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The effect of myo-inositol supplementation on NAFLD

The effect of myo-inositol supplementation and placebo on the expression level of SIRT-1 pathway genes (SIRT-1, eNOS, NF-kB, LDLR, LOX-1, LXRa, ABCA1 and PCSK9) involved in atherosclerosis in peripheral blood mononuclear cells of patients with non-alcoholic fatty liver disease

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190724044322N2
Enrollment
44
Registered
2022-04-18
Start date
2022-05-10
Completion date
Unknown
Last updated
2022-05-02

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 oral myo-inositol (a water soluble six carbon alcoholic sugar) supplement and nutritional recommendation (at the beginning and d

Sponsors

Tabriz 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 in the range of 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 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 insulin sensitizer medications, antibiotics or any kind of supplements that may affect liver enzymes History of weight loss surgery over the last year or rigid weight loss diets three months before the trial Use of NSAIDs or any any multivitamin or 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 use of any antihypertensive drugs and lipid-lowering drugs (statins) and medications related to cardiovascular patients Candidate or history of Liver transplant Intention for pregnancy

Design outcomes

Primary

MeasureTime frame
Sirtuin-1 (SIRT-1) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Nuclear factor kappa-B (NF-kB) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Endothelial nitric oxide synthase (eNOS) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Low density lipoprotein receptor (LDLR) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Lectin-type oxidized LDL receptor 1 (LOX-1) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Liver X receptor alpha (LXR-alpha) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;ATP Binding Cassette Subfamily A Member 1(ABCA1) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).;Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) gene expression. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Real-time polymerase chain reaction (RT-PCR).

Secondary

MeasureTime frame
Weight. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: using Seca scale.;Body mass index (BMI). Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula.;Fatty liver grade. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Ultrasonigraphy.;Total cholesterol. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic-colorimetric method using spectrophotometer.;Triglyceride. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: enzymatic-colorimetric method using spectrophotometer.;HDL-C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: Enzymatic-colorimetric method using spectrophotometer.;LDL-C. Timepoint: Baseline and 8 weeks after intervention. Method of measurement: According to the formula.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactNeda Roshanravan

Tabriz University of Medical Sciences

neda.roshanravan10@gmail.com+98 41 3337 3958

Outcome results

None listed

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