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The effect of a hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with non-alcoholic fatty liver disease

Protocol summary

Summary
Aim: This study’s aim is to compare the effect of a 12 weeks hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with Nafld. Methods: This study is a randomized controlled trial. One hundred and fourteen overweight and obese patients with Nafld will randomize (stratified block randomization method) to receive a hypocaloric diet consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction, or take 2 omega-3 fatty acids capsules per day providing 1500 mg EPA+DHA or be provided with no intervention for 12 week. Fasting blood samples (to measure alanine aminotransferase, aspartate aminotransferase, HDL-C, LDL-C, TG, TC, FBS, insulin), HOMA-IR, anthropometric measurements (weight, height, WC), physical activity and dietary intake data will be collected at baseline and at the end of the trial.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016082429508N1
Registration date: 2016-09-20, 1395/06/30
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-20, 1395/06/30
Registrant information
Name
Rasoul Zarrin
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 3346 9935
Email address
rasoul.zarrin@uqconnect.edu.au
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Urmia University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-20, 1395/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of a hypocaloric diet and omega-3 fatty acid supplementation on serum levels of liver enzymes, lipid profile and insulin resistance in overweight and obese patients with non-alcoholic fatty liver disease
Public title
The effect of hypocaloric diet and omega-3 fatty acid supplementation on overweight and obesity
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age between 18 and 65 years; the diagnosis of Nafld is established by the presence of steatosis of the liver on ultrasound associated with a persistent increase in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) of 1.5-4 times the upper limit of normal and AST:ALT<1; body mass index between 25 and 40 kg/m2; having informed consent. Exclusion criteria: pregnancy and lactation; alcohol consumption; substance abuse; engaging in strenuous exercise; any known pathological condition affecting the liver, e.g., autoimmune liver disease, hepatic virus infection, hepatobiliary disease,history of liver transplantation, hereditary defects (Wilson disease, hemochromatosis, ...), neoplasm, cardiovascular disease, endocrine disorders (diabetes mellitus, untreated hypothyroidism,...), bariatric surgery within the past year, engagement in an active weight loss program or taking weight-loss medication within the 3 months before the study, omega-3 fatty acid supplementation within the 3 months before the study; treatment with some medications (anticoagulant drugs, insulin-sensitizing drugs, statins, vitamin E), steatogenic and hepatotoxic medications and use of any medicine or dietary supplement that could influence glucose and lipid metabolism within the 3 months before the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 114
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

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Urmia University of Medical Sciences
Street address
UMSU Central Site,Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
Postal code
571478334
Approval date
2016-08-31, 1395/06/10
Ethics committee reference number
IR.UMSU.REC.1395.222

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
Fasting blood sugar
Timepoint
At baseline and after 3 month
Method of measurement
measured in milligram per deciliter, using colorimetry method

2

Description
Fasting insulin
Timepoint
At baseline and after 3 month
Method of measurement
measured in microUnit/milliliter, using Elisa

3

Description
HOMA-IR
Timepoint
At baseline and after 3 month
Method of measurement
using formula

4

Description
High density lipoprotein (HDL-C)
Timepoint
At baseline and after 3 month
Method of measurement
measured in milligram per deciliter, using colorimetry method

5

Description
Low density lipoprotein (LDL-C)
Timepoint
At baseline and after 3 month
Method of measurement
measured in milligram per deciliter, using colorimetry method

6

Description
Total cholesterol
Timepoint
At baseline and after 3 month
Method of measurement
measured in milligram per deciliter, using colorimetry method

7

Description
Triglyceride
Timepoint
At baseline and after 3 month
Method of measurement
measured in milligram per deciliter, using colorimetry method

8

Description
Alanine aminotransferase (ALT)
Timepoint
At baseline and after 3 month
Method of measurement
measured in international units/liter, using colorimetry method

9

Description
Aspartate aminotransferase (AST)
Timepoint
At baseline and after 3 month
Method of measurement
measured in international units/liter, using colorimetry method

10

Description
Weight
Timepoint
At baseline and after 3 month
Method of measurement
measured in kilograms, using digital scale

11

Description
Waist circumference
Timepoint
At baseline and after 3 month
Method of measurement
measured in centimeter, using a soft tape

12

Description
Body mass index
Timepoint
At baseline and after 3 month
Method of measurement
kg/m2, using standard formula

13

Description
Height
Timepoint
At baseline and after 3 month
Method of measurement
measured in meter, using mounted tape

Secondary outcomes

1

Description
Physical activity level
Timepoint
At baseline and after 3 month
Method of measurement
international physical activity questionnaire short form (IPAQ-SF)

Intervention groups

1

Description
First intervention group: Thirty eight patients with Nafld will receive a hypocaloric diet program consisting of 50% carbohydrates, 20% protein and 30% fat with a goal of 5% weight reduction. Dietary intake will assess by 24-hour recall method for 3 days and food frequency questionnaire at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the intervention.
Category
Treatment - Other

2

Description
Second intervention group: Thirty eight patients with Nafld will take 2 omega-3 fatty acids capsules per day providing 1500 mg EPA+DHA. Dietary intake will assess by 24-hour recall method for 3 days at baseline and the end of the trial. Anthropometric measurements, fasting blood sugar, fasting insulin, lipid profile (TC, LDL-C, HDL-C, TG), HOMA-IR, liver enzyme (ALT and AST) and physical activity data will be collected at baseline and the end of the interventio
Category
Treatment - Other

3

Description
Control group: no intervention
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Emam KHomeini Hospital
Full name of responsible person
Dr. Rasoul Zarrin
Street address
Department of nutrition, Faculty of Medicine, Pardis Nazlou, 11th km of Nazlou Road,Urmia,Iran
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Dr. Iraj Mohebbi
Street address
UMSU Central Site, Orjhans Street, Resalat Blvd, Urmia , Iran
City
Urmia
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, Urmia 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
Urmia University of Medical Sciences
Full name of responsible person
Dr. Rasoul Zarrin
Position
assistant professor of nutrition
Other areas of specialty/work
Street address
Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 3346 9935
Fax
+98 44 3345 7277
Email
Rasoul.zarrin@uqconnect.edu.au; wwzarrin@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Dr. rasoul Zarrin
Position
assistant professor of nutrition
Other areas of specialty/work
Street address
Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
+98 44 3346 9935
Fax
+98 44 3345 7277
Email
Rasoul.zarrin@uqconnect.edu.au; wwzarrin@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Urmia University of Medical Sciences
Full name of responsible person
Fatemeh Shojasaadat
Position
MSc student
Other areas of specialty/work
Street address
Department of nutrition, Medicine Faculty, Nazlou Pardis , 11th km of Nazlou Road,Urmia,Iran
City
Urmia
Postal code
Phone
Fax
Email
f_shojasaadat@yahoo.com; shojasaadat.f@umsu.ac.ir
Web page address

Sharing plan

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