The present study is a double blind randomized controlled trial. The purpose of this study is to evaluate the effect of omega 3 supplement along with lifestyle modification including exercise and healthy nutrition on anthropometric indices and VO2max. Fifty overweight women with age between 20 to 45 years and sedentary lifestyle who referred to obesity clinic of Imam Khomeini Hospital will be recruited to the study. Fifty subjects will be divided randomly into two groups. Both groups receive healthy nutrition education and exercise program including 150 minutes aerobic exercise per week with moderate intensity on lactate threshold. In addition, intervention group receive one omega 3 capsule (1250 mg) daily and control group receive placebo capsule for 8 weeks. In the beginning of the study, weight, abdominal circumference, percentage body fat and maximal oxygen consumption with exercise test on treadmill are assessed. The assessments will be repeated at the 4th and 8th weeks of the study again.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201504267903N4
Registration date:2015-05-08, 1394/02/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-05-08, 1394/02/18
Registrant information
Name
Zahra Alizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2282
Email address
z_alizadeh@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-05-05, 1394/02/15
Expected recruitment end date
2015-07-06, 1394/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of omega-3 supplementation with lifestyle modification on anthropometric indices and VO2max in overweight women
Public title
Weight loss and omega 3
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: female sex; age between 20-45 years; no history of disease or musculoskeletal problems; no history of using drugs or supplements; no history of significant weight reduction over the past 6 months; sedentary lifestyle. Exclusion criteria: pregnancy; musculoskeletal pain with exercise.
Age
From 20 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Postal code
Approval date
2015-04-18, 1394/01/29
Ethics committee reference number
93-04-30-27247-145306
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
Weight loss
Timepoint
Beginning of the study, Day 28, Day 56
Method of measurement
Seca Medical Scale according to kilogram
Secondary outcomes
1
Description
Increasing VO2 max
Timepoint
Beginning of the study, Day 56
Method of measurement
Exercise test on treadmill according to VO2 max/liter
Intervention groups
1
Description
Intervention group: Prescription one capsule of omega 3 (1250 mg) per day, healthy nutrition and moderate intensity aerobic exercise within 8 weeks
Category
Treatment - Drugs
2
Description
Control group: Prescription healthy nutrition and moderate intensity aerobic exercise within 8 weeks
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy of Chancellor for Research of Tehran University of Medical Sciences
Full name of responsible person
Hajar Moammaee
Street address
Tehran University of Medical Sciences, Ghods St., Keshavarz Blvd.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Chancellor for Research of Tehran University of Medical Sciences
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
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor of Sports Medicine
Other areas of specialty/work
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor of Sports Medicine
Other areas of specialty/work
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Zahra Alizadeh
Position
Assistant Professor of Sports Medicine
Other areas of specialty/work
Street address
No7, Opposite of Shariati Hospital, Ale-Ahmad Highway, Tehran.
City
Tehran
Postal code
Phone
+98 21 6119 2282
Fax
Email
z_alizadeh@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)