Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-01-02 @ 12:22 AM
Study NCT ID:
NCT04914156
Status:
UNKNOWN
Last Update Posted:
2021-09-29
First Post:
2021-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Nutrigenomics in Sports Nutrition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-09-27', 'studyFirstSubmitDate': '2021-05-30', 'studyFirstSubmitQcDate': '2021-05-30', 'lastUpdatePostDateStruct': {'date': '2021-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in dietary intake from baseline', 'timeFrame': '8 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Changes in body composition from baseline', 'timeFrame': '8 weeks', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sport Nutrition', 'Nutrigenomics']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* Competes in representative sports team\n* Has access to the internet and smart phone device\n* Able to speak English\n\nExclusion Criteria:\n\n* N/A'}, 'identificationModule': {'nctId': 'NCT04914156', 'briefTitle': 'The Use of Nutrigenomics in Sports Nutrition', 'organization': {'class': 'OTHER', 'fullName': 'University of Auckland, New Zealand'}, 'officialTitle': 'The Use of Nutrigenomics in Sports Nutrition', 'orgStudyIdInfo': {'id': '5000928'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalised, genetic-based advice for sport performance', 'description': 'This group will receive personalised nutrition advice for sports performance based on their genetic test results and tailored to their current dietary intake.', 'interventionNames': ['Other: Genetic based dietary advice']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Personalised nutrition advice for sport performance based on population-based evidence', 'description': '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', 'interventionNames': ['Other: Personalised population based dietary advice']}], 'interventions': [{'name': 'Genetic based dietary advice', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Personalised, genetic-based advice for sport performance']}, {'name': 'Personalised population based dietary advice', 'type': 'OTHER', 'description': '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', 'armGroupLabels': ['Personalised nutrition advice for sport performance based on population-based evidence']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Auckland', 'country': 'New Zealand', 'facility': 'University of Auckland', 'geoPoint': {'lat': -36.84853, 'lon': 174.76349}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Auckland, New Zealand', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Academic Director for the Master of Health Sciences in Nutrition & Dietetics', 'investigatorFullName': 'Dr Andrea Braakhuis', 'investigatorAffiliation': 'University of Auckland, New Zealand'}}}}