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Effect of 10-week progressive resistance training and ginger herbal Medicine intake on blood lipids Profiles, oxidative and inflammatory markers in obese men

Protocol summary

Summary
Aim: This study will conduct to determine the effect of 10-week progressive resistance training and ginger supplementation on physical fitness, body composition, lipid profiles, oxidative stress and inflammatory markers in obese men. Methods: Thirty-two obese male (aged 18–32 years, BMI≥ 30 Kg/m2) in a randomized double-blind design, will allocate equally into four homogeneous groups: PL (without training plus Dextrose intake); RTPL (training plus Dextrose); GI (without training plus Ginger intake), and RTGI (training plus ginger intake). The subjects will intake 1 g/d ginger (GI and RTGI) or Dextrose (PL and RTPL) during resistance training protocol (3 sessions/week; 8 exercises/session) for 10 weeks. In both groups, physical fitness (maximal isometric strength, explosive power, and Flexibility of lower limb), body composition (BMI, Fat%, FFM, WHR, WC), blood lipid profile, oxidative stress (malondialdehyde and antioxidant capacity: MDA & TAC), and inflammatory indicators (Peripheral blood leukocyte count; C-reactive protein: CRP; Interleukin-6: IL6; Interleukin-10: IL-10; Adiponectin; and homocysteine: tHcy) along with blood Testosterone and Cortisol concentration will determine 48 hours before and after supplementation and training protocol.

General information

Acronym
GingerTra2011
IRCT registration information
IRCT registration number: IRCT201008304663N1
Registration date: 2012-08-05, 1391/05/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-08-05, 1391/05/15
Registrant information
Name
Afshar Jafari
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 1339 3251
Email address
ajafari@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
The Research will funded by Mahabad Branch Islamic Azad University.
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-09-23, 1389/07/01
Actual recruitment start date
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Actual recruitment end date
empty
Trial completion date
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Scientific title
Effect of 10-week progressive resistance training and ginger herbal Medicine intake on blood lipids Profiles, oxidative and inflammatory markers in obese men
Public title
Effect of training and ginger on obesity
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria: Males; non-athletes; Obese; aged 18-35 years; BMI >30 Kg/m2; aerobic power < 45 ml/kg/min; without any anti-inflammatory and medical drugs such as caffeine>100 mg/day (during 6 months prior to the study). Exclusion criteria: Smoking; chronic diseases; injuries; and uncontrolled intake of oxidative supplements; uncontrolled intake of anti-inflammatory drugs and stimulants (during the period).
Age
From 18 years old to 32 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
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
Golgasht St. Daneshgah St. Tabriz, East Azerbaijan, Iran.
City
Tabriz
Postal code
Approval date
2010-08-30, 1389/06/08
Ethics committee reference number
8928

Health conditions studied

1

Description of health condition studied
Supplementation and Training combination for obesity treatment
ICD-10 code
E66
ICD-10 code description
Obesity

Primary outcomes

1

Description
Serum Malondialdehyde level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by thiobarbituric acid reactive substance (TBARS) and spectrophotometer.

2

Description
Serum Total antioxidant capacity
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by FRAP method.

3

Description
Serum cortisol level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by radioimmunoassay.

4

Description
Peripheral blood lipids profile
Timepoint
48 hours before and after a 10-week period.
Method of measurement
The lipid profile will determine by serum levels of total cholesterol (TC), high-density cholesterol (HDL-C), low-density cholesterol (LDL-C) and triglycerides (TG) using the enzymatic method.

5

Description
Serum Adiponectin level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

6

Description
Serum tumor necrosis factor alpha (TNF-alpha) level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

7

Description
Serum interleukin-6 (IL-6) level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

8

Description
Serum C-reactive protein level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by immunoturbidometric assay.

9

Description
Serum interleukin-10 (IL-10) level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

10

Description
Fasting serum total homocysteine (tHcy)
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determined by enzymatic commercial kits.

11

Description
Serum testosterone level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by radioimmunoassay.

12

Description
Peripheral blood leukocyte count
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by automatic analyzer.

Secondary outcomes

1

Description
Serum Growth Hormone Level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by radioimmunoassay.

2

Description
Complete blood count (CBC)
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by automatic analyzer.

3

Description
Fasting Blood Sugar (FBS)
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by the enzymatic method.

4

Description
Insulin resistance
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by HOMA formula.

5

Description
Body fat%
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine with Skin-fold test (caliper and ACSM’s Formula).

6

Description
Hand grip strength
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by Dynamometry.

7

Description
Lower limb maximal isometric strength
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by Dynamometry.

8

Description
One Repetition Maximum in eight resistance exercises
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by the Brzycki prediction equation.

9

Description
Lower limb flexibility
Timepoint
48 hours before and after a 10-week period.
Method of measurement
Sit and reach test (wells SRT)

10

Description
Lower limb explosive power
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by Sargent vertical jump test.

11

Description
Waist circumstance (WC)
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by flexible tape.

12

Description
Waist-Hip Ratio (WHR)
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will Measure by a flexible tape and the ratio of waist circumference to the hip circumference.

13

Description
Serum Leptin level
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

14

Description
Serum ghrelin levels
Timepoint
48 hours before and after a 10-week period.
Method of measurement
It will determine by ELISA methods with commercial kits.

Intervention groups

1

Description
The subjects in RTPL group (training plus Plecbo) will intake 1 g/d Dextrose during 10-week resistance training (3 sessions/week; 8 exercises/session, with 50-85% 1RM).
Category
Other

2

Description
The subjects in GI group (Supplement without training) will intake 1 g/d Ginger for 10 weeks.
Category
Treatment - Drugs

3

Description
The subjects in RTGI group (training plus supplement) will intake 1 g/d ginger during 10-week resistance training (3 sessions/week; 8 exercises/session, with 50-85% 1RM).
Category
Other

4

Description
The subjects in PL group (Placebo without training) will intake 1 g/d Dextrose for 10 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University (Mahabad Branch)
Full name of responsible person
Dr Sirvan Atashak
Street address
Department of Physical Education and Sports Sciences, Mahabad Branch, Islamic Azad University, Kuy-e-Daneshgah, Mahabad, West Azerbaijan, Iran.
City
Mahabad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University (Mahabad Branch)
Full name of responsible person
Dr Mahmod Poor Yousef
Street address
Mahabad Branch Islamic Azad University, Kuy-e-Daneshgah, Mahabad, West Azerbaijan,Iran.
City
Mahabad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University (Mahabad Branch)
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Tabriz
Full name of responsible person
Dr Afshar Jafari
Position
PhD/Associate Professor of Molecular Exercise Physiology
Other areas of specialty/work
Street address
Faculty of Physical Education & Sports Sciences, University of Tabriz, 29 Bahman Avenue, Tabriz, East Azerbaijan, Iran
City
Tabriz
Postal code
Phone
+98 41 1339 3251
Fax
+98 41 1335 6008
Email
ajafari@tabrizu.ac.ir
Web page address

Person responsible for updating data

Contact

Sharing plan

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