NCT03682861

Brief Summary

Fifteen endurance-trained male/female will be randomly assigned to do four exercise and nutrition trials involving ingestion of four different concentrations of sweet corn derived starch (food component) in water (0, 1, 1.5 and 2 g. kg-1. h-1). Each trial will be separated by at least one week. During these four experimental trials athletes will be subjected to a glycogen-lowering cycling exercise protocol followed by a 4-h post-exercise recovery period (2h feeding then 2 hours of rest). At the end of 4-h period they will do a 20 kilometre time trial test on a stationary bike in a laboratory condition to measure the effect of different glycogen repletion rates on exercise performance.

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 Sep 2018

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 21, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2018

Completed
5 days until next milestone

Study Start

First participant enrolled

September 30, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

December 5, 2018

Status Verified

December 1, 2018

Enrollment Period

1 year

First QC Date

September 21, 2018

Last Update Submit

December 3, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • 20 km time trial

    participants will ride for 20 km on a stationary bike and time to finish will be measured

    40 minutes

Secondary Outcomes (5)

  • VO2

    2 hours

  • Blood glucose

    2 hours

  • VCO2

    2 hours

  • Serum insulin

    2 hours

  • Blood lactate

    2 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo flavored drink similar to treatments but with no energy will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention

Behavioral: 20 km time trial performanceBehavioral: Glycogen lowering exercise

Carbohydrate drinks

EXPERIMENTAL

Sweet corn derived starch mixed in water at three different concentrations (6%, 12% and 18%) will be ingested post glycogen lowering exercise, followed by a 20 km time trial intervention

Behavioral: 20 km time trial performanceBehavioral: Glycogen lowering exercise

Interventions

20 km time trial cycling test will be conducted to measure the effect of different drinks on time

Carbohydrate drinksPlacebo

Glycogen will be lowered using a 10-min warm-up period at a workload of 50% max wattage power output (Wmax). Thereafter, participants will be instructed to cycle 2-min block periods at alternating workloads of 90% and 50% of Wmax, respectively. This will be continued until the participants are no longer able to complete the 2 min at 90% Wmax. That moment will be defined as the time at which the individual is unable to maintain cycling speed at 60 revolutions/min. At that moment the high-intensity block will be reduced to 80% Wmax. Again, athletes will cycle until they are unable to complete a 2-min block at 80% Wmax, after which the high-intensity block will be reduced to 70% Wmax. Finally, participants will be allowed to stop when pedalling speed could not be maintained at 70% Wmax.

Carbohydrate drinksPlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • are a healthy male or female endurance athlete of 18- 40 years of age
  • have ≥2 y endurance training experience; training for ˃1 h/day

You may not qualify if:

  • Have symptoms or take medication for respiratory disease
  • Have symptoms or take medication for cardiovascular disease
  • Have symptoms or take medication for metabolic disease
  • Have symptoms or take mediation for neuromuscular disease
  • Use heart rate or blood pressure medications
  • Use any medications with side effects of dizziness, lack of motor control, or slowed reaction time
  • Have any cardiovascular or neuromuscular limitations to exercise
  • Are pregnant or find out that you are pregnant during experiment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

RECRUITING

Related Publications (2)

  • Ivy JL. Glycogen resynthesis after exercise: effect of carbohydrate intake. Int J Sports Med. 1998 Jun;19 Suppl 2:S142-5. doi: 10.1055/s-2007-971981.

  • Upshaw AU, Wong TS, Bandegan A, Lemon PW. Cycling Time Trial Performance 4 Hours After Glycogen-Lowering Exercise Is Similarly Enhanced by Recovery Nondairy Chocolate Beverages Versus Chocolate Milk. Int J Sport Nutr Exerc Metab. 2016 Feb;26(1):65-70. doi: 10.1123/ijsnem.2015-0056. Epub 2015 Aug 27.

Study Officials

  • Peter Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD

CONTACT

Arash Bandegan, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Flavoured water placebo drink with no energy or carbohydrate drinks in opaque bottles to keep participant blinded
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: It is a repeated measure design where each participant will undergo all four treatment in a randomized fashion to prevent any order effect. Treatments (recovery drinks) include a placebo which will be similar in taste and flavour to other treatments and three carbohydrate containing drinks mixed in water at different concentrations. Design of the study is composed of three main stages: 1) glycogen lowering exercise, 2) glycogen replenishment and rest and 3) performance based, timed cycling exercise. All participants will arrive fasted to the laboratory, performing an exercise protocol that lowers their glycogen levels, followed by ingestion of different drinks (every 30 min) during 2 hours of a 4 hour rest and finally performing a 20 km stationary bike test for the time to finish to evaluate the effect of recovery drinks ingested.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 21, 2018

First Posted

September 25, 2018

Study Start

September 30, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

December 5, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will not share

Locations