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/study/NCT02031783




Registration number
NCT02031783
Ethics application status
Date submitted
26/11/2013
Date registered
9/01/2014
Date last updated
9/07/2014

Titles & IDs
Public title
Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance
Scientific title
Secondary ID [1] 0 0
13.09.PER
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy 0 0
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Experimental: mixture of glucose and fructose - mixture of glucose and fructose

Active comparator: Glucose - Single glucose
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
TIME to finish a long distance triathlon
Timepoint [1] 0 0
Total time recorded at the end of the race 1 and race 2

Eligibility
Key inclusion criteria
* Males aged 18 to 60 years
* A history of competitive triathlon performance (= 2 years)
* Participation in at least four competitive triathlon events within the past 2 years
* Be in regular training for triathlon events
* A personal best time for a standard ½ Ironman race (1.9 km swim, 90 km cycle, 21.1 km run) in the last year of either:

* = 6 h 00 min, for men aged 18-40 years
* or =6 h 05 min for men aged 40-50 years
* or =6 h 20 min for men aged 50-60 years
* Alternatively, if not competed in ½ Ironman in the last year, at least one standard distance triathlon (1.5 km swim, 40 km cycle, 10 km run) within the last 12 months:

* =2 h 13 min, for men aged 18-40 years
* or =2 h 18 min for men aged 40-50 years
* or =2 h 23 min for men aged 50-60 years
* Available to compete in the ½ Ironman events and complete all study requirements
* Experienced in using carbohydrate supplementation, as gels, bars, and drinks in training/racing, specifically at rates =60-90g/h)
* Experience of specific formulations may include both or only multiple and single transportable carbohydrates, thus a full assessment would be made prior to recruitment to ensure balance during randomization and account for any association with the primary outcome
* Obtained his (or his legal representative's) informed consent.
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
* Failure to meet health requirements defined in the Health Questionnaire
* Prior known fructose intolerance
* Wheat intolerance or other precluding food or packaging-related allergies
* An existing injury affecting ability to race to best ability
* A chronic injury that may affect ability to complete the races
* Unable to carry out performance assessments and questionnaires correctly
* Unable to tolerate the treatment during the familiarization sessions
* Taking medications thought to interfere with the study outcomes
* Currently participating or having participated in another clinical study during the last four weeks prior to the beginning of this study

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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
NA
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/01/2014
Sample size
Target
Accrual to date
Final
74
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Wellington

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Société des Produits Nestlé (SPN)
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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

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/NCT02031783