Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
Scientific title
The Use of Nutrigenomics in Sports Nutrition
Secondary ID [1] 0 0
5000928
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sport Nutrition 0 0
Nutrigenomics 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Changes in dietary intake from baseline
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Changes in body composition from baseline
Timepoint [1] 0 0
8 weeks

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- N/A

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
4/06/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Other
Name
University of Auckland, New Zealand
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04914156
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04914156