- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02031783
Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance
July 8, 2014 updated by: Nestlé
The primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
74
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Wellington, New Zealand
- Massey University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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.
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: mixture of glucose and fructose
|
|
ACTIVE_COMPARATOR: Glucose
Single glucose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
TIME to finish a long distance triathlon
Time Frame: Total time recorded at the end of the race 1 and race 2
|
Total time recorded at the end of the race 1 and race 2
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2013
Primary Completion (ACTUAL)
January 1, 2014
Study Completion (ACTUAL)
January 1, 2014
Study Registration Dates
First Submitted
November 26, 2013
First Submitted That Met QC Criteria
January 8, 2014
First Posted (ESTIMATE)
January 9, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
July 9, 2014
Last Update Submitted That Met QC Criteria
July 8, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- 13.09.PER
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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