The effect of myo-inositol supplementation on nutritional status, cardiometabolic factors, liver function, oxidative stress and gene expression of HIF1α, NF-kB, TNF-α, Interleukin-1β and 6 in patients with non-alcoholic fatty liver disease.
Determining the effect of myo-inositol supplementation on nutritional status, cardio-metabolic factors, liver function, oxidative stress and expression of HIF1α, NF-κB, TNF-α, IL-1β and IL-6 genes in patients with non-alcoholic fatty liver
Design
Double-blinded placebo-controlled RCT on 50 patients
Settings and conduct
Individuals were randomly allocated into myo-inositol or placebo groups. The duration of the trial will be 8 weeks .At the beginning of the study, both groups will be given nutritional recommendations.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
patients with NAFLD (grade 1 and 2)
both sexes
age 18-55 years
BMI between 30-40 kg/m2
exclusion criteria:
Athlete, pregnancy, lactation and menopause
use of birth control pills and estrogen
Smoking and alcohol use
special diet
Use of chemical or herbal medicines for weight loss
Taking any supplement or medications affecting liver function for 3 months before or during the study
Diseases with similar pathogenesis
Intention of getting pregnant
Intervention groups
The intervention group will take myo-inositol supplement ( 2 gram sachets of myo-inositol before lunch and dinner) and placebo group (2 gram sachets of maltodextrin before lunch and dinner) for 8 weeks. At the beginning of the study, both groups will be given Nutritional recommendations.
Main outcome variables
Nutritional status (energy, macronutrients, micronutrients intake), Cardiometabolic status (glycemic indices (glucose-insulin-HbA1c-HOMA-IR score)- lipid profile (TG-TC-HDL-C-LDL-C)-SBP,DBP) Oxidative status (GPx ، SOD ، MDA ، CAT, NO, PON1 aryl esterase activity,TAC), Expression of inflammatory genes (HIF1α, NF-kB, TNF-α, IL-1β, IL-6), anthropometric indices (weight, BMI ,WC, WHR, WHtR)- body composition (Amount and % of body FM, FFM), liver function (liver ultrasonography and enzyme levels of ALT, AST and liver fibrosis score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100209003320N22
Registration date:2021-10-04, 1400/07/12
Registration timing:prospective
Last update:2021-10-04, 1400/07/12
Update count:1
Registration date
2021-10-04, 1400/07/12
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
2021-10-23, 1400/08/01
Expected recruitment end date
2022-04-21, 1401/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of myo-inositol supplementation on nutritional status, cardiometabolic factors, liver function, oxidative stress and gene expression of HIF1α, NF-kB, TNF-α, Interleukin-1β and 6 in patients with non-alcoholic fatty liver disease.
Public title
The effect of myo-inositol supplementation on NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18-55 years
Body mass index in the range of 30-40 Kg / m2
Willingness to cooperate
Hepatic steatosis based on Grade 1 and 2 NAFLD disease
Exclusion criteria:
Athlete, pregnancy, lactation and menopause in women
Infertility treatment, taking oral contraceptive pills
Smoking and alcohol use
Adherence to a special diet 3 months before the study
Use of chemical or herbal medicines for weight loss and use of hepatotoxic drugs such as phenytoin, amoxifine , lithium and antihypertensive drugs and lipid-lowering drugs (statins), insulin sensitiser medications
Taking antibiotics or dietary supplements that affect the levels of liver enzymes
History of weight loss surgery over the last year or rigid weight loss diets three months before the trial
Use of corticosteroids and NSAIDs or any type of supplements for 3 months before or during the study
Use of any multivitamin (vitamin E and folic acid, etc.), antioxidants (L-arginine, glutamine) and fish oil supplements for 3 months before or during the study
those with cardiovascular disease, hepatic, renal, intestinal, thyroid and parathyroid dysfunction, billiary disease, known autoimmune diseases, PCOs, cancers and conditions with mal-absorption such as Sprue and Crohn
Having symptoms of a recent infectious, inflammatory disease or recent surgery
Candidate or history of Liver transplant
Intention for pregnancy
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
A research assistant not otherwise involved in the study,
will be randomly allocated 50 patients into one of the two
experimental groups (1:1), using the Random allocation
software (RAS) and randomized block procedure of size
3 (age (18-30 vs 31-50 years)- gender (female vs male) and BMI
(<35 kg/m2 vs. ≥35 kg/m2)).
Blinding (investigator's opinion)
Double blinded
Blinding description
The person in charge of packaging myo-inositol and placebo supplements without knowing the content will determine the type of supplement or placebo that has no role in the implementation and analysis of the study data. None of the researchers or patients will be aware of the type of combination each person is receiving.
Placebo
Used
Assignment
Parallel
Other design features
Patients in both placebo and supplement groups will receive nutritional recommendations .
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Golgasht St., Attar Neishaboori Ave., Tabriz University of Medical Sciences, School of Nutrition & Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2021-09-13, 1400/06/22
Ethics committee reference number
IR.TBZMED.REC.1400.567
Health conditions studied
1
Description of health condition studied
non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Insulin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA method
2
Description
HbA1C
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Chromatography
3
Description
Total cholesterol
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic-colorimetric method using spectrophotometer
4
Description
Triglyceride
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic-colorimetric method using spectrophotometer
5
Description
HDL-C
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic-colorimetric method using spectrophotometer
a 3-days 24 hour- recall questionnaire at each phase will be completed and analyzed using Nutritionist 4 software
27
Description
Physical activity level
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Via short form of IPAQ questionnaire
28
Description
Appetite status
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Validated appetite questionnaire
29
Description
Weight
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
using Seca scale
30
Description
Serum albumin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
using BROMOCRESOL GREEN
31
Description
Platelets count
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using Coulter counter
Secondary outcomes
1
Description
Fatty liver grade
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Ultrasonigraphy
2
Description
NAFLD fibrosis score
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
According to the formula
3
Description
Alanine aminotransferase (ALT)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic method
4
Description
Aspartate aminotransferase (AST)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic method
Intervention groups
1
Description
Intervention group: Patients in this group will receive myo-inositol supplement and nutritional recommendation for 8 weeks. The supplement is: Sachet contains 2 grams of myo-inositol powder dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner.
Category
Treatment - Drugs
2
Description
Control group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. The placebo is: A sachet containing 2 grams of maltodextrin powder which will be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Nutrition and Food Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimi-Mameghani
Street address
Golgasht St. - Attar Neyshabouri St. - Tabriz University of Medical Sciences- School of Nutrition and Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Phone
+98 41 3335 7580
Email
ebrahimimamagani@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehrangiz Ebrahimi-Mameghani
Street address
Golgash St., Attar Neishaboori Ave., Tabriz University of Medical Sciences, School of Nutrition & Food Sciences
City
Tabriz
Province
East Azarbaijan
Postal code
51666-14711
Phone
+98 41 3335 7582
Email
ebrahimimamagani@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
Dr. Mehrangiz Ebrahimimamagani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street ,Attar neyshaburi street, nutriton faculty
City
Tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Email
mebrahimimameghani@gmail.com
Web page address
http://www.nutr.tbzmed.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golgasht street,Attar neyshabori street,Tabriz university of medical science,Nutrition faculty
City
tabriz
Province
East Azarbaijan
Postal code
5185747731
Phone
+98 41 3334 1113
Email
mebrahimimameghani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Sara Arefhosseini
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Faculty of Nutrition and Food Sciences., Attar Neyshaburi St, Golghast St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7582
Email
arefhosseini.sa@gmail.com
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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is 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
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