Trial from ANZCTR


Trial ID ACTRN12613000714785
Trial Status: Registered
Date Submitted: 21/06/2013
Date Registered: 28/06/2013
Prospectively registered

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Public title Hidden fat in young New Zealand women – what are the metabolic risk and predictive factors?
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format To investigate whether different body fat profiles (hidden versus apparent) of young (16-45 year old) New Zealand European, Maori and Pasifika women are associated with an increased metabolic disease risk, and whether dietary and physical activity patterns are predictors of these body fat profiles and associated with the expression of microRNAs related to energy expenditure/storage.
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Secondary ID [1] 282714 0
Nil known
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UTN Nil
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Trial acronym Women’s EXPLORE study –
“EXamining Predictors Linking Obesity Related Elements”
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Health condition(s) or problem(s) studied:
Obesity 289430 0
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Risk factors for metabolic syndrome, Type 2 Diabetes Mellitus, Cardiovascular Disease 289431 0
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Condition category: Condition code:
Diet and Nutrition Obesity
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Metabolic and Endocrine Metabolic disorders
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Cardiovascular Coronary heart disease
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289811 289811 0 0

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Descriptions of intervention(s) / exposure A comparative cross-sectional study design will be used to develop different body composition profiles in New Zealand women of three ethnicities (NZ European, Maori, Pasifika). The exposure relevant in this study is total and regional body composition which will inform their belonging to a specific profile. Three main body composition profile groups will be explored:
“Normal weight/fat” group – normal BMI (<25), normal BF% (>/=22%,<30);
“Hidden Fat” group – normal BMI (<25), high BF% (>/=30%);
“Overweight, Overfat” group – high BMI (>/=25), high BF% (>/=30%).

The association between body composition profiles and metabolic risk factors will be determined. Predictors of body composition profiles that will be explored include: dietary patterns, physical activity patterns, micro RNA expression, taste perception, eating behaviour.

In total, participants will spend about 3 hours on this project, including all 3 stages over a time frame of about one month. More specifically:
Stage 1 (screening)- about 15-30 minutes. If recruited, participants will be booked for a Stage 2 - research visit to collect data. Each visit will take about 1.5 - 2 hours for blood sampling, blood pressure assessment, anthropometric measurements, dietary questionnaires, taste testing and guidelines for stage 3.
For stage 3, participants will need to wear an accelerometer for the seven days just after their visit. This will involve daily use of the apparatus, but no additional time required. At the end of seven days, they will need about 30-60minutes to complete questionnaires.


