Protocol summary
-
Study aim
-
Determining the effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver
-
Design
-
Randomized clinical trial
-
Settings and conduct
-
The present study is a randomized controlled clinical trial to evaluate the effect of DASH counseling and diet on insulin resistance factors in patients with non-alcoholic fatty liver disease, which is referred to non-alcoholic fatty liver patients referred to the clinic Alikhani diabetes will be performed in Yazd for 12 weeks. In addition, people with diabetes receive their routine treatment under the supervision of a specialist. Smoking is a confounding factor and is eliminated in statistical models. Participation in the study is completely free and is managed by explaining in detail the study process, goals, benefits and limitations and obtaining written and oral consent with the patient's signature or, if necessary, by the patient's companion.
-
Participants/Inclusion and exclusion criteria
-
Inclusion criteria: 1. People 18 to 70 years old 2. People with body mass index 25 to 40 3. Diagnosis based on liver fiberoscan 4. Have informed consent. Exclusion criteria: 1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blocker and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Kushing syndrome 7.Kidney failure and kidney stones 8. Cardiovascular disease 9. People with a history of hepatitis B and C 10. Wilson disease
-
Intervention groups
-
DASH diet recipient group
-
Main outcome variables
-
Hepatic fibrosis, hepatic steatosis and liver enzymes
General information
-
Reason for update
-
We revised title and sample size. In addition, we added outcomes.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20170117032026N3
Registration date:
2022-02-06, 1400/11/17
Registration timing:
registered_while_recruiting
Last update:
2022-12-25, 1401/10/04
Update count:
1
-
Registration date
-
2022-02-06, 1400/11/17
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2022-01-21, 1400/11/01
-
Expected recruitment end date
-
2022-04-21, 1401/02/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
The effect of DASH diet on hepatic fibrosis, hepatic steatosis, liver enzymes, insulin resistance and oxidative stress in patients with non-alcoholic fatty liver disease
-
Public title
-
Effect of DASH diet in patients with non-alcoholic fatty liver disease
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Inclusion criteria: 1. People 18 to 70 years old 2. People with body mass index 25 to 40 3. Diagnosis based on liver fibroscan 4. Have informed consent.
Exclusion criteria:
1. Pregnancy and lactation 2. Hereditary hemochromatosis 3. History of gingival or gastroplasty bypass surgery 4. Use of hepatotoxic drugs such as calcium channel blockers and high doses of synthetic estrogens 5. Patients with hypothyroidism 6. Cushing's syndrome and 7. Kidney failure Kidney stones 8. Cardiovascular disease 9. People with a history of hepatitis B and C 10. Wilson disease
-
Age
-
From 18 years old to 70 years old
-
Gender
-
Both
-
Phase
-
3
-
Groups that have been masked
-
No information
-
Sample size
-
Target sample size:
70
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The distribution of people between groups is done randomly and a random allocation table created using a computer is used.
Randomization is block type and classification based on gender and body mass index. In this study, individuals will be divided into two groups of intervention and control.
-
Blinding (investigator's opinion)
-
Not blinded
-
Blinding description
-
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-10-30, 1400/08/08
-
Ethics committee reference number
-
IR.SSU.SPH.REC.1400.145
2
-
Ethics committee
-
-
Approval date
-
2021-10-30, 1400/08/08
-
Ethics committee reference number
-
IR.SSU.SPH.REC.1400.144
Health conditions studied
1
-
Description of health condition studied
-
Non-alcoholic fatty liver disease
-
ICD-10 code
-
DB92.Y
-
ICD-10 code description
-
Non-alcoholic fatty liver disease
Primary outcomes
1
-
Description
-
Alanine Aminotransferase
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kits
2
-
Description
-
Aspartat transaminase
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kits
3
-
Description
-
Gamma-glutamyl transpeptidase
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kits
4
-
Description
-
Hepatic fibrosis
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Fibroscan
5
-
Description
-
Hepatic steatosis
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Fibroscan
Secondary outcomes
1
-
Description
-
Weight, fat mass, fat free mass, RMR, body mass index and visceral fat
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Omron digital Scale
2
-
Description
-
Waist,Hip circumference
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Meter
3
-
Description
-
Diastolic blood pressure
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Sphygmomanometer
4
-
Description
-
Systolic blood pressure
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Sphygmomanometer
5
-
Description
-
Fasting blood sugar
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Special kit
6
-
Description
-
Insulin
-
Timepoint
-
Before intervention and 12 weeks after the intervention
-
Method of measurement
-
Special kit
7
-
Description
-
Total antioxidant capacity
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
8
-
Description
-
Catalase
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
9
-
Description
-
Superoxide dismutase
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
10
-
Description
-
PAB
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
11
-
Description
-
High sensitivity C-reactive protein
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
12
-
Description
-
Triglyceride
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
13
-
Description
-
Total cholesterol
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
14
-
Description
-
High density lipoprotein cholesterol
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
15
-
Description
-
Low density lipoprotein cholesterol
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Special kit
16
-
Description
-
Homeostatic model assessment of insulin resistance
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Formula
17
-
Description
-
Insulin sensitivity check index
-
Timepoint
-
Before intervention and 12 weeks after intervention
-
Method of measurement
-
Formula
Intervention groups
1
-
Description
-
DASH (Dietary Approaches to Stop Hypertension) diet. This diet contains 52 to 55% carbohydrates, 16 to 18% protein and 30% fat. The DASH diet is rich in fruits, vegetables, whole grains and low-fat dairy products, and is low in saturated fat, cholesterol and refined grains. Calories needed by each patient are estimated based on basal metabolic rate (using the Harris-Benedict equation) and levels of physical activity and energy from food metabolism. Everyone in the study is overweight or obese, and for these people the calorie limit of 500 to 700 kcal is less than the calculated energy requirement for each person. 500 kcal for those with a BMI in the range of 25-31 kg / m2 and 700 kcal for those with a BMI of more than 31 kg / m2 will be deducted from the total energy required by each person. An alternative list is provided to patients while educating the patient to facilitate food selection and to observe the principle of diversity between the components of each food group.
-
Category
-
N/A
2
-
Description
-
Standard diet
-
Category
-
N/A
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Yazd University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Undecided - It is not yet known if there will be a plan to make this available
-
Study Protocol
-
Undecided - It is not yet known if there will be a plan to make this available
-
Statistical Analysis Plan
-
Undecided - It is not yet known if there will be a plan to make this available
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Undecided - It is not yet known if there will be a plan to make this available
-
Analytic Code
-
Undecided - It is not yet known if there will be a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available