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
This randomized double blind placebo controlled trial study design with aim to determine 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 (NAFLD) receiving 400IU vitamin E. According to inclusion and exclusion criteria, 44 patients with NAFLD will be recruited to the study. Informed written consent form and personality questionnaire will be filled for all of the patients. Participants will be randomly allocated to intervention and control groups using blocked randomization method. Subjects in Intervention and control group will receive 2 capsules alpha-lipoic acid (each containing 600mg, daily 1200mg) or 4 capsules of placebo, respectively for 12 weeks. Anthropometric measurements including weight, height, waist circumference and body mass index (BMI) will be evaluated on baseline and again after the intervention. Furthermore, dietary intake and physical activity status will be determined by 3-day 24-hours food recall questionnaire (one for the weekend and two for weekdays) and physical activity record at baseline and at the end of weeks 6 and 12.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201511143320N12
Registration date:2015-12-24, 1394/10/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-24, 1394/10/03
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
Nutrition Research Center, Tabriz University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
The effect of oral alpha-lipoic acid supplement on nonalcoholic fatty liver disease patients
Purpose
Supportive
Inclusion/Exclusion 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
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Research Ethics Committee of Tabriz University of Medical Sciences
Street address
Attar Neyshabori Street, Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2015-12-09, 1394/09/18
Ethics committee reference number
TBZMED.REC.1394.786
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver disease
ICD-10 code
K 76
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
Hepatic steatosis
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Ultrasound of liver
2
Description
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
3
Description
Fasting Blood Sugar (F.B.S.)
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Enzymatic method
4
Description
Serum insulin level
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Chemoluminescense
5
Description
Insulin resistance
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Calculation of HOMA-IR
6
Description
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
7
Description
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
8
Description
Inflammatory indicators
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
Serum levels of TNF-α، TGF-β and IL-10 by using ELIZA kits
9
Description
Sirtuin-1
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA kit
10
Description
Fetuin-A
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA kit
11
Description
Cytokeratin-18
Timepoint
Baseline and 12 weeks after intervention
Method of measurement
ELIZA kit
12
Description
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
13
Description
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
14
Description
Added at 2016-01-05: Serum MCP-1 (Monocyte chemoattractant protein-1
Timepoint
Added at 2016-01-05: Baseline and 12 weeks after intervention
Method of measurement
Added at 2016-01-05: ELIZA kit
15
Description
Added at 2016-01-05: Serum IL-6
Timepoint
Added at 2016-01-05: Baseline and 12 weeks after intervention
Method of measurement
Added at 2016-01-05: ELIZA kit
16
Description
Added at 2016-10-29: Irisin
Timepoint
Added at 2016-10-29: Baseline and 12 weeks after intervention
Method of measurement
Added at 2016-10-29: ELIZA kit
17
Description
Added at 2016-10-29: Plasminogen Activator Inhibitor Factor - 1 (PAI-1
Timepoint
Added at 2016-10-29: Baseline and 12 weeks after intervention
Method of measurement
Added at 2016-10-29: ELIZA kit
18
Description
Added at 2016-10-29: Leptin
Timepoint
Added at 2016-10-29: Baseline and 12 weeks after intervention
Method of measurement
Added at 2016-10-29: ELIZA kit
Secondary outcomes
1
Description
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
2
Description
Energy and macro-nutrients intake
Timepoint
Baseline, 6 and 12 weeks after intervention
Method of measurement
3-day 24 hours food recall
3
Description
Physical activity level
Timepoint
Baseline, 6 and 12 weeks after intervention
Method of measurement
International physical activity questionnaire
4
Description
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
5
Description
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
6
Description
Added at 2016-10-29: Subcutaneous abdominal fat thickness
Timepoint
Added at 2016-10-29: Baseline and 12 weeks after intervention