Glucose:Fructose Versus Glucose Carbohydrate Ingestion and Endurance Performance

Healthy Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02031783
• Other study ID #: 13.09.PER
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: July 8, 2014
• Start date: November 2013
• Est. completion date: January 2014

Study information

• Verified date: July 2014
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Ethics Committee
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• Mixture of glucose and fructose

• glucose

Locations

Country	Name	City	State
New Zealand	Massey University	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TIME to finish a long distance triathlon		Total time recorded at the end of the race 1 and race 2	No