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The effect of weight loss diet based on DASH diet on proxidant-antioxidant balance levels, lipid profile, liver fibrosis score, appetite status and quality of life in patients with non-alcoholic fatty liver

Protocol summary

Study aim
The aim of the present study is to investigate the effect of weight loss diet based on DASH diet on Pro-Oxidant-Antioxidant Balance (PAB) , lipid profile, liver fibrosis score, appetite status and quality of life among patients with non-alcoholic fatty liver disease.
Design
Double blind randomized controlled clinical trial
Settings and conduct
The patients who newly diagnosed as NAFLD and met the inclusion criteria will be included in the study and then randomly assigned into the intervention and control groups.
Participants/Inclusion and exclusion criteria
44 patients with grade 1 and 2 NAFLD who aged 20-50 years with BMI 30-40 kg / m2 will be included in the study. Those with alcohol consumption, pregnancy, lactation, menopause, being an athlete, having a weight loss diet 3 months before the study, the use of lowering blood sugar, lipid drugs, antibiotics , corticosteroids and antioxidant supplements , suffering from metabolic disease inc. cardiovascular, renal, liver, thyroid, autoimmune diseases, kidney stones and cancers will be excluded.
Intervention groups
The intervention group will receive a weight loss diet based on the DASH diet while the control group will receive the usual weight loss diet.
Main outcome variables
Nutritional status (anthropometric indices , and energy and macronutrients intakes), ultrasonography findings, serum levels of Pro-Oxidant-Antioxidant Balance (PAB), lipid profile, liver fibrosis score, appetite status and quality of life

General information

Reason for update
Acronym
NAFLD
IRCT registration information
IRCT registration number: IRCT20100209003320N19
Registration date: 2021-06-06, 1400/03/16
Registration timing: prospective

Last update: 2021-06-06, 1400/03/16
Update count: 0
Registration date
2021-06-06, 1400/03/16
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
Expected recruitment start date
2021-06-07, 1400/03/17
Expected recruitment end date
2021-10-10, 1400/07/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of weight loss diet based on DASH diet on proxidant-antioxidant balance levels, lipid profile, liver fibrosis score, appetite status and quality of life in patients with non-alcoholic fatty liver
Public title
The effect of DASH diet on NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ages 20-50 Grade 1 and 2 NAFLD disease Body mass index in the range of 30-40 Kg / m2 Willingness to cooperate
Exclusion criteria:
Alcohol consumption Pregnancy Lactation Menopause Being an athlete Having a weight loss diet 3 months before the study The use of lowering blood sugar, lipid drugs , antibiotics , corticosteroids and Antioxidant supplement Suffering from metabolic diseases inc. cardiovascular, renal, liver, thyroid, autoimmune diseases, kidney stone and cancers
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
44 eligible patients will be randomly allocated to intervention and control groups using random blocks by an independent third party who is blinded to the trial.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators (patients and investigators),will be blinded to the type of diet (DASH diet or the usual weight loss diet) received by each patient and group
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Attar Neishabouri Ave., Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Approval date
2021-04-12, 1400/01/23
Ethics committee reference number
IR.TBZMED.REC.1400.009

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
Energy and macronutrients intakes
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
The intake of energy and macronutrients of the subjects using a 3-day food record questionnaire analyzed by the nutritionist 4 software.

2

Description
Anthropometric Indices
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Measing height and weight without shoes and with minimum clothes using Seca stadiometer. Waist and hip circumferences will be measured using a tape and then body mass index (BMI) will be estimated by dividing weight (kg) to height squared (m2)

3

Description
Liver enzymes (ALT , AST )
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

4

Description
albumin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

5

Description
platelet count
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
cell counter

6

Description
Pro-Oxidant Antioxidant Balance (PAB)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA

7

Description
lipid profile
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic colorimetric method

8

Description
liver fibrosis score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Liver fibrosis score formula

9

Description
Blood glucose
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method

10

Description
Appetite status
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Validated appetite questionnaire

11

Description
quality of life
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Quality of Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Patients in this group will receive the DASH-based weight loss diet for 8 weeks.
Category
Lifestyle

2

Description
Control group: Patients in this group will receive the usual weight loss diet for 8 weeks.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sheikhoreis Clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
ebrahimimamagani@tbzmed.ac.ir
Web page address

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Alireza Ostad Rahimi
Street address
Faculty of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 2292
Email
nut-rc@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Taghi Badali
Position
MSC student of nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences.,Attar Neyshaburi St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
Tbadali17@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr.Mehrangiz Ebrahimi Mamagani
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St., Golghasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
ebrahimimamagani@tbzmed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taghi Badali
Position
MSC student of nutrition sciences
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences.,Attar Neyshaburi St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
Tbadali17@gmail.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
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data collected for the primary outcomes will be shared.
When the data will become available and for how long
Access starting 12 months after publication
To whom data/document is available
The data will only be available for people working in academic institutions .
Under which criteria data/document could be used
The data of the present study will only be accessible by other researchers , for conducting meta-analysis .
From where data/document is obtainable
Taghi Badali, E-mail address:Tbadali17@gmail.com, cellphone number: 0098 9144565411
What processes are involved for a request to access data/document
The applicant should provide a brief description of the aims and methods of his Meta-analysis . His request will be assessed and , if agreed, the data will be emailed to the applicant. All these procedures will take no longer than 15 days.
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