Alterations of liver enzymes and lipid profile in response to exhausting eccentric exercise after short-term vitamin D supplementation in the overweight female with non-alcoholic fatty liver
Evaluation of alterations of liver enzymes and lipid profile in response to exhausting eccentric exercise after short-term vitamin D supplementation in the overweight female with non-alcoholic fatty liver
Design
The present study is a randomized single-blind clinical trial with control group on patients with with non-alcoholic fatty liver.
Settings and conduct
30 samples were divided into experimental group (vitamin D recipient) and placebo (oral paraffin recipient) using a simple random sampling method . every groups received diet using adjusted ideal body weight. Macronutrient distribution in diet will be given in the form of 65-45% CHO, 10-15% and 30-35% fat. In this study, there are 2 visits for the patient at the beginning, and the end of the study. This study was conducted in the form of single-blind that patients and physicians be unaware of the type of intervention that they were taking.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People with non-alcoholic fatty liver/ 20 to 30 years/overweight; no use of any drug and / or surgical treatment; Not having any systemic disease and other endocrine disorders; Lack of Pregnancy and Breastfeeding
Exclusion criteria: Start taking or any dose changes in medications and participate in regular physical activity
Intervention groups
In this study, one group receiving vitamin D as intervention group and one group receiving oral paraffin as a control group.
Main outcome variables
Anthropometric indices, liver enzymes, lipid profile, insulin resistance and quality of life in patients with nonalcoholic fatty liver
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201130049538N1
Registration date:2021-07-05, 1400/04/14
Registration timing:retrospective
Last update:2021-07-05, 1400/04/14
Update count:0
Registration date
2021-07-05, 1400/04/14
Registrant information
Name
Zahra Rahim pour
Name of organization / entity
Razi University of Kermanshah
Country
Iran (Islamic Republic of)
Phone
+98 83 3431 1518
Email address
zahra.rahimpour.73@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-05-10, 1400/02/20
Expected recruitment end date
2021-06-10, 1400/03/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Alterations of liver enzymes and lipid profile in response to exhausting eccentric exercise after short-term vitamin D supplementation in the overweight female with non-alcoholic fatty liver
Public title
Short-term effect of vitamin D on liver enzymes and lipid profile in response to exhausting eccentric exercise
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight women with non-alcoholic fatty liver
Age 20 to 30 years
Body mass index above 25 to 29.99
Detection of non-alcoholic fatty liver by ultrasound
Vitamin D deficiency (25 levels of hydroxyvitamin D below 30 nanomoles / liter)
Exclusion criteria:
Muscle injury
Uncontrolled intake of vitamin D supplements
Doing regular exercise
smoking
Age
From 20 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, simple random sampling method will be used; And because the study population is small, the lottery method is used, That is, the names of the people are written on a piece of paper and placed inside the box, then the papers are taken out one by one until the desired sample size is complete.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, participants and health care personnel will be unaware of the type of intervention each patient receives. It should be noted that only the lead researcher will be aware of the intervention received for each patient.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kermanshah Razi University
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Approval date
2021-02-24, 1399/12/06
Ethics committee reference number
IR.RAZI.REC.1399.079
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
Lipid profile
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
2
Description
serum levels of liver enzymes
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
3
Description
glucose and insulin levels
Timepoint
Prior to the beginning and at the end of the study
Method of measurement
By blood sampling
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fourteen subjects, Vitamin D supplementation (including receiving vitamin D from Zahravi Pharmaceutical Company, at the rate of 2000 units per day for six weeks), Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.
Category
Lifestyle
2
Description
Control group: Fourteen subjects, Receive a placebo containing paraffin made by Zahravi Pharmaceutical Company of Iran (daily for six weeks) which is similar to vitamin D supplement in terms of shape, color, smell and taste. Exhaustive test and negative slope on the treadmill for two sessions (one session before supplementation and one session after supplementation), Control the intensity of exercise using a polar heart rate monitor and the Borg index, Blood sampling in four rounds. The first and second stages of sampling before and after the first training protocol and the third and fourth stages of sampling after the completion of the second training protocol.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam hosein hospital
Full name of responsible person
Zahra Rahimpour
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3431 1518
Email
zahra.rahimpour73@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
R.hoseini@Razi.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Razi University
Proportion provided by this source
10
Public or private sector
Private
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
Razi Univeristy
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
+98 83 3423 3267
Email
R.hoseini@razi.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
008334233267
Email
R.hoseini@razi.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Razi University
Full name of responsible person
Rastegar Hoseini
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Sport Nutrition
Street address
No.9, Taqh-Bostan Ave, University Blvd, Razi University.
City
Kermanshah
Province
Kermanshah
Postal code
6714967346
Phone
008334233267
Email
R.hoseini@razi.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data will be record in the SPSS software and will be available.
When the data will become available and for how long
Availability will start nine months after publishing all papers
To whom data/document is available
Only available for researchers in academic and scientific institutions
Under which criteria data/document could be used
All data can be used as reference
From where data/document is obtainable
zahra.rahimpour73@gmail.com
What processes are involved for a request to access data/document
If the explanation for data request would be convincing it will be given in 3 days.