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Intervention Code:
Not applicable - Observational study 287376 0
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Comparator / control treatment Comparing the “hidden fat” body composition profile with the other two body composition profiles namely the “normal weight/fat” and “overweight/fat” body composition profiles.
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Control group Uncontrolled
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Primary Outcome: Investigating the association between body composition profiles and markers of metabolic risk.
Body composition will be assessed using Bioelectrical impedance (BIA) for screening and stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA) for body composition. Blood samples will be analysed for metabolic markers (e.g. glucose, insulin, HbA1c, leptin), serum lipid profiles, inflammatory markers (e.g. hs-CRP, IL-6, IL-10 and TNF-a).
289845 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 289845 0
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Primary Outcome: Investigating dietary and physical activity patterns as predictive factors associated with body composition profiles.
Dietary analysis will include a food frequency questionnaire (FFQ), a dietary diversity and food habits questionnaire (DDQ), Three Factor Eating Behaviour Questionnaire, and a simple sweet and fat taste test using the ‘sip and spit’ technique to assess perceived intensity and hedonic ratings on a labelled scale. Physical activity will be assessed using accelerometer data (physical activity counts and metabolic equivalents (METs) and the International Physical Activity Questionnaire (IPAQ). Body composition will be assessed using Bioelectrical impedance (BIA) for screening and stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA) for body composition.
289846 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 289846 0
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Primary Outcome: Investigating miRNA expression related to energy expenditure/storage as a predictive factor associated with body composition profiles.
RNA will be extracted from plasma and miRNA species will be measured using our published techniques (AP Russell et al 2012). Body composition will be assessed using Bioelectrical impedance (BIA) for screening and stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA) for body composition.
289847 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 289847 0
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Secondary Outcome: Investigating associations/interactions between dietary and physical activity patterns and miRNA expression and how this may modulate the odds of having a specific body composition profile.
Dietary analysis (FFQ, DDQ TFEQ) and physical activity (accelerometer data (physical activity counts and METs) and the IPAQ. RNA will be extracted from plasma and miRNA species will be measured using our published techniques (AP Russell et al 2012). Body composition will be assessed using stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA).
303372 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 303372 0
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Secondary Outcome: Investigating taste perceptions as a predictive factor associated with the different body composition profiles.
A simple sweet and fat taste test using the ‘sip and spit’ technique to assess perceived intensity and hedonic ratings on a labelled scale.
Body composition will be assessed using stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA).
303373 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 303373 0
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Secondary Outcome: Investigating eating behaviour and habits as predictive factors associated with the different body composition profiles.
Dietary analysis (FFQ, DDQ TFEQ) and a simple sweet and fat taste test using the ‘sip and spit’ technique to assess perceived intensity and hedonic ratings on a labelled scale. Body composition will be assessed using stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA).
303374 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 303374 0
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Secondary Outcome: Investigating nutrient intake as a predictive factor associated with the different body composition profiles.
Dietary analysis (FFQ, DDQ TFEQ) and physical activity (accelerometer data (physical activity counts and METs) and the IPAQ. Body composition will be assessed using stadiometers, Lufkin measuring tapes, air displacement plethysmography (BodPod) and dual-energy X-ray absorptiometry (DXA).
303375 0
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Timepoint: This study will be conducted as a cross-sectional comparative designed study. 303375 0
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Key inclusion criteria Inclusion criteria will be age (16 to 45 years), post-menarche or pre-menopausal (as defined by a continuous regular menstrual cycle for the past one complete year), and ethnicity (being of NZ European, Maori, or Pasifika ethnicity as defined by at least one parents being from the same ethnicity and self-identification (Statistics NZ, 2006)).
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Minimum age 16 Years
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Maximum age 45 Years
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Gender Females
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Healthy volunteers? Yes
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Key exclusion criteria Exclusion criteria include pregnancy, lactation, and presence of any illness.
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Study type Observational
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Patient registry False
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Target follow-up duration  
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Purpose Screening
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Duration Cross-sectional
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Selection Defined population
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Timing Both
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Statistical Methods/Analysis Sample size calculation is based on ANOVA test. A total sample size of 225 women (75 per profile group) per ethnic group will provide 80% power at significance levels of 0.05 to detect a medium effect size f of 0.25 (G*Power 3.1.2). Thus, a total of 675 women will be recruited. For the logistic regression analysis, to detect an odds ratio (OR, two-tailed) of 2 (twice the risk), a total sample size of 225 will provide 98% power at 5% significance. Based on our pilot study that showed a prevalence of 21% of women having a “hidden fat profile”, a sample of ~1140 women will have to be screened (380 per ethnicity) to find ~75 women per body composition profile group.
Primary statistical analyses will involve ANOVA tests comparing body composition profile groups regarding metabolic risk markers and dietary and physical activity patterns; logistic regression analysis to determine odds ratios of having a “hidden body fat” profile based on dietary and physical activity patterns; and miRNA expression profiles; and Pearson correlations to determine correlation coefficients between dietary and physical activity patterns and gene expression profiles.
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Phase Not Applicable
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Anticipated date of first participant enrolment 1/07/2013
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Date of first participant enrolment
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Anticipated date last participant recruited/enrolled 29/06/2014
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Actual date last participant recruited/enrolled
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Target sample size 675
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Recruitment status Not yet recruiting
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Recruitment in Australia

Recruitment state(s)
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Recruitment outside Australia

