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.
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.
Design
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
Settings and conduct
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 8-weeks of interventions.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Intervention groups: patients who follow lacto ovo vegetarian diets
Control groups: patients who follow normal diets
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.
Public title
the effect of lacto ovo vegetarian and normal diets in nonalcoholic fatty liver disease
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 20 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Isfahan University of Medical Sciences
Street address
Department of Clinica Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.MUI.REC.1396.3.249
Health conditions studied
1
Description of health condition studied
Nonalcoholic Fatty Liver Disease.
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Liver enzymes (ALT, AST, ALP)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Using Microgram/ml - laboratory kit
2
Description
Lipid profile (TG, LDL, HDL, Total cholestrol)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
laboratory kit
3
Description
Liver steatosis index
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Sonography
Secondary outcomes
1
Description
Waist to hip ratio
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Non-stretchable tape without any pressure
2
Description
Body Mass Index (BMI)
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
Weight (kilograms) divided by the square of height (meters)
3
Description
Sistolic and diastolic blood pressure
Timepoint
The first day of the study and the last day of 8th week
Method of measurement
By mercury sphygmomanometer
Intervention groups
1
Description
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 8 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, …).
Category
Treatment - Other
2
Description
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 8 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.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
khorshid Hospital
Full name of responsible person
Mohammad hassan entezari
Street address
Khorshid Hospital, Ostandari Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Mohammad hassan entezari
Street address
Isfahan University of Medical Sciences,Hezar Jerib Avenue, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
entezari@hlth.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Vice Chancellor for Research, Isfahan 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
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Garousi
Position
MSc Student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
Garousinazila@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Mohammad hassan entezari
Position
Ph.D of nutrition, Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 1378
Email
Entezari@hlth.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Nazila Garousi
Position
MSc Student of Nutrition
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Department of Clinical Nutrition School of Nutrition and Food Sciences Isfahan University of Medical Sciences, Hezar Jarib Street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8487
Fax
+98 31 3668 8487
Email
Garousinazila@yahoo.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not 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