Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000714785
Ethics application status
Approved
Date submitted
21/06/2013
Date registered
28/06/2013
Date last updated
28/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Hidden fat in young New Zealand women – what are the metabolic risk and predictive factors?
Scientific title
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.
Secondary ID [1] 282714 0
Nil known
Universal Trial Number (UTN)
Nil
Trial acronym
Women’s EXPLORE study –
“EXamining Predictors Linking Obesity Related Elements”
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 289430 0
Risk factors for metabolic syndrome, Type 2 Diabetes Mellitus, Cardiovascular Disease 289431 0
Condition category
Condition code
Diet and Nutrition 289761 289761 0 0
Obesity
Metabolic and Endocrine 289810 289810 0 0
Metabolic disorders
Cardiovascular 289811 289811 0 0
Coronary heart disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description 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.


Intervention code [1] 287376 0
Not applicable
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.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289845 0
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).
Timepoint [1] 289845 0
This study will be conducted as a cross-sectional comparative designed study.
Primary outcome [2] 289846 0
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.
Timepoint [2] 289846 0
This study will be conducted as a cross-sectional comparative designed study.
Primary outcome [3] 289847 0
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.
Timepoint [3] 289847 0
This study will be conducted as a cross-sectional comparative designed study.
Secondary outcome [1] 303372 0
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).
Timepoint [1] 303372 0
This study will be conducted as a cross-sectional comparative designed study.
Secondary outcome [2] 303373 0
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).
Timepoint [2] 303373 0
This study will be conducted as a cross-sectional comparative designed study.
Secondary outcome [3] 303374 0
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).
Timepoint [3] 303374 0
This study will be conducted as a cross-sectional comparative designed study.
Secondary outcome [4] 303375 0
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).
Timepoint [4] 303375 0
This study will be conducted as a cross-sectional comparative designed study.

Eligibility
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)).
Minimum age
16 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria include pregnancy, lactation, and presence of any illness.

Study design
Purpose
Screening
Duration
Cross-sectional
Selection
Defined population
Timing
Both
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.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
29/06/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
675
Accrual to date
Final
Recruitment outside Australia
Country [1] 5158 0
New Zealand
State/province [1] 5158 0
Auckland

Funding & Sponsors
Funding source category [1] 287488 0
Charities/Societies/Foundations
Name [1] 287488 0
NUTRICIA RESEARCH FOUNDATION
Founded for the advancement of research in human nutrition
Country [1] 287488 0
Netherlands
Primary sponsor type
University
Name
Massey University
Address
Massey University
Eastbourne Rd
Oteha Rohe Campus
Albany
Auckland
0632
Country
New Zealand
Secondary sponsor category [1] 286265 0
None
Name [1] 286265 0
Address [1] 286265 0
Country [1] 286265 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289464 0
Massey University Human Ethics Committee: Southern A
Ethics committee address [1] 289464 0
Ethics committee country [1] 289464 0
New Zealand
Date submitted for ethics approval [1] 289464 0
08/03/2013
Approval date [1] 289464 0
30/05/2013
Ethics approval number [1] 289464 0
13/13

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

Contacts
Principal investigator
Name 40918 0
Dr Rozanne Kruger
Address 40918 0
Institute of Food, Nutrition and Human Health
Private Bag 102 904
Massey University
Auckland
0745
Country 40918 0
New Zealand
Phone 40918 0
+6494140800 x 41209
Fax 40918 0
+6494439640
Email 40918 0
[email protected]
Contact person for public queries
Name 40919 0
Carmel Truhubovich
Address 40919 0
Institute of Food, Nutrition and Human Health
Private Bag 102 904
Massey University
Auckland
0745
Country 40919 0
New Zealand
Phone 40919 0
+64 09 4140800 x 41200
Fax 40919 0
+6494439640
Email 40919 0
[email protected]
Contact person for scientific queries
Name 40920 0
Rozanne Kruger
Address 40920 0
Institute of Food, Nutrition and Human Health
Private Bag 102 904
Massey University
Auckland
0745
Country 40920 0
New Zealand
Phone 40920 0
+6494140800 x 41209
Fax 40920 0
+6494439640
Email 40920 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
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