1. Home
  2. Approved trials
  3. » فارسی

Effect of two isocaloric energy-restricted diets on non-alcoholic fatty liver disease patients: a cross over randomized controlled trial

Protocol summary

Summary
The aim of this study is to examine the effect of two isocaloric energy-restricted diets on non-alcoholic fatty liver disease patients. Maximum 40 Patients using NAFLD Registration research data file in Tabriz university who would like and have not diseases like renal and pulmonary diseases,…and not use hepatotoxic drugs and with moderate activity level will be selected. Patients will be randomly allocated into two diets with considering BMI and sex matching. Diet1 and Diet2 will be followed for 6 weeks. Daily energy requirement will be estimated based on age, sex, height, ideal body weight and physical activity level. Diets will be as follows: Diet 1: C 55%, F 25%, P 20% and Diet 2: C 40%, F 40% and P 20%. After the 6-week period, patients will start a 14-day washout period and then, in a cross-over manner, patients will be switched for the second 6-week period. Three days weighing food record questionnaires will be fulfilled. Obesity indices (inc. Body mass index, waist circumference , waist to hip ratio), fasting levels of ALT, AST, ALP, lipid profiles (inc. TC, HDL-C, LDL-C, TG, LP(a)), insulin resistance and liver echogenicity using sonography will be assessed at baseline, and end of each period.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811203320N1
Registration date: 2010-03-14, 1388/12/23
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-03-14, 1388/12/23
Registrant information
Name
Mehrangiz Ebrahimi mamagani
Name of organization / entity
Health & Nutrition faculty of Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 1113
Email address
ebrahimimamagani@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Liver and gastrointestinal diseaese research center, Nutritional research center, Tabriz university of medical sciences
Expected recruitment start date
2009-04-14, 1388/01/25
Expected recruitment end date
2009-09-22, 1388/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of two isocaloric energy-restricted diets on non-alcoholic fatty liver disease patients: a cross over randomized controlled trial
Public title
Effect of two different diets on non-alcoholic fatty liver disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Liver steatosis on sonographic image, 20-55 years old, BMI>=25, moderately activity. Exclusion criteria: Alcohol intake more than 20g/d, gestation or lactation, very active or inpatients, hypertension, Cardiovascular disease, Pulmonary disease, renal disease, liver transplantation, other liver diseases and chronic or acute liver disease(Hepatitis A,B, ...), bilious impairments, cancers, inheritance diseases, using drugs like blood pressure lowering, statins, insulin sensitivity enhancer, hepatotoxic drugs and estrogen
Age
From 20 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics commitee of Tabriz university of medical sciences
Street address
Tabriz university of medical sciences
City
Tabriz
Postal code
Approval date
2010-02-04, 1388/11/15
Ethics committee reference number
8812

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
Liver enzymes
Timepoint
begin and end of each phase
Method of measurement
Autoanalyser

Secondary outcomes

1

Description
Liver steatosis
Timepoint
begin and end of first phase(first 6 weeks) and end of second phase(second 6 weeks)
Method of measurement
Liver sonography

Intervention groups

1

Description
high carbohydrate diet (55%)
Category
Lifestyle

2

Description
high fat diet (40%)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Seikh alraees clinic
Full name of responsible person
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Liver and gastrointestinal diseaese research center
Full name of responsible person
Dr. Mohammad Hossein Somi
Street address
Imam Reza hospital
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Liver and gastrointestinal diseaese research center
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Nutritional research center
Full name of responsible person
Dr. Alireza Ostad Rahimi
Street address
Health & Nutrition Faculty
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nutritional research center
Proportion provided by this source
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

3

Sponsor
Name of organization / entity
Vice chancellor for research of Tabriz university of medical sciences
Full name of responsible person
Dr. Rasoul Azarfarin
Street address
Tabriz university of medical sciences
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Tabriz university of medical sciences
Proportion provided by this source
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
Health & Nutrition Faculty of Tabriz university of medical sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi
Position
Ph.D of Nutrition Epidemiology
Other areas of specialty/work
Street address
Health & Nutrition Faculty of Tabriz university of medical sciences
City
Tabriz
Postal code
Phone
+98 41 1335 7581
Fax
Email
ebrahimim@hotmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...