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A comparative study of the effect of low calorie balanced diet versus low calorie high fiber diet on the hepatic transaminases, lipid profiles, insulin, glucose levels, blood pressure and anthropometric measurements of obese patients with nonalcoholic fatty liver disease(NAFLD)

Protocol summary

Summary
The aim of our study was to examine the changes in hypertransaminasemia after weight reduction in obese patients with nonalcoholic fatty liver disease (NAFLD) and the relation with insulin resistance. A convenient, clinical trials study with 3 months treatment period. 80 patients (men and women) aged 20-60 years old were selected among the patient referred to gastroenterology clinic of Motahary Center. Patients selection was based on BMI ≥ 25 kg/m2, ALT≥ 43 UI/L and NAFLD patient. A population of 80 obese patients with NAFLD was randomly allocated to two groups: a) diet I (low calorie high fiber diet, high-fibre (>15 g/1,000 kcal)) and b) diet II (low calorie balanced diet), dieting along 3 months. The two diets containing 18% protein, 28% fat and 55% carbohydrate. A fasting blood sample for measuring liver function tests were collected at the beginning and after 3 months consumption of two diets. At baseline and after 3 months, the index of ALT, AST.GGT.BT, total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, blood glucose, insulin and blood pressure will be measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201111218145N1
Registration date: 2012-02-16, 1390/11/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-02-16, 1390/11/27
Registrant information
Name
Mousa Salehi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1726 9147
Email address
salehi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, shiraz University of Medical Sciences
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-06-19, 1391/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the effect of low calorie balanced diet versus low calorie high fiber diet on the hepatic transaminases, lipid profiles, insulin, glucose levels, blood pressure and anthropometric measurements of obese patients with nonalcoholic fatty liver disease(NAFLD)
Public title
Comparison of weight loss diets on long-term consequences of fatty liver disease in patients referred to the clinic Motahari Shiraz, 1390
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-60; BMI>25; ALT>43 Exclusion criteria: Alcohol consumption; Hepatitis B; C; Cytomegalovirus; Epstein Barr infections; nonorgan-specific autoantibody hereditary defects (iron storage disease and copper; alpha-1 anti-trypsin deficiency)
Age
From 20 years old to 60 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Zand Avenue, Central Medical Building, Shiraz
City
Shiraz
Postal code
PO Box 1978-71345
Approval date
2011-11-12, 1390/08/21
Ethics committee reference number
CT-905784

Health conditions studied

1

Description of health condition studied
Nonalcoholic fatty liver disease
ICD-10 code
K76
ICD-10 code description
Nonalcoholic steatohepatitis

Primary outcomes

1

Description
ALT
Timepoint
Before and 3 months after intervention
Method of measurement
Colorimetric method

2

Description
AST
Timepoint
Before and 3 months after intervention
Method of measurement
Colorimetric method

3

Description
GGT
Timepoint
Before and 3 months after intervention
Method of measurement
Colorimetric method

4

Description
Bilirubin total
Timepoint
Before and 3 months after intervention
Method of measurement
Colorimetric method

Secondary outcomes

1

Description
Insulin
Timepoint
Before and 3 months after intervention
Method of measurement
ELISA kit

2

Description
lipid profile
Timepoint
Before and 2 months after intervention
Method of measurement
Auto analyzer

3

Description
FBS
Timepoint
Before and 2 months after intervention
Method of measurement
Auto analyzer

4

Description
Body fat mass
Timepoint
Before and 3 months after intervention
Method of measurement
Body Composition Analyzer - Quad Scan 4000

5

Description
Blood pressure
Timepoint
Before and 3 months after intervention
Method of measurement
Mercury Barometer

6

Description
Weight
Timepoint
Before and 3 months after intervention
Method of measurement
Seca Scale

7

Description
Height, waist hip circumference
Timepoint
Before and 3 months after intervention
Method of measurement
Tape Meter

Intervention groups

1

Description
Receive a balanced low-calorie high-fiber diet for 3 months (reduction of 700 kcal daily intake and received more than 15 grams of fiber per 1,000 kcal according to the definition of high-fiber diet(
Category
Lifestyle

2

Description
Receive a balanced low-calorie diet for 3 months (reduction of 700 kcal daily intake and get as much as 14 grams of fiber per 1000 kcal intake according to the definition of balanced diet)
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Shiraz Motahari Clinic
Full name of responsible person
Dr Seyed Kazem Hosseini Asl
Street address
Zand Avenue, Namazi Square, Motahari Clinic
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahmedini
Street address
Zand Avenue, Central Medical Building
City
Shiraz
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, Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Name of organization / entity
School of Health And Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Bayan Roohi
Position
MSc. student of nutrition
Other areas of specialty/work
Street address
Razi Street, Department of Nutrition, School of Health and Nutrition
City
Shiraz
Postal code
PO Box 715367-5541
Phone
+98 71 1725 1001
Fax
Email
bayan.roohi@yahoo.com rouhib@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Health and Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Dr Mosa Salehi
Position
Associate Professor
Other areas of specialty/work
Street address
Razi Street, Department of Nutrition, School of Health and Nutrition
City
Shiraz
Postal code
PO Box 715367-5541
Phone
+98 71 1725 1001
Fax
Email
salehi@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
School of Health and Nutrition, Shiraz University of Medical Sciences
Full name of responsible person
Bayan Roohi
Position
MSc. nutrition student
Other areas of specialty/work
Street address
Razi Street, Department of Nutrition, School of Health and Nutrition
City
Shiraz
Postal code
PO Box 715367-5541
Phone
+98 71 1726 0225
Fax
Email
bayan.roohi@yahoo.com rouhib@sums.ac.ir
Web page address

Sharing plan

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