Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000529842
Ethics application status
Approved
Date submitted
18/05/2012
Date registered
18/05/2012
Date last updated
18/05/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Fish Oil, Exercise, and Mediterranean Diet on Metabolic Markers of Inactive Premenopausal Women
Scientific title
Fish Oil, Exercise, and Mediterranean Diet on Metabolic Markers of Inactive Premenopausal Women (FEM)
Secondary ID [1] 280506 0
Nil
Universal Trial Number (UTN)
Trial acronym
FEM
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metabolic Syndrome 286489 0
Inflammation 286490 0
Dyslipidemia 286491 0
Diabetes 286498 0
Obesity 286499 0
Condition category
Condition code
Metabolic and Endocrine 286751 286751 0 0
Diabetes
Diet and Nutrition 286758 286758 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Fish oil supplementation: Consisting of three 1100 mg fish oil capsules per day, for 12 weeks. Each capsule contained 550 mg of eicosapentaenoic acid and docosahexaenoic acid per 1100 mg capsule (YourHealth Group, Australia).
Exercise: Consisted of 20 minutes of high intensity interval exercise (8 s sprint, 12 s recovery) on an electronically braked cycle ergometer for each session three times a week for 12 weeks.
Diet: Participants were asked to eat a low glycemic Mediterranean style diet and complete a food diary before and after the 12-week intervention. No caloric amount was introduced rather a change in the quality of foods consumed was stressed to participants. The FEM women were given an overview of the healthy eating plan prior to commencing the program. Participants were also given recipes, advice, and nutritional information along with a Mediterranean pyramid. After the initial diet sessions, FEM women were given more dietary guidelines throughout the study (every 3 weeks) along with feedback from their previous one-day diet diary and ways to progress towards the recommended Mediterranean diet. Use of a Mediterranean Diet Score (MDS) provided adherence information on a scale of zero to nine; zero represented the least adherent to a Mediterranean diet and nine represented total adherence to a Mediterranean diet. MDS was based on the median values calculated from mean scores for all women in FEM.
For the study as a whole, all 3 components (fish oil, exercise, and Mediterranean diet) were implemented simultaneously over the 12 week period in the randomized intervention group known as FEM.
Intervention code [1] 284878 0
Lifestyle
Intervention code [2] 284879 0
Behaviour
Intervention code [3] 284883 0
Prevention
Comparator / control treatment
They were asked to maintain their normal exercise and dietary habits.
Control group
Active

Outcomes
Primary outcome [1] 287141 0
Decrease risk of metabolic syndrome: lower total and central adiposity measured by either dual energy xray absorptiometry or a Tanita body composition scale, improved triglyceride, total cholesterol, low density lipoprotein, high density lipoproteins, and glucose levels measured by a Cholestech analyzer to detect whole blood levels, and blood pressure values measured by a manual sphygmomanometer. All the above mentioned variables were measured pre to post intervention. Improve hormone and inflammatory concentrations from plasma samples analyzed with High-Sensitivity Enzyme Immunoassays (hs-ELISA) and increase fitness levels assess with a cardiorespiratory fitness test on a cycle ergometer.
Timepoint [1] 287141 0
Pre, 6 and 12 weeks of the intervention
Secondary outcome [1] 297475 0
Improve the quality of the dietary intake through 24 hour dietary recalls analyzed using Foodworks software.
Timepoint [1] 297475 0
Pre, 6 and 12 weeks of the intervention

Eligibility
Key inclusion criteria
Premenopausal, recreationally active but untrained (< 2.5 hours a week of physical activity) overweight or obese (all women except Asian women had a BMI > 25 and < 35 kg/meters squared, Asian women had a BMI >23 and <33 kg/meters squared) women were recruited from a university population.
Minimum age
18 Years
Maximum age
35 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Women were overweight or obese but otherwise healthy. Women were excluded if they had any of the following: diabetes, impaired glucose tolerance (fasting plasma glucose levels above 6.0 mmol/L), hypertension (blood pressure >140/90 mmHg), cardiovascular disease, psychiatric problems, history of alcohol abuse (intake of >500 g/wk in the last year), current or recent (in the past 3 years), smoking, certain medication use, symptoms of chronic or current infection, a chronic inflammatory condition, any thyroid condition, liver disease or malignancy, being pregnant or planning on becoming pregnant during the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants contacted research staff indicating an interest and an informed consent appointment was set up. After all study procedures were explained and written University ethics approved informed consent was complete participants were randomly allocated into one of two groups: fish oil, exercise, Mediet (FEM), or control (CON) by pulling a piece of paper out of a cup labelled FEM or CON.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants pulled a piece of paper out of a cup labelled FEM or CON indicating group allocation.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
NA
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
15/02/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 5310 0
2052

Funding & Sponsors
Funding source category [1] 285268 0
University
Name [1] 285268 0
University of New South Wales
Country [1] 285268 0
Australia
Primary sponsor type
Individual
Name
Stephen H. Boutcher, Ph.D.
Address
Faculty of Medicine
University New South Wales
Sydney, NSW 2052
Country
Australia
Secondary sponsor category [1] 284132 0
Individual
Name [1] 284132 0
Judith Freund, MBBS, FRACP, DDU, ANZAPNM, FRCP
Address [1] 284132 0
Faculty of Medicine
University New South Wales
Sydney, NSW 2052
Country [1] 284132 0
Australia
Other collaborator category [1] 260804 0
Individual
Name [1] 260804 0
Winnie Siu, MBBS, M.P.H
Address [1] 260804 0
27 Gubbuteh Road
Little Bay, NSW 2036
Country [1] 260804 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287284 0
University of New South Wales Human Research Ethics Committee
Ethics committee address [1] 287284 0
Ethics committee country [1] 287284 0
Australia
Date submitted for ethics approval [1] 287284 0
07/11/2006
Approval date [1] 287284 0
11/01/2007
Ethics approval number [1] 287284 0
06293

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34190 0
Address 34190 0
Country 34190 0
Phone 34190 0
Fax 34190 0
Email 34190 0
Contact person for public queries
Name 17437 0
Sarah L. Dunn, Ph.D.
Address 17437 0
University of La Verne
Movement and Sports Science Department
1905 Third Street
La Verne, CA 91750
Country 17437 0
United States of America
Phone 17437 0
+1, 909, 593, 3511
Fax 17437 0
+1, 909, 392, 2760
Email 17437 0
[email protected]
Contact person for scientific queries
Name 8365 0
Sarah L. Dunn, Ph.D.
Address 8365 0
University of La Verne
Movement and Sports Science Department
1905 Third Street
La Verne, CA 91750
Country 8365 0
United States of America
Phone 8365 0
+1, 909, 593, 3511
Fax 8365 0
+1, 909, 392, 2760
Email 8365 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.