Exogenous Ketone Supplementation and Exercise Performance

NCT03895892 | Unknown DMC

• 1 other identifier: 113474
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 20 km time trial

  participants will ride for 20 km on a stationary bike and time to complete distance will be measured.

  40 minutes

• Wingate test

  participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.

  30 seconds

Secondary Outcomes (3)

• Blood Ketone

  1 hour

• Blood Lactate

  1 hour

• Rates of perceived exertion (RPE)

  1 hour

Study Arms (3)

Water Placebo

PLACEBO COMPARATOR

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

Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Water Placebo

Experimental 1

EXPERIMENTAL

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

Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Ketone

Experimental 2

EXPERIMENTAL

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

Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary Supplement: Ketone/Caffeine

Interventions

20 km time trial BEHAVIORAL

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

Experimental 1; Experimental 2; Water Placebo

Wingate test BEHAVIORAL

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

Experimental 1; Experimental 2; Water Placebo

Ketone/Caffeine DIETARY_SUPPLEMENT

Dietary supplement containing ketone salts and caffeine

Experimental 2

Ketone DIETARY_SUPPLEMENT

Dietary supplement containing only ketone salts

Experimental 1

Water Placebo DIETARY_SUPPLEMENT

Dietary supplement containing only water

Water Placebo

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Western University, Canada: lead

Study Sites (1)

Exercise Nutrition Laboratory (Western University)

London, Ontario, N6A 3K7, Canada

RECRUITING

MeSH Terms

Conditions

Ketosis

Interventions

Ketones; Caffeine

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals; Xanthines; Alkaloids; Heterocyclic Compounds; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Peter Lemon, PhD

  Western University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Lemon, PhD

CONTACT

519 6612111; plemon@uwo.ca

Manuel D Quinones, MSc

CONTACT

5196612111

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will be blinded as an individual not involved in the project will assemble and distribute the treatment (drinks) according to a coding system that is kept confidential until the study is completed. Participants will complete the protocol three times and the treatment order will be systematically rotated to avoid any order effect. taste and texture of treatments will be matched and will be distribute in opaque bottles to keep participant blinded
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This will be a double blind repeated measures cross over 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. Design of the study is composed of two performance tests 30 minutes following supplementation. All participants will arrive in a fed state to the laboratory. the corresponding treatment will be provided and 30 minutes later, they will perform a 20 km time trial. 10 minutes after the time trial, participants will perform a 30 second all-out Wingate test.

Study Record Dates

• First Submitted: February 13, 2019
• First Posted: March 29, 2019
• Study Start: May 15, 2019
• Primary Completion: December 1, 2019
• Study Completion: December 1, 2019
• Last Updated: October 2, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)