Trial Review

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The ANZCTR now automatically displays published trial results and simplifies the addition of trial documents such as unpublished protocols and statistical analysis plans.

These enhancements will offer a more comprehensive view of trials, regardless of whether their results are positive, negative, or inconclusive.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 281794 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overweight and obesity 288118 0
Condition category
Condition code
Diet and Nutrition 288495 288495 0 0
Obesity

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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.
Intervention code [1] 286338 0
Not applicable
Comparator / control treatment
N/A
Control group
Uncontrolled

Outcomes
Primary outcome [1] 288653 0
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.
Timepoint [1] 288653 0
Baseline
Secondary outcome [1] 300701 0
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).
Timepoint [1] 300701 0
Baseline

Eligibility
Key inclusion criteria
Body mass index equal to or above 27.5 kg/m2
Minimum age
18 Years
Maximum age
25 Years
Sex
Females
Can healthy volunteers participate?
No
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

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/03/2005
Actual
2/03/2006
Date of last participant enrolment
Anticipated
Actual
29/10/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 426 0
Royal Prince Alfred Hospital - Camperdown

Funding & Sponsors
Funding source category [1] 286579 0
Commercial sector/Industry
Name [1] 286579 0
Meat and Livestock Australia
Country [1] 286579 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney
East Street
Lidcombe 2141
NSW
Country
Australia
Secondary sponsor category [1] 285363 0
Hospital
Name [1] 285363 0
Royal Prince Alfred Hospital
Address [1] 285363 0
Royal Prince Alfred Hospital
Missenden Road
Camperdown 2050
NSW
Country [1] 285363 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288656 0
Sydney South West Area Health Service Human Research Ethics Committee
Ethics committee address [1] 288656 0
Research Development Office
RPAH Medical Centre
Suite 210A, 100 Carillon Avenue
Newtown NSW 2042
Ethics committee country [1] 288656 0
Australia
Date submitted for ethics approval [1] 288656 0
Approval date [1] 288656 0
Ethics approval number [1] 288656 0
HREC/09/RPAH/172

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 37134 0
Dr Helen O'Connor
Address 37134 0
Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
Country 37134 0
Australia
Phone 37134 0
+61 2 9351 9625
Fax 37134 0
+61 2 9351 9204
Email 37134 0
[email protected]
Contact person for public queries
Name 37135 0
Helen O'Connor
Address 37135 0
Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
Country 37135 0
Australia
Phone 37135 0
+61 2 9351 9625
Fax 37135 0
+61 2 9351 9204
Email 37135 0
[email protected]
Contact person for scientific queries
Name 37136 0
Helen O'Connor
Address 37136 0
Discipline of Exercise and Sport Science
Faculty of Health Sciences
The University of Sydney
P.O. Box 170
Lidcombe NSW 1825
Country 37136 0
Australia
Phone 37136 0
+61 2 9351 9625
Fax 37136 0
+61 2 9351 9204
Email 37136 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

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