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The effect of DASH-based weight loss diet on serum Lipopolysaccharide level and meta-inflammation status among patients with non-alcoholic fatty liver disease

Protocol summary

Study aim
The aim of the present study is to investigate the effect of DASH-based weight loss diet on serum Lipopolysaccharide level and meta-inflammation status among patients with non-alcoholic fatty liver disease.
Design
Randomized double blind clinical trial with two arm parallel groups
Settings and conduct
Volunteer patients in the Tabriz city whose disease is diagnosed by a newly diagnosed specialist will be included in the study and met the inclusion criteria and will be randomly assigned to the intervention and control groups.
Participants/Inclusion and exclusion criteria
44 patients with grade 1 and 2 NAFLD aged 20-50 years and BMI 30-40 kg / m2 will be included in the study.Alcohol consumption, pregnancy, breastfeeding , menopause , being an athlete , having a weight loss diet 3 months before the study , the use of lowering blood sugar , lipid , blood pressure drugs , antibiotics and corticosteroids , suffering from metabolic disease , cardiovascular , renal , kidney stone , liver disease , thyroid disease , autoimmune and cancer are among the exclusion criteria.
Intervention groups
Patients in the intervention group will receive a weight loss diet based on the DASH diet. Patients in the control group will receive the usual weight loss diet.
Main outcome variables
Nutritional status (anthropometric indices , and calorie and macronutrients intake),Serum levels of liver enzymes (ALT, AST) and ultrasound findings ,Serum levels of lipopolysaccharides(LPS) , Meta-inflammation status ( MCP-1, TLR-4 )

General information

Reason for update
Acronym
NAFLD
IRCT registration information
IRCT registration number: IRCT20100209003320N17
Registration date: 2019-12-22, 1398/10/01
Registration timing: retrospective

Last update: 2019-12-22, 1398/10/01
Update count: 0
Registration date
2019-12-22, 1398/10/01
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
2019-10-23, 1398/08/01
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of DASH-based weight loss diet on serum Lipopolysaccharide level and meta-inflammation status among patients with non-alcoholic fatty liver disease
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 Breastfeeding Menopause Being an athlete Having a weight loss diet 3 months before the study The use of lowering blood sugar , lipid , blood pressure drugs , antibiotics and corticosteroids Suffering from metabolic disease , cardiovascular , renal , kidney stone , liver disease , thyroid disease , autoimmune and cancer
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 placebo groups using a software generated random permuted blocks. The generated random sequence will be kept in a protected location and administered by an independent third party who is blind to the trial throughout the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the main investigators (including the student and her supervisors and adviser professors), as well as the patients will be blinded to the type of diet (DASH diet or the usual weight loss diet) received by each 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
5166/1573113
Approval date
2019-10-21, 1398/07/29
Ethics committee reference number
IR.TBZMED.REC.1398.741

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
Calorie and macronutrients intake
Timepoint
Baseline and 4 weeks after the intervention and 8 weeks after the intervention
Method of measurement
The intake of calorie and macronutrients from the diet of the subjects with using a 3 day food record questionnaire and analysis by the nutritionist 4 program.

2

Description
Anthropometric Indices
Timepoint
Baseline and 8 weeks after the intervention
Method of measurement
Measurement of height and weight without shoes and with minimum clothes on, by Seca stadiometer and scale, respectively. Measurement of waist and hip circumference by a tape measure and body mass index (BMI) by dividing weight (kg) by height squared (m2)

3

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

4

Description
Serum levels of lipopolysaccharide
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA

5

Description
Inflammatory indices ( MCP-1 , TLR-4 )
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA

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
Sheikholrais Clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Azadi street
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3335 7314
Email
ebrahimimamagani@tbzmed.ac.ir

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?
No
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
Farnaz Rouhollahzadegan
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
farnazrz69@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
Farnaz Rouhollahzadegan
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
farnazrz69@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
Ms.Farnaz Rouhollahzadegan, E-mail address:farnazrz69@gmail.com, cellphone number: 0098 9014574722
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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