NCT03954665

Brief Summary

The purpose of this study is to observe the effects of exogenous ketone supplements during shorter bouts of exercise testing on twenty collegiate endurance trained athletes (18-25 years of age).

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

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

May 6, 2019

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 17, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
Last Updated

July 23, 2019

Status Verified

April 1, 2019

Enrollment Period

4 months

First QC Date

May 6, 2019

Last Update Submit

July 22, 2019

Conditions

KetosisExercise PerformanceKetoses, Metabolic

Keywords

KetonesSupplementationExercise Performance

Outcome Measures

Primary Outcomes (2)

  • 10 km Time trial

    10km time trial where participants will be measured on time to completion

    15-20 Minutes

  • 30s Wingate

    30s Wingate all out test where participants will be measured on their peak power output

    30 seconds

Secondary Outcomes (3)

  • Blood Ketones

    1-2 hours

  • Blood Glucose

    1-2 hours

  • Blood Lactate

    1-2 hours

Study Arms (2)

Baseline Testing

ACTIVE COMPARATOR

Baseline testing for a 10km cycle time trial and a 30s Wingate cycle test.

Behavioral: Baseline 10 km time trialBehavioral: Baseline 30s Wingate

Dietary Supplement: Exogenous Ketone Salt

EXPERIMENTAL

Ketone salt supplementation (0.6-0.8g•kg-1•d-1) 7-days. Participants will perform two exercise performance tests (a 10km cycle time trial and a 30s Wingate cycle test on separate days) after supplementation.

Behavioral: 10 km time trialBehavioral: 30s WingateDietary Supplement: Ketone

Interventions

10 km time trialBEHAVIORAL

10 km Cycling time trial test will be conducted to examine the effects of the Exogenous Ketone Salts on time

Dietary Supplement: Exogenous Ketone Salt
30s WingateBEHAVIORAL

30s all-out test to measure peak power output

Dietary Supplement: Exogenous Ketone Salt
KetoneDIETARY_SUPPLEMENT

Supplement containing exogenous ketone salts

Dietary Supplement: Exogenous Ketone Salt
Baseline 10 km time trialBEHAVIORAL

A baseline 10 km Cycling time trial test will be conducted

Baseline Testing
Baseline 30s WingateBEHAVIORAL

A baseline 30s all-out test to measure peak power output

Baseline Testing

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female Collegiate Endurance Trained Athletes
  • ≥2 year training experience; ≥7 h/week
  • Ages 18-25

You may not qualify if:

  • Smoker
  • Injury that will affect exercise performance
  • Sedentary Behaviour
  • Currently following a High Fat diet/Ketogenic diet
  • Taking Beta Blockers or Hypertension Medication
  • Has Respiratory, Cardiovascular and/or Neuromuscular disease that is not cleared for exercise by a physician.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Nutrition Laboratory, Western University

London, Ontario, N6A3K7, Canada

Location

Related Publications (3)

  • Waldman HS, Basham SA, Price FG, Smith JW, Chander H, Knight AC, Krings BM, McAllister MJ. Exogenous ketone salts do not improve cognitive responses after a high-intensity exercise protocol in healthy college-aged males. Appl Physiol Nutr Metab. 2018 Jul;43(7):711-717. doi: 10.1139/apnm-2017-0724. Epub 2018 Feb 16.

    PMID: 29451991BACKGROUND

  • O'Malley T, Myette-Cote E, Durrer C, Little JP. