Protocol summary
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Study aim
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This study has intended to compare the therapeutic effects of two type of calorie restricted diets including Lacto-Ovo-Vegetarian and standard diet on the lipid profile, liver enzymes, and sonographic outcomes of the obese and overweight patients with nonalcoholic fatty liver disease.
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Design
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In this research, 80 nonalcoholic fatty liver disease referring to khorshid clinic were chosen purposefully and a code was allocated to each one of them.then, patient were randomly divided into two control and intervention groups
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Settings and conduct
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Data collection will be conducted in the specialist’s clinic of Khorshid hospital of Isfahan. Randomization will be conducted through a permuted block randomization of with size 2. Patients will be allocated between groups (1) and (2). Group (1) are the recipients of Lacto-ovo-vegetarian diet, and the group (2) consists of the recipients of a standard diet. At the beginning of the study, a blood sample and sonographic liver assessments will be derived from all patients. Based on the participants’ BMI, 200-500 Kcal will be reduced from the energy requirements and will be provided in a weekly dietary menu to both groups. Outcomes of the disease will be compared by a blood sample test and liver sonographic assessments, after 12-weeks of interventions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Over-weight or obese patients with the nonalcoholic fatty liver disease confirmed with imaging techniques.
exclusion criteria: Alcohol consumption; Pregnant and lactating women; Any known forms of hepatic or metabolic disease except Non alcoholic fatty liver disease;Using nutrition supplements;vegetarian diets; Hormone Therapy
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Intervention groups
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Intervention groups: patients who follow lacto ovo vegetarian diets
Control groups: patients who follow normal diets
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Main outcome variables
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liver enzymes, lipid profile, sonographic outcomes
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:
IRCT20140208016529N2
Registration date:
2018-05-31, 1397/03/10
Registration timing:
retrospective
Last update:
2020-08-01, 1399/05/11
Update count:
1
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Registration date
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2018-05-31, 1397/03/10
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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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Expected recruitment start date
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2017-12-30, 1396/10/09
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Expected recruitment end date
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2018-03-17, 1396/12/26
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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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Comparing the therapeutic effects of lacto-Ovo-vegetarian and standard diet on the lipid profile, liver enzymes, and sonographic results of obese and overweight patients with nonalcoholic fatty liver disease: A randomized controlled trial.
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Public title
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the effect of lacto ovo vegetarian and normal diets in nonalcoholic fatty liver disease
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Over-weight or obese patients with the nonalcoholic fatty liver disease confirmed with imaging techniques
increased levels of liver enzymes (serum levels of alanine aminotransferase and aspartate aminotransferase more than 40 U/L);
Body Mass Index (BMI) of them is greater than 24.9 and lower than 40
Exclusion criteria:
Alcohol consumption
Pregnant and lactating women
Any known forms of hepatic or metabolic disease except NAFLD, such as hereditary hemochromatosis, Wilson’s disease, cirosis,
other metabolic disease
history of gastric bypass or intestine surgery
Taking hepatotoxic drugs such as calcium channel blocker, methotrexate, amiodarone, chloroquine and anti inflammatory drugs;
Using nutrition supplements or vegetarian diets
Hormone Therapy
Patients with a history of hypothyroidism,
Cushing’s syndrome
renal failure
kidney stones.
Participants with less than 80% of adherence to the dietary plan are going to be excluded.
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Age
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From 20 years old to 55 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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No information
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Sample size
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Target sample size:
80
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study is a randomized controlled clinical trial. Randomization will be conducted through a permuted block randomization with size 2 and Participants will be allocated between groups 1 and 2. Group (1) are the recipients of a calorie restricted Lacto-ovo-vegetarian diet and the group (2) are the recipients of a calorie restricted standard diet.
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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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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2017-06-14, 1396/03/24
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Ethics committee reference number
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IR.MUI.REC.1396.3.249
Health conditions studied
1
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Description of health condition studied
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Nonalcoholic Fatty Liver Disease.
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ICD-10 code
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K75.81
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ICD-10 code description
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Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
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Description
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Liver enzymes (ALT, AST, ALP)
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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Using Microgram/ml - laboratory kit
2
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Description
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Lipid profile (TG, LDL, HDL, Total cholestrol)
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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laboratory kit
3
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Description
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Liver steatosis index
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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Sonography
Secondary outcomes
1
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Description
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Waist to hip ratio
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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Non-stretchable tape without any pressure
2
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Description
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Body Mass Index (BMI)
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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Weight (kilograms) divided by the square of height (meters)
3
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Description
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Sistolic and diastolic blood pressure
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Timepoint
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The first day of the study and the last day of 12th week
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Method of measurement
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By mercury sphygmomanometer
Intervention groups
1
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Description
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The energy requirements of intervention group are calculated with Mifflin-St Jeor equation on the basis of weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. Dietary plan of the intervention group has been designed based on lacto-ovo-vegetarian diet which refers to the meats elimination (red meats, poultry, fishes, shrimps, …).
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Category
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Treatment - Other
2
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Description
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The energy requirements of the control group are calculated with the Mifflin-St Jeor equation based on the weight, height, age, and sex of each participant. Take into account the patient’s condition, 200-500 Kcal energy is decreased from the total energy requirements. A 7 days’ dietary plan will be given to each participants including main meals and snakes for 12 consecutive weeks. The dietary plan of the control group considered to be a standard diet which all patients in the will be allowed to consume any foodstuff including all types of meats.
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Category
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Treatment - 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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No
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Title of funding source
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Vice Chancellor for Research, Isfahan 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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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not 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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No - There is not a plan to make this available