Sport NutritionNCT04914156
The Use of Nutrigenomics in Sports Nutrition
A study testing Genetic based dietary advice and Personalised population based dietary advice in people with Sport Nutrition and Nutrigenomics, run by University of Auckland, New Zealand at 1 site in New Zealand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Sport Nutrition, Nutrigenomics
- What is being tested?
- Genetic based dietary advice and Personalised population based dietary advice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteNew Zealand
- Study dates
- 4 Jun 2021to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18 years of age or older
- Competes in representative sports team
- Has access to the internet and smart phone device
- Able to speak English
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Sport Nutrition, Nutrigenomics
- Being tested
- Genetic based dietary advice, Personalised population based dietary advice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic based dietary adviceOther
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.
Personalised population based dietary adviceOther
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
| Study group | Role | What they receive |
|---|---|---|
| Personalised, genetic-based advice for sport performance | Experimental | This group will receive personalised nutrition advice for sports performance based on their genetic test results and tailored to their current dietary intake. Receives: Other: Genetic based dietary advice |
| Personalised nutrition advice for sport performance based on population-based evidence | Active comparator | 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 Receives: Other: Personalised population based dietary advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dietary intake from baseline
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.
Measured: 8 weeks
Secondary outcomes (1)
Changes in body composition from baseline
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2021
- Study start4 Jun 2021
- Primary completionSep 2022 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sport NutritionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Auckland, New Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Andrea Braakhuis, University of Auckland, New Zealand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04914156
- Sponsor's protocol ID
- 5000928
- Status last verified
- Sep 2021
- First submitted
- 30 May 2021
- Last updated
- 29 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Nutrigenomics in Sports Nutrition
- ClinicalTrials.gov ID
- NCT04914156
- Acronym / sponsor ID
- 5000928
- Conditions
- Sport Nutrition, Nutrigenomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of Auckland, New ZealandUniversity, hospital or other
- Study start
- 4 Jun 2021 (actual)
- Primary completion
- Sep 2022 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 4 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalised, genetic-based advice for sport performance | Experimental | Other: Genetic based dietary adviceThis group will receive personalised nutrition advice for sports performance based on their genetic test results and tailored to their current dietary intake. |
| Personalised nutrition advice for sport performance based on population-based evidence | Active comparator | Other: Personalised population based dietary adviceThis 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 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 18 years of age or older
- Competes in representative sports team
- Has access to the internet and smart phone device
- Able to speak English
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genetic based dietary adviceGenetic 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 | Personalised, genetic-based advice for sport performance |
| Personalised population based dietary adviceCurrent 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 | Other | Personalised nutrition advice for sport performance based on population-based evidence |
Primary outcome
Changes in dietary intake from baseline
Time frame: 8 weeks
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.
1 secondary outcome
Changes in body composition from baseline
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Genetic based dietary advice and Personalised population based dietary advice in people with Sport Nutrition and Nutrigenomics, run by University of Auckland, New Zealand at 1 site in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in dietary intake from baseline (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2021.