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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT04914156
Registration number
NCT04914156
Ethics application status
Date submitted
30/05/2021
Date registered
4/06/2021
Date last updated
29/09/2021
Titles & IDs
Public title
The Use of Nutrigenomics in Sports Nutrition
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Scientific title
The Use of Nutrigenomics in Sports Nutrition
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Secondary ID [1]
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5000928
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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:
Sport Nutrition
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Nutrigenomics
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Condition category
Condition code
Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Other interventions - Genetic based dietary advice
Other interventions - Personalised population based dietary advice
Experimental: Personalised, genetic-based advice for sport performance - This group will receive personalised nutrition advice for sports performance based on their genetic test results and tailored to their current dietary intake.
Active comparator: Personalised nutrition advice for sport performance based on population-based evidence - This group will receive personalised nutrition advice on key nutrients relating to sports performance based on current best practice, population-based sport nutrition guidelines. These will be tailored to their current dietary intake
Other interventions: Genetic based dietary advice
Genetic test results for 70 genes relating to nutrition and physical activity will be used in conjunction with participants current dietary intake to create nutrition advice tailored to each individual.
Other interventions: Personalised population based dietary advice
Current dietary intake will be compared with current best practice population-based sports nutrition dietary advice to create tailored nutrition advice for each of the participants
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Changes in dietary intake from baseline
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Assessment method [1]
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We will assess dietary intake for energy intake, carbohydrates, protein, fat, sodium, caffeine, glycemic index, iron, Vitamin A, Vitamin B12, Vitamin C, Vitamin D, Vitamin E, Folate and Calcium using a 3 day food record conducted at baseline using Easy Diet Diary phone application. A second 3 day food record will be conducted post intervention period to examine any changes in dietary habits.
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Timepoint [1]
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8 weeks
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Secondary outcome [1]
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Changes in body composition from baseline
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Assessment method [1]
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At baseline, participants will indicate body composition goals and baseline body composition measurements will be taken using International Society for Advancement of Kinanthropometry accredited guidelines. Repeated body composition measurements will be taken post intervention to examine in any changes in body composition.
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Timepoint [1]
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8 weeks
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Eligibility
Key inclusion criteria
* 18 years of age or older
* Competes in representative sports team
* Has access to the internet and smart phone device
* Able to speak English
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* N/A
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Study design
Purpose of the study
Other
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
NA
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
4/06/2021
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/09/2024
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Actual
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Sample size
Target
30
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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New Zealand
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State/province [1]
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Auckland
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Funding & Sponsors
Primary sponsor type
Other
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Name
University of Auckland, New Zealand
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Address
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Country
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Ethics approval
Ethics application status
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Summary
Brief summary
The study's aim is to determine if nutrigenomics-based dietary advice is a greater motivator for dietary change amongst an athlete population. Specifically, the investigators will be examining whether nutrigenomics-based personalized dietary advice results in greater changes in dietary intake and body composition amongst athletes compared to personalised population-based sports nutrition advice. It is hypothesized that the Nutrigenomics in Sports Nutrition group would engage in greater dietary changes and better adhere to the dietary advice compared to the standard advice group.
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Trial website
https://clinicaltrials.gov/study/NCT04914156
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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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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT04914156
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