NCT01527266

Brief Summary

Several studies have reported that carbohydrate (CHO) ingestion can improve performance during exercise of short duration (less than 60 min). However, there is no apparent metabolic explanation for this observation because endogenous CHO stores should not be a limiting factor during short duration exercise. Nonetheless, several groups have attempted to investigate CHO administration during short duration exercise with varying results. When CHO was administered intravenously, no performance effect was observed despite greater plasma glucose availability (5). Therefore, it was suggested that during exercise of short duration, exogenous CHO ingestion may exert its ergogenic effect by action through the central nervous system, possibly mediated by glucose receptors in the mouth. The latter has been investigated using a CHO-mouth rinse, whereby the CHO solution is spat out to remove any influence of the gut on exogenous CHO oxidation or performance. Using this rinse, studies have demonstrated results both for (5, 16), and against (1, 19) any improvement in short duration exercise performance when compared with a placebo. The discrepancy in the findings may be due to testing subjects in the fed (1) or fasted-state (5), when liver glycogen stores may be compromised. However, no study has tested subjects in both the fasted and fed-state using a CHO-mouth rinse. It remains to be determined whether CHO-mouth rinse is only effective at improving short duration exercise performance when subjects are in the fasted, compared with the fed-state. The investigators will test the hypothesis that CHO-mouth rinse improves performance in the fasted-state only compared with a placebo-rinse.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 12, 2012

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 6, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

October 17, 2012

Status Verified

October 1, 2012

Enrollment Period

10 months

First QC Date

January 12, 2012

Last Update Submit

October 16, 2012

Conditions

Keywords

carbohydrateperformancecycling

Outcome Measures

Primary Outcomes (4)

  • Time to complete a set amount of work (time-trial performance)

    Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.

    laboratory visit 2

  • Time to complete a set amount of work (time trial performance)

    Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.

    laboratory visit 3

  • Time to complete a set amount of work (time-trial performance)

    Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.

    laboratory visit 4

  • Time to complete a set amount of work (time-trial performance)

    Time to complete the set amount of work measured in minutes. To determine if one intervention allows the subject to complete the given amount of work in a faster time period than the placebo.

    laboratory visit 5

Study Arms (4)

carbohydrate mouth rinse fasted

EXPERIMENTAL

sucrose mouth rinse in the fasted state

Dietary Supplement: Carbohydrate drink

carbohydrate mouth rinse fed

EXPERIMENTAL

sucrose mouth rinse fed state

Dietary Supplement: Carbohydrate drink

Placebo mouth rinse fed

PLACEBO COMPARATOR

placebo (non-caloric sweetened drink) in the fed state

Dietary Supplement: Placebo mouth rinse

Placebo mouth rinse fasted

PLACEBO COMPARATOR

placebo (non-caloric sweetened drink) in the fasted condition

Dietary Supplement: Placebo mouth rinse

Interventions

Carbohydrate drinkDIETARY_SUPPLEMENT

sucrose beverage

carbohydrate mouth rinse fastedcarbohydrate mouth rinse fed
Placebo mouth rinseDIETARY_SUPPLEMENT

placebo; non-caloric sweetened beverage for use as a mouth rinse

Placebo mouth rinse fastedPlacebo mouth rinse fed

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male
  • years of age
  • Endurance cycling trained (≥ 3 sessions of endurance exercise per week)
  • VO2 max ≥ 50 ml/kg/min
  • Training history of more than one year of ≥ 3 sessions of endurance cycling exercise per week
  • BMI \< 25 kg/m2

You may not qualify if:

  • Use of medication
  • Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maastricht University

Maastricht, Netherlands

RECRUITING

Study Officials

  • Luc van Loon, Ph.D.

    Maastricht University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2012

First Posted

February 6, 2012

Study Start

February 1, 2012

Primary Completion

December 1, 2012

Study Completion

January 1, 2013

Last Updated

October 17, 2012

Record last verified: 2012-10

Locations