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The effect of myo-inositol supplementation on NAFLD

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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20210530051441N2
Enrollment
42
Registered
2022-03-12
Start date
2022-03-11
Completion date
Unknown
Last updated
2022-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-alcoholic fatty liver. Fatty (change of) liver, not elsewhere classified

Interventions

Intervention 1: 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 d

Sponsors

Qazvin University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 55 Years

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
Serum leptin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA method.;Serum adiponectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: ELISA method.;Ratio of leptin to adiponectin. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula.;Pro-oxidant Antioxidant Balance (PAB). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic and chemical methods.;Body mass index (BMI). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula.;Fat mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using bioelectric impedance analyzer.;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.;Physical activity level. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Via short form of IPAQ questionnaire.;Appetite status. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Validated appetite questionnaire.;Weight. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: using Seca scale.;Fat Free mass. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Using body analyzer based on bioelectric impedance.

Secondary

MeasureTime frame
Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy.;Alanine aminotransferase (ALT). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic method.;Aspartate aminotransferase (AST). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic method.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMohammad Reza Shiri Shahsavar

Qazvin University of Medical Sciences

nutshiri@gmail.com+98 28 3336 9581

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026