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The effect of myoinositol supplementation on serum levels of Pro-oxidant Antioxidant Balance (PAB), leptin and adiponectin, nutritional status and appetite in patients with non-alcoholic fatty liver disease

Protocol summary

Study aim
to determine the effect of myoinositol supplementation on serum levels of Pro-oxidant Antioxidant Balance (PAB), leptin and adiponectin , nutritional status and appetite in patients with non-alcoholic fatty liver disease
Design
Double-blinded placebo-controlled randomized controlled trial
Settings and conduct
The volunteers being eligible to participate in the study will be randomly allocated into "Myo-inositol" or "Placebo" group and followed the intervention for 8 weeks. At the beginning and and after 8 weeks, 7 cc 12-14 hour fasting blood was taken and serum samples would be used to assess liver enzymes, leptin, adiponectin and PAB.
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 contraceptive pills and estrogen Smoking and alcohol drinking Use of any supplement or mediccations affecting liver function over last 3 months Diseases with similar pathogenesis tend to be pregnant
Intervention groups
The intervention group will take myo-inositol supplement (2 gr sachets of myo-inositol before lunch and dinner) and placebo group (2 gr 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), Leptin and adiponectin status and their ratio, Pro-oxidant Antioxidant Balance (PAB) status, anthropometric indices (weight, BMI)- body composition (Amount and % of body FM, FFM), liver function (liver ultrasonography and enzyme levels of ALT, AST)

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210530051441N2
Registration date: 2022-03-12, 1400/12/21
Registration timing: registered_while_recruiting

Last update: 2022-03-12, 1400/12/21
Update count: 0
Registration date
2022-03-12, 1400/12/21
Registrant information
Name
Mohammad Reza Shiri Shahsavar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3336 9581
Email address
nutshiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-08-21, 1401/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of myoinositol supplementation on serum levels of Pro-oxidant Antioxidant Balance (PAB), leptin and adiponectin, nutritional status and appetite 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 = 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 Smoking and drinking alcohol Adherence to a special diet or weight loss 3 months before the study Use of chemical or herbal medicines for weight loss, hepatotoxic (phenytoin, amoxifine, lithium), lipid-lowering (statins), Insulin sensitizer, corticosteroids and non-steroidal, anti-inflammatory medications and any dietary supplements for 3 months before the study History of weight loss surgery over the last year those with cardiovascular, hepatic, renal, intestinal, thyroid and parathyroid dysfunction, billiary, any known autoimmune diseases, PCOs, cancers and conditions with mal-absorption such as Sprue and Crohn Candidate or history of Liver transplant
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: 42
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random allocation will be performed using the r.allocation command in Stata/MP 17.0*64 software, which performs both stratification and blocking at the same time. Thus, 42 eligible patients will be classified into 8 stratas based on 3 variables: age, sex and BMI (age ("18-35" vs "36-50"), gender ("female" vs "male"), BMI ("30-35 Kg/m2" vs "35-40 Kg/m2")) and we will define these 8 stratas in the r.allocation command. Also, since we will have 2 intervention and placebo groups, we will define blocks with size 2, which will be generated automatically by the Stata software at the same time, and we will use the generated sequence for random allocation.
Blinding (investigator's opinion)
Double blinded
Blinding description
The person who packaged supplements/placebo will not be aware about the content and also has no role in the implementation and analysis of the 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
Qazvin university of medical science
Street address
Qazvin university of medical sciences, bahanor blv.
City
Qazvin
Province
Qazvin
Postal code
3419759811
Approval date
2021-11-30, 1400/09/09
Ethics committee reference number
IR.QUMS.REC.1400.340

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
serum leptin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA method

2

Description
serum adiponectin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
ELISA method

3

Description
Ratio of leptin to adiponectin
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
According to the formula

4

Description
Pro-oxidant Antioxidant Balance (PAB)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Enzymatic and chemical methods

5

Description
Body mass index (BMI)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
According to the formula

6

Description
Fat mass
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using bioelectric impedance analyzer

7

Description
Energy, macronutrients and micronutrients intakes
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
a 3-days 24 hour- recall questionnaire at each phase will be completed and analyzed using Nutritionist 4 software

8

Description
Physical activity level
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Via short form of IPAQ questionnaire

9

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

10

Description
Weight
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
using Seca scale

11

Description
Fat Free mass
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Using body analyzer based on bioelectric impedance

Secondary outcomes

1

Description
Fatty liver grade
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
Ultrasonigraphy

2

Description
Alanine aminotransferase (ALT)
Timepoint
Baseline and 8 weeks after intervention
Method of measurement
enzymatic method

3

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. Two 2 gr sachet of myo-inositol powder will be asked to be dissolved in a glass of water and consumed twice a day 30 minutes before lunch and dinner. As there is no specific recommendation for NAFLD we use the American Diabetes Association that recommends consuming more fruits, vegetables, whole grains and less saturated fatty acids.
Category
Treatment - Drugs

2

Description
Placebo group: Patients in this group will receive placebo and nutritional recommendations for 8 weeks. Two 2 gr sachet of maltodextrin powder which will be asked to 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
Velayat hospital- Qazvin
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Street address
Qazvin University of Medical Sciences, Bahonar blv,
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Street address
Qazvin University of Medical Sciences, bahonar blv
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com
Grant name
vice chancellor for research and technology of qazvin university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
قزوین بلوار باهنر دانشگاه علوم پزشکی
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Shiri Shahsavar
Position
assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Qazvin university of medical sciences, Bahonar blv
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
nutshiri@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Zahra Alizadeh Zonouzi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Qazvin university of medical sciences, Bahonar blv
City
Qazvin
Province
Qazvin
Postal code
3419759811
Phone
+98 28 3336 9581
Email
z.alizadeh76@yahoo.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
From where data/document is obtainable
Mrs.Zahra alizadeh zonouzi, Email address: z.alizadeh76@yahoo.com, cellphone number: 09388202522
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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