary Approaches to Stop Hypertension) on liver enzymes, lipid profiles and insulin resistance in patients with fatty liver
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Public title
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Effect of low caloric diet in fatty liver
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Subjects aged 25-75 years
All patients with laboratorial and sonographical criteria of fatty liver.
Exclusion criteria:
Consumption of alcohol
Pregnancy and lactation
Hereditary hemochromatosis
History of jejunoileal bypass surgery or gastroplasty
Taking hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens
History of hypothyroidism
Cushing’s syndrome
Renal failure and kidney stones
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Age
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From 25 years old to 75 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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At study baseline and after stratification for pre-intervention BMI and age, subjects will be randomly divided into two groups to take DASH (n = 30) or control (n = 30). Randomization will be done by the use of computer-generated random numbers.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants and the assessors of the outcomes are unaware of the study groups.
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Placebo
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Not 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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2013-11-20, 1392/08/29
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Ethics committee reference number
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3462/1/5/29/P
Health conditions studied
1
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Description of health condition studied
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Non Alcoholic Fatty Liver Disease
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ICD-10 code
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k76.0
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ICD-10 code description
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Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
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Description
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ALT
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
Secondary outcomes
1
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Description
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AST
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
2
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Description
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Insulin
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
3
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Description
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Hs-CRP
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa
4
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Description
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Total Antioxidant Capacity
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
5
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Description
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Fasting plasma glucose
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic
6
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Description
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Triglycerides
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
7
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Description
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HDL-cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
8
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Description
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Total cholesterol
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Enzymatic kit
9
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Description
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Nitric oxide
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
10
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Description
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Malondialdehyde
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
11
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Description
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Glutathione
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Spectrophotometry
12
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Description
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Insulin resistance
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Elisa kit
13
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Description
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Grade of fatty liver
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Timepoint
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Baseline and End-of-trial
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Method of measurement
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Sonography
Intervention groups
1
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Description
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Intervention group: DASH diet, 6 serving vegetables, 6 serving fruits, rich in fiber and whole grains, daily for 8 weeks
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Category
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Other
2
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Description
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Control group: Standard diet, 4 serving vegetables, 4 serving fruits, rich in protein, daily for 8 weeks
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Category
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Other
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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Kashan 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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Undecided - It is not yet known if there will be a plan to make this available
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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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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available