Recruiting

Ketone Supplementation

Sponsor:

Western University, Canada

Code:

NCT03895892

Conditions

Ketonemia

Ketosis

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Interventions

20 km time trial

Wingate test

Ketone/Caffeine

Ketone

Water Placebo

Study Details

Brief summary:

20 healthy recreationally active men and woman aged 18-35 will participate in the study. There will be three treatments involved: Caffeinated ketone supplements, non-caffeinated ketone supplement and water-placebo. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. The three main trials will be separated by at least 1 week. After providing the corresponding treatment, participants will be given 30 minutes and after, they will perform a standardized 10-minute warm-up, followed by the 20 km time trial and a 30-second all-out Wingate test.

Conditions

Ketonemia

Ketosis

Study ID

NCT03895892

Start date

May 15, 2019

Status verified date

Sep, 2019

Completion date

Dec, 2019

Anticipated

Primary completion date

Dec, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 35

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Healthy male and female recreationally active individuals
  • aged 15-35 years
  • non regular caffeine users.

Exclusion Criteria:

  • Smoker
  • Taking part in other research
  • Sedentary
  • For women, if they are pregnant or become pregnant during the study
  • Injury limiting exercise ability.
  • Have symptoms or take medication for respiratory disease
  • Have symptoms or take medication for cardiovascular 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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Other

Interventions and Outcome Measures

Arms

placebo comparator: Water Placebo

Placebo flavored drink similar to treatments but with no energy will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

experimental: Experimental 1

Ketone salts supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

experimental: Experimental 2

Ketone salts/caffeine supplement mixed in water will be ingested before completing a 20km Time trial and a 30 second all-out Wingate test

Interventions

20 km time trial

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

Wingate test

30 second all-out effort on a bike will be conducted to measure the effect of different drinks on peak power output

Ketone/Caffeine

Dietary supplement containing ketone salts and caffeine

Ketone

Dietary supplement containing only ketone salts

Water Placebo

Dietary supplement containing only water

Primary outcome measure

  • 20 km time trial [ Time Frame: 40 minutes ]
  • Wingate test [ Time Frame: 30 seconds ]

Central Contacts and Locations

Central contacts

Peter Lemon, PhD

519 6612111plemon@uwo.ca

Manuel D Quinones, MSc

5196612111

Locations

Exercise Nutrition Laboratory (Western University)

Recruiting

London, Ontario, Canada, N6A 3K7

Contacts

Peter Lemon, PhD

519 6612111plemon@uwo.ca

More Information

Sponsor

Western University, Canada

Last update posted

Oct 2, 2019

Last verified

Sep, 2019

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2019-10-02.