Protocol summary

Summary
The objective of this single blind, placebo-controlled, randomized intervention trial is to determine the effects of dietary 600 mg/day gamma oryzanol supplementation during a 9-week resistance training program on altering lipid profile, anabolic/catabolic hormones, circulating binding proteins and anthropometric measures of young males during resistance training. Thirty two (32) eligible males with no continuous resistance training experience during six months before the study participation, with age 18-24 years were selected for the study and were randomized into two groups (either 600 mg of gamma oryzanol or lactose in the form of capsules). Prior to the study commencement, subjects’ squat 1 Repetition Maximum (1RM) was determined by means of 1RM strength tests on the regular leg curl and bench press machine, which was repeated on the last day of study. The main inclusion criteria were including having no previous continuous resistance training (as having resistance training for at least 20 minutes 2 to 3 times per week without stopping) during last 6 months before the study commencement; being males and age between 18-30. The main exclusion criteria consisted of: A history of cardiovascular disease; Lactose intolerance; Diabetes mellitus; Cancer; Hypertension; Chronic obstructive pulmonary disease; Psychiatric disease; Any other serious life-threatening illness that required regular medical treatment; Alcohol intake of 15 drinks or more per week or at least 30 g/d; <4d/week of recommended resistance exercise; <80% of provided supplement or placebo capsules; Smokers, or tobacco product consumers; Taking any weight lose drug or participating in any weight loss program or changing their diets for example vegetarian diet; Anti-inflammatory drugs, hormones supplements or any other supplements before (for a minimum of six months) or during the study period; Concurrent participation in other physical or exercise modalities. The intervention under study was supervised resistance training was performed four times a week, performing three sets (consisting of 6–12 repetitions) per exercise with three minutes rest, for a period of 9 weeks for each participant, accompanied with the consumption of supplement or placebo. At the study commencement in two times, before and after the acute resistance exercise, and at the end of the 9-week and 24 hours after the last resistance exercise performance, blood sampling were taken following 10-12 hour fast. Also, anthropomorphic measurements and physical performance were obtained before and after accomplishment of the study.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013120715694N1
Registration date: 2014-05-05, 1393/02/15
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-05-05, 1393/02/15
Registrant information
Name
Saghar Eslami
Name of organization / entity
UNSW
Country
Australia
Phone
0061451817195
Email address
s.eslami@student.unsw.edu.au
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Putra Malayisa
Expected recruitment start date
2010-02-10, 1388/11/21
Expected recruitment end date
2010-04-17, 1389/01/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of gamma oryzanol supplementation on lipid profile, anabolic/catabolic hormones, circulating binding proteins and anthropometric changes in young males during resistance training
Public title
Gamma oryzanol Supplementation Study
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: having no previous continuous resistance training (having resistance training for at least 20 minutes 2 to 3 times per week without stopping) during last 6 months before the study commencement; being males and age between 18-30; Exclusion criteria: A history of cardiovascular disease; Lactose intolerance, Diabetes mellitus, Cancer, Hypertension, Chronic obstructive pulmonary disease, Psychiatric disease; Any other serious life-threatening illness that required regular medical treatment; Alcohol intake of 15 drinks or more per week or at least 30 g/d <4d/week of recommended resistance exercise; <80% of provided supplement or placebo capsules; Smokers, or tobacco product consumers; Taking any weight lose drug or participating in any weight loss program or changing their diets for example vegetarian diet; Anti-inflammatory drugs, hormones supplements or any other supplements before (for a minimum of six months) or during the study period; Concurrent participation in other physical or exercise modalities
Age
From 18 years old to 30 years old
Gender
Male
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical research ethic committee , University of Putra Malaysia
Street address
Faculty of Medical Science
City
selangor
Postal code
Approval date
2010-01-12, 1388/10/22
Ethics committee reference number
UPM/FPSK/T7-MJKEthicaPer/F01(JPD-OKT(09)68)

Health conditions studied

1

Description of health condition studied
improving Anabolic and catabolic hormones alterations and blood lipid profile as well improving anthropometric measurements following resistance exercise in young males
ICD-10 code
Z10
ICD-10 code description
Routine general health check-up of defined subpopulation

Primary outcomes

1

Description
lipid profile
Timepoint
9 weeks
Method of measurement
blood analysis

2

Description
Anabolic and catabolic hormones
Timepoint
9 weeks
Method of measurement
blood analysis

Secondary outcomes

1

Description
Anthropometric changes
Timepoint
9 weeks
Method of measurement
Anthropocentric measurements

Intervention groups

1

Description
Supplement group: After first blood sampling, all the subjects performed acute heavy resistance protocol (AHRE) consisting of 6 sets of 10 repetitions with 80% 1RM, followed by second blood sampling. Each subjects consumed 600mg gamma oryzanol as supplement group for 9 weeks.
Category
N/A

2

Description
Placebo group: After first blood sampling, all the subjects performed acute heavy resistance protocol (AHRE) consisting of 6 sets of 10 repetitions with 80% 1RM, followed by second blood sampling. Each subjects consumed 600mg lactose as placebo (control) group for 9 weeks.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Faculty of Sport Sciences, University of Isfahan
Full name of responsible person
Saghar Eslami
Street address
Faculty of Sport Sciences, University of Isfahan, Hezar-Jerib Ave,
City
Isfahan,

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, University of Putra Malaysia
Full name of responsible person
Associate Professor Norhaizan Mohd. Esa
Street address
Faculty of Medicine and Health Sciences, University of Putra Malaysia, Jalan Jasmin,
City
Serdang,
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, University of Putra Malaysia
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
University of Putra Malaysia
Full name of responsible person
Saghar Eslami
Position
PhD
Other areas of specialty/work
Street address
Faculty of Medicine and Health Sciences, University of Putra Malaysia, Jalan Jasmin,
City
Serdang,
Province
Selangor, Darul Ehsan
Postal code
43400
Phone
0061451817195
Fax
Email
eslami_sr@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Saghar Eslami
Position
PhD
Other areas of specialty/work
Street address
Faculty of Medicine and Health Sciences, University of Putra Malaysia, Jalan Jasmin,
City
Serdang,
Province
Selangor, Darul Ehsan
Postal code
43400
Phone
0061451817195
Fax
Email
eslami_sr@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Putra Malaysia
Full name of responsible person
Saghar Eslami
Position
PhD
Other areas of specialty/work
Street address
Faculty of Medicine and Health Sciences, University of Putra Malaysia, Jalan Jasmin,
City
Serdang
Province
Selangor, Darul Ehsan
Postal code
43400
Phone
0061451817195
Fax
Email
Web page address

Sharing plan

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