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Trial registered on ANZCTR
Registration number
ACTRN12613000072718
Ethics application status
Approved
Date submitted
17/01/2013
Date registered
18/01/2013
Date last updated
18/01/2013
Type of registration
Retrospectively registered
Titles & IDs
Public title
The effect of weight cycling on iron status, inflammation and immune function in young, overweight and obese women
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Scientific title
The relationship between body weight and weight cycling on iron status, inflammation and immune function in young overweight and obese women: a cross-sectional study
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Secondary ID [1]
281794
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Nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity
288118
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Condition category
Condition code
Diet and Nutrition
288495
288495
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0
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Obesity
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
This is a cross-sectional study that observed weight cycling history, iron and inflammatory markers at one time point.
Anthropometric data including height, weight, BMI, waist circumference, as well as body composition data including percent body fat, absolute fat mass and lean mass (using both bio-electrical impedance and dual x-ray absorptiometry measurement techniques) were collected.
Self-reported history of weight cycling, weight loss and
attempts at weight loss in the past five years was recorded. Participants were also required to undergo one blood test to measure concentration of iron, inflammatory and immune markers.
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Intervention code [1]
286338
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Not applicable
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Comparator / control treatment
N/A
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Participants will be required to undergo one blood test from which a haematology (including haemoglobin, haematocrit, MCV, MCH, MCHC) and routine iron studies (serum iron, transferrin, transferrin saturation, serum ferritin) will be measured at a nationally accredited pathology laboratory (Laverty Pathology Australia).
Additional plasma will be stored for analysis of inflammatory markers (C-reactive protein, interleukin-6 and tumour necrosis factor-alpha) as well as non-routine iron markers soluble transferrin receptor and hepcidin.
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Assessment method [1]
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Timepoint [1]
288653
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Baseline
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Secondary outcome [1]
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Participants will be required to undergo one blood test from which immune markers (including absolute lymphocyte count, CD3, CD4, CD8, CD19, white blood cells, platelets, neutrophils, basophils, eosinophils) will be measured at a nationally accredited pathology laboratory (Laverty Pathology Australia).
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Assessment method [1]
300701
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Timepoint [1]
300701
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Baseline
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Eligibility
Key inclusion criteria
Body mass index equal to or above 27.5 kg/m2
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Minimum age
18
Years
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Maximum age
25
Years
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Self-report of significant medical conditions (e.g. diabetes mellitus, disorders of the liver (including hemochromatosis) and kidney, autoimmune or metabolic diseases and malignancy) or use of medications that may influence weight, iron or inflammatory status; pregnancy or lactation; vegetarianism; smoking; and previous bariatric surgery. Volunteers reporting iron supplementation or blood donation within three months prior to recruitment were asked to participate only following a three month washout period
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
1/03/2005
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Actual
2/03/2006
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Date of last participant enrolment
Anticipated
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Actual
29/10/2010
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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Royal Prince Alfred Hospital - Camperdown
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Funding & Sponsors
Funding source category [1]
286579
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Commercial sector/Industry
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Name [1]
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Meat and Livestock Australia
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Address [1]
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Level 1, 165 Walker Street, North Sydney NSW 2060
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Country [1]
286579
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Australia
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Primary sponsor type
University
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Name
The University of Sydney
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Address
The University of Sydney
East Street
Lidcombe 2141
NSW
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Country
Australia
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Secondary sponsor category [1]
285363
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Hospital
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Name [1]
285363
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Royal Prince Alfred Hospital
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Address [1]
285363
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Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
NSW
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Country [1]
285363
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
288656
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Sydney South West Area Health Service Human Research Ethics Committee
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Ethics committee address [1]
288656
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Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
Newtown NSW 2042
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Ethics committee country [1]
288656
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Australia
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Date submitted for ethics approval [1]
288656
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Approval date [1]
288656
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Ethics approval number [1]
288656
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HREC/09/RPAH/172
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Summary
Brief summary
This study examines the effect of weight cycling on iron status, inflammation and immune function. The objective is to measure iron levels, inflammation and the immune systems of young women and then investigate how weight cycling can affect these factors. This research study is part of larger trial that is comparing the effectiveness of a red meat based, low fat diet and a white meat based, low fat diet on weight loss, immune function, blood fats, glucose, insulin and iron levels.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Helen O'Connor
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Address
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Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
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Country
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Australia
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Phone
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+61 2 9351 9625
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Fax
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+61 2 9351 9204
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Email
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[email protected]
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Contact person for public queries
Name
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Dr Helen O'Connor
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Address
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Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
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Country
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Australia
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Phone
37135
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+61 2 9351 9625
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Fax
37135
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+61 2 9351 9204
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Email
37135
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[email protected]
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Contact person for scientific queries
Name
37136
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Dr Helen O'Connor
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Address
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Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
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Country
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Australia
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Phone
37136
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+61 2 9351 9625
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Fax
37136
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+61 2 9351 9204
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Email
37136
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[email protected]
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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.
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