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Effect of L-carnitine supplementation and modrate aerobic training on some serum indices of oxidative stress, inflammation and insulin resistance in obese women

Protocol summary

Summary
The objective of this randomized double-blind placebo controlled trial is to investigate the effect of L-carnitine supplementation and modrate aerobic training on the metabolic outcomes of obesity in obese women. Subjects with obesity will be recruited from exercise clubs in Tabriz including 44 individuals. Subjects will be randomly assigned to receive either 250mg L-carnitine oral tablet or corn starch placebo tablets for 60 days. In training groups subjects will be participate in moderate aerobic training 3 times a week (24 sessions) for 8 weeks. Anthropometric measurements (weight, height, waist and hip circumference, waist to hip ratio, body fat percentage %), VO 2 max, biochemical parameters (lipid profile including total cholesterol, LDL and HDL cholesterol and triglyceride concentrations, fasting glucose and insulin level, IL-6 ,IL-10 ,hs-CRP,TAC, MDA levels), concentrations of serum L-carnitine and dietary data obtained from 3-day food records will be measured before and after treatment and compared between groups.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901193664N1
Registration date: 2010-07-04, 1389/04/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-07-04, 1389/04/13
Registrant information
Name
Maryam Rafraf
Name of organization / entity
Tabriz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 7580
Email address
rafrafm@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice-chancellor for Research, Tabriz University Of Medical Sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2009-11-22, 1388/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of L-carnitine supplementation and modrate aerobic training on some serum indices of oxidative stress, inflammation and insulin resistance in obese women
Public title
L-carnitine supplementation and moderate aerobic training in obese women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: women with BMI ≥ 30, %BF≥30, age 20-50 years old. Exclusion criteria: any disease that influence metabolic parameters in this trial (liver, cardiovascular, kidney or gastrointestinal diseases, hypo/hyper thyroidism, orthopedic problems, Romatoid artritis, diabetes, hypertension), pregnancy, receiving any vitamin or mineral supplements, people who have usual aerobic training program (more than 3 times a week, 2 hours every time), any special diet.
Age
From 20 years old to 50 years old
Gender
Female
Phase
2-3
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
Factorial
Other design features

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University Of Medical Sciences
Street address
Attare Neishaboori Avenue, Golgasht Street
City
Tabriz
Postal code
Approval date
2009-10-11, 1388/07/19
Ethics committee reference number
5/4/5478

Health conditions studied

1

Description of health condition studied
obesity
ICD-10 code
E66.0
ICD-10 code description
Obesity due to excess calories

Primary outcomes

1

Description
L-carnitine serum value
Timepoint
Baseline and at the end of intervention
Method of measurement
kit & spectrophotometry

Secondary outcomes

1

Description
Fasting serum insulin values & Insulin resistance index
Timepoint
Baseline and at the end of intervention
Method of measurement
chemiluminescance & HOMA formula

2

Description
Fasting serum glucose values
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic method, automatic analyzer

3

Description
Fasting srum lipid profile (LDL,HDL,total cholesterol,TG)
Timepoint
Baseline and at the end of intervention
Method of measurement
Enzymatic method, with special kits for assessing TG, HDL, total cholestrol and Friedewald equation for assessing LDL cholestrol

4

Description
Serum inflammatory values (IL-6 ,IL-10, hs-CRP)
Timepoint
Baseline and at the end of intervention
Method of measurement
hs-CRP assess with immunotorbidometric method andIL-6& IL-10 with elayza method

5

Description
serum indices of oxidative stress (TAC,MDA)
Timepoint
Baseline and at the end of intervention
Method of measurement
TAC with special kits, MDA with chemical-calorimetric & reaction with tiobarbitoric acid

6

Description
Antropometric indicators (weight, height, BMI, Waist circumference, hip circumference, Waist to Hip Ratio)
Timepoint
Baseline and at the end of intervention
Method of measurement
physical exam

7

Description
Measurement of Peak Aerobic Capacity - VO2max
Timepoint
Baseline and at the end of intervention
Method of measurement
With Rockport Walking Test

8

Description
Body Fat %
Timepoint
Baseline and at the end of intervention
Method of measurement
ACSM formula and measurement of skin fold thickness according to three site measurements

Intervention groups

1

Description
Only Placebo, 8 tablets a day for 8 weeks (insoluble starch)
Category
Placebo

2

Description
moderate aerobic training, 3 times a week (24 sessions, every session 45 minutes) for 8 week plus Placebo
Category
Lifestyle

3

Description
L-carnitine, 8 tablets daily for 8 weeks (each tablet contains 250 mg of L-carnitine) without aerobic training
Category
Treatment - Drugs

4

Description
L-carnitine, 8 tablets daily for 8 weeks (each tablet contains 250 mg of L-carnitine) plus moderate aerobic training, 3 times a week (24 sessions, every session 45 minutes) for 8 week
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Exercise clubs in Tabriz
Full name of responsible person
Mina Karimi
Street address
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tabriz Nutrition Research Center, Tabriz University of Medical Science
Full name of responsible person
Maryam Rafraf
Street address
Health and Nutrition school, Attare Neishabouri avenue, Golgasht street
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Tabriz Nutrition Research Center, Tabriz University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Mina Karimi
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 1442 1398
Fax
Email
mina.karimi33@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mina Karimi
Position
MS student in Nutrition
Other areas of specialty/work
Street address
Health and Nutrition school, Attare Neishabouri Avenue, Golgasht street
City
Tabriz
Postal code
Phone
+98 41 1442 1398
Fax
Email
mina.karimi33@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Mina Karimi
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
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Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
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