HealthyNCT02031783
Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance
A study testing Mixture of glucose and fructose and glucose in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in New Zealand.
Trial summary
The primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion. Read more about this study
- Who is it for?
- Ages 18 to 60 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Mixture of glucose and fructose and glucose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteNew Zealand
- Study dates
- Nov 2013to Jan 2014
- 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 60 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
The primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion.
- Conditions
- Healthy
- Being tested
- Mixture of glucose and fructose, glucose
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mixture of glucose and fructoseDietary supplement
glucoseDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| mixture of glucose and fructose | Experimental | mixture of glucose and fructose Receives: Dietary Supplement: glucose |
| Glucose | Active comparator | Single glucose Receives: Dietary Supplement: Mixture of glucose and fructose |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIME to finish a long distance triathlon
Measured: Total time recorded at the end of the race 1 and race 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2014 (estimated)
- Study startNov 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02031783
- Sponsor's protocol ID
- 13.09.PER
- Status last verified
- Jul 2014
- First submitted
- 26 Nov 2013
- Last updated
- 9 Jul 2014
- Results posted
- No
Publications
Rowlands DS, Houltham SD. Multiple-Transportable Carbohydrate Effect on Long-Distance Triathlon Performance. Med Sci Sports Exerc. 2017 Aug;49(8):1734-1744. doi: 10.1249/MSS.0000000000001278.
PubMed 28350714
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance
- ClinicalTrials.gov ID
- NCT02031783
- Acronym / sponsor ID
- 13.09.PER
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 9 Jan 2014 (estimated)
- 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 primary objective is to show that multiple transportable carbohydrate ingestion is more effective in improving endurance performance compared to single transportable carbohydrate ingestion.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mixture of glucose and fructose | Experimental | Dietary Supplement: glucosemixture of glucose and fructose |
| Glucose | Active comparator | Dietary Supplement: Mixture of glucose and fructoseSingle glucose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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:
Key exclusion criteria (9 listed)
- 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
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 |
|---|---|---|
| Mixture of glucose and fructose | Dietary supplement | Glucose |
| glucose | Dietary supplement | mixture of glucose and fructose |
Primary outcome
TIME to finish a long distance triathlon
Time frame: Total time recorded at the end of the race 1 and race 2
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2014.
- Derived from this study: PubMed 28350714Rowlands DS, Houltham SD. Multiple-Transportable Carbohydrate Effect on Long-Distance Triathlon Performance. Med Sci Sports Exerc. 2017 Aug;49(8):1734-1744. doi: 10.1249/MSS.0000000000001278.
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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 Mixture of glucose and fructose and glucose in people with Healthy, run by Société des Produits Nestlé (SPN) 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 16 inclusion and 9 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: finished, as of the sponsor's last update on 9 Jul 2014. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
TIME to finish a long distance triathlon (time frame: Total time recorded at the end of the race 1 and race 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02031783, which also lists 1 linked publication.
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 9 Jul 2014.