Country: New Zealand 5158 0
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State/Province: Auckland 5158 0
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Funding Source: Charities/Societies/Foundations 287488 0
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Name: NUTRICIA RESEARCH FOUNDATION Founded for the advancement of research in human nutrition 287488 0
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Address: Nutricia Research Foundation
P.O. Box 7005
6700 CA WAGENINGEN
The Netherlands

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Country: Netherlands 287488 0
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Primary Sponsor University
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Name: Massey University
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Address: Massey University
Eastbourne Rd
Oteha Rohe Campus
Albany
Auckland
0632
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Country: New Zealand
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Secondary Sponsor: None 286265 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Massey University Human Ethics Committee: Southern A 289464 0
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Address: Massey University Human Ethics Committee: Southern A
Massey University
Priovate Bag 11222
Palmerston North
4442


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Country: New Zealand 289464 0
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Approval Date: 30/05/2013 289464 0
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Submitted Date: 08/03/2013 289464 0
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HREC: 13/13 289464 0
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Brief summary Looks can be deceiving. Individuals that appear slender and healthy may actually have significant and unhealthy fat stores. Previous pilot data identified women with normal body mass index, but an excessive amount of body fat. They appeared lean and healthy, but could have increased risk of inflammatory and metabolic disorders. Genetic make-up may predispose women to this phenomenon; however environmental changes, like diet and activity may change the consequences.
A significant proportion of young women (~20%), usually classified as having normal BMI (43.0% of the NZ population), may in actual fact have a hidden fat profile with related higher metabolic risk. Since BMI is often used as an indicator for health body size, these women will remain unidentified and will be excluded from early intervention or prevention practices in the public health system. Adolescent BMI values peak at 16 years, are higher in girls, and continue to rise until the age of 34 to 44 years. Therefore this research will target this vulnerable group of post-menarche, premenopausal women, potentially practicing risky eating or lifestyle behaviours that contribute to excessive fat deposition affecting metabolic profiles that may benefit from preventive action.
We hypothesise that the “hidden fat profile” is associated with increased metabolic disease risk in New Zealand (NZ) European, Maori, and Pasifika women aged 16 to 45 years. We also believe that dietary and physical activity patterns are predictors of body composition profiles by modulating gene (microRNA) expression associated with energy expenditure/storage. Variations in taste perception may further be associated with metabolic phenotypes and/or food preference. This has never been investigated in the multi-ethnic New Zealand population. In addition, we are intrigued to find out whether our nature (genes) is influenced by our nurture (dietary intake and physical activity) when accumulating body fat, and if it differs between ethnicities, particularly in this new emerging at risk group of women carrying hidden fat. These findings may guide evidence-based practice to improve health outcomes, reducing health care costs.
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Trial website
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Trial related presentations / publications
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Public Notes
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Principal Investigator
Title: Dr
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Name: Rozanne Kruger
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Address: Institute of Food, Nutrition and Human Health Private Bag 102 904 Massey University Auckland 0745
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Country: New Zealand
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Tel: +6494140800 x 41209
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Fax: +6494439640
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Email: r.kruger@massey.ac.nz
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Contact person for public queries
Title: Ms
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Name: Carmel Truhubovich
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Address: Institute of Food, Nutrition and Human Health Private Bag 102 904 Massey University Auckland 0745
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Country: New Zealand
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Tel: +64 09 4140800 x 41200
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Email: c.truhubo@massey.ac.nz
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Contact person for scientific queries
Title: Dr
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Name: Rozanne Kruger
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Address: Institute of Food, Nutrition and Human Health Private Bag 102 904 Massey University Auckland 0745
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Country: New Zealand
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Tel: +6494140800 x 41209
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Fax: +6494439640
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Email: r.kruger@massey.ac.nz
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Contact person responsible for updating information
Title: Dr
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Name: Rozanne Kruger
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Address: Institute of Food, Nutrition and Human Health Private Bag 102 904 Massey University Auckland 0745
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Country: New Zealand
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Tel: +6494140800 x 41209
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Fax: +6494439640
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Email: r.kruger@massey.ac.nz
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Addition Cancer fields
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