The effect of oral alpha-lipoic acid supplement on nonalcoholic fatty liver disease patients

The effect of oral alpha-lipoic acid supplement on nutritional status and serum levels of metabolic, oxidative, inflammatory indicators and serum cytokeratin-18 in nonalcoholic fatty liver disease patients

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

IRCT

Registry ID

IRCT201511143320N12

Enrollment

Registered

2015-12-24

Start date

2015-12-22

Completion date

Unknown

Last updated

2018-02-22

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

Conditions

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

Interventions

Intervention 1: Intervention group: Daily Oral consumption of 2 capsule contain 600 mg alpha-lipoic acid supplement. Intervention 2: Control group: Daily Oral consumption of 2 capsule contain 600 mg p

Treatment - Other

Intervention group: Daily Oral consumption of 2 capsule contain 600 mg alpha-lipoic acid supplement

Control group: Daily Oral consumption of 2 capsule contain 600 mg placebo

Eligibility

Sex/Gender

All

Age

20 Years to 50 Years

Inclusion criteria

Inclusion criteria: Inclusion criteria: Desire to participate in the study, confirmation of NAFLD with liver Ultrasonography, aged 20-50 years from both gender, body mass index between 30-40 kg/m2, taking 400IU/day vitamin E, moderate physical activity level Exclusion criteria: Alcohol consumption, smoking, pregnant, lactating and menopausal women, very active subjectes or athletes, hospitalized subjects, suffering from hypertension, cardiovascular diseases, pulmonary diseases, renal diseases, liver transplantation, other acute and chronic liver diseases, biliary system disorders, cancer, Inherited disorders affecting the liver. Receiving Oral Contraceptive Pill (OCP) and antioxidant vitamins unless vitamin E, hypertension and thyroid affecting drugs, statins, inflammation and Insulin sensitivity affecting drugs and Hepatotoxic drugs including phenytoin, amiodarone, levothyroxine, tamoxifen and lithium

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Hepatic steatosis. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Ultrasound of liver.;Liver enzymes (ALP, ALT, AST). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum concentration of these enzymes with enzymatic method by kits.;Fasting Blood Sugar (F.B.S.). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method.;Serum insulin level. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chemoluminescense.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Calculation of HOMA-IR.;Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Triglyceride, total cholesterol and HDL-cholesterol with spectrophotometry and LDL-cholesterol with Friedewald equation.;Oxidative indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Total antioxidant capacity (TAC) by using spectrophotometry, MDA by using thiobarbituric acid, SOD and GPX activities by using ELIZA kits.;Inflammatory indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum levels of TNF-a? TGF-ß and IL-10 by using ELIZA kits.;Sirtuin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Fetuin-A. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Cytokeratin-18. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Added at 2016-01-05: Serum Ferritin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit.;Added at 2016-01-05: Serum Adiponectin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit.;Added at 2016-01-05: Serum MCP-1 (Monocyte chemoattractant protein-1. Timepoint: Added at 2016-01-05: Bas	—

Measure

Time frame

Hepatic steatosis. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Ultrasound of liver.;Liver enzymes (ALP, ALT, AST). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum concentration of these enzymes with enzymatic method by kits.;Fasting Blood Sugar (F.B.S.). Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Enzymatic method.;Serum insulin level. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Chemoluminescense.;Insulin resistance. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Calculation of HOMA-IR.;Lipid profile. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Triglyceride, total cholesterol and HDL-cholesterol with spectrophotometry and LDL-cholesterol with Friedewald equation.;Oxidative indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Total antioxidant capacity (TAC) by using spectrophotometry, MDA by using thiobarbituric acid, SOD and GPX activities by using ELIZA kits.;Inflammatory indicators. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum levels of TNF-a? TGF-ß and IL-10 by using ELIZA kits.;Sirtuin-1. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Fetuin-A. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Cytokeratin-18. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: ELIZA kit.;Added at 2016-01-05: Serum Ferritin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit.;Added at 2016-01-05: Serum Adiponectin. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: ELIZA kit.;Added at 2016-01-05: Serum MCP-1 (Monocyte chemoattractant protein-1. Timepoint: Added at 2016-01-05: Bas

—

Secondary

Measure	Time frame
Anthropometric measurements. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Weight and Height by using Seca scale and stadiometer respectively, waist circumference by using tape measure, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters.;Energy and macro-nutrients intake. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: 3-day 24 hours food recall.;Physical activity level. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: International physical activity questionnaire.;Added at 2016-01-05: Body composition (Total body fat, visceral body fat, body water, body bone mass and body muscle mass percentages. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: Bioelectrical impedance analysis machine.;Added at 2016-10-29: Appetite status. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Visual Analogue Scales questionnaire.;Added at 2016-10-29: Subcutaneous abdominal fat thickness. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Ultrasonography.	—

Measure

Time frame

Anthropometric measurements. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Weight and Height by using Seca scale and stadiometer respectively, waist circumference by using tape measure, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters.;Energy and macro-nutrients intake. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: 3-day 24 hours food recall.;Physical activity level. Timepoint: Baseline, 6 and 12 weeks after intervention. Method of measurement: International physical activity questionnaire.;Added at 2016-01-05: Body composition (Total body fat, visceral body fat, body water, body bone mass and body muscle mass percentages. Timepoint: Added at 2016-01-05: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-01-05: Bioelectrical impedance analysis machine.;Added at 2016-10-29: Appetite status. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Visual Analogue Scales questionnaire.;Added at 2016-10-29: Subcutaneous abdominal fat thickness. Timepoint: Added at 2016-10-29: Baseline and 12 weeks after intervention. Method of measurement: Added at 2016-10-29: Ultrasonography.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFarshad Amirkhizi

Nutrition Faculty, Tabriz University of Medical Scienses

amirkhizif@tbzmad.ac.ir+98 41 3335 7581

Outcome results

None listed

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