Protocol summary

Summary
The objective of this study is to assess the effect of aerobic training with Flax seed supplementation on blood lipids profile and C-Reactive protein in sedentary obese women. Forty five obese/overweight women will participate in the study. The subjects will be randomly assigned to 3 groups (1- Aerobic training plus Flax seed supplementation. 2- Flax seed supplementation. 3- Control ) . The group 1 will participate in a 10-week aerobic training [three times a week, 15-50 min/session and intensity of the exercise program is 50-75% heart rate max (HRmax)]. Blood lipids and C-Reactive protein (ELISA method) will be measured prior to and after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201309303387N4
Registration date: 2013-10-28, 1392/08/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-10-28, 1392/08/06
Registrant information
Name
Abbas Saremi
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 1277 7400
Email address
a-saremi@araku.ac.ir
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2013-05-31, 1392/03/10
Expected recruitment end date
2013-07-01, 1392/04/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of of aerobic training plus Flax seed supplementation on serum lipids and lipoprotein profile and C-reactive protein in sedentary obese women.
Public title
The effect of of aerobic training plus Flax seed supplementation on serum lipids and lipoprotein profile and C-reactive protein in sedentary obese women.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having a stable weight for at least 3 months prior to the study, age more than 30 years, body mass index more than 25, signing informed consent and presence of cardio-pulmonary. Exclusion criteria: Smoking.
Age
From 30 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Sardasht, University of Medical Sciences
City
Arak
Postal code
Approval date
2013-02-08, 1391/11/20
Ethics committee reference number
142-2-91

Health conditions studied

1

Description of health condition studied
Obesity
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
Serum triglyceride
Timepoint
Baseline and after 10 weeks
Method of measurement
Glycerol phosphate oxidase, Enzymatic colorimetric

2

Description
Total cholestrol
Timepoint
Baseline and after 10 weeks
Method of measurement
Enzymatic photometric

3

Description
HDL-cholestrol
Timepoint
Baseline and after 10 weeks
Method of measurement
Enzymatic photometric

4

Description
LDL-cholestrol
Timepoint
Baseline and after 10 weeks
Method of measurement
Friedewald formula

5

Description
C-Reactive protein
Timepoint
Baseline and after 10 weeks
Method of measurement
ELISA assay

Secondary outcomes

empty

Intervention groups

1

Description
Flax seed supplementation gruop: 9 grams/day powder of Flax seed.
Category
Treatment - Drugs

2

Description
Flax seed plus aerobic training gruop: 9 grams/day powder of Flax seed with aerobic training supervised by an exercise physiologist, 15-50 minate/day, 3day/week, for 10 weeks. The training program started at 50% of observed maximal heart rate (HRmax) and gradually increased to 75% of maximal heart rate by week 10. Aerobic training included treadmill walking/running.
Category
Treatment - Drugs

3

Description
The control group will maintaine their lifestyle as usual.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghiasi Hospital
Full name of responsible person
Doctor Saremi Abbas
Street address
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak university
Full name of responsible person
Dr Shavandi
Street address
Pajohesh, Arak university, Shariati street, Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak university
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
Arak University
Full name of responsible person
Dr Abbas Saremi
Position
Exercise physiologist
Other areas of specialty/work
Street address
Department of Physical Education and Sport Science, Arak University
City
Arak
Postal code
Phone
+98 86 1276 0104
Fax
Email
a-saremi@araku.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University
Full name of responsible person
Dr Abbas Saremi
Position
Exercise physiologist
Other areas of specialty/work
Street address
Department of Physical Education and Sport Science, Arak University, Shariati street, Arak
City
Arak
Postal code
Phone
+98 86 1277 7400
Fax
Email
a-saremi@araku.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University
Full name of responsible person
Dr Abbas Saremi
Position
Exercise physiologist
Other areas of specialty/work
Street address
Department of Physical Education and Sport Science, Arak University, Shariati street, Arak
City
Arak
Postal code
Phone
+98 86 1277 7400
Fax
Email
a-saremi@araku.ac.ir
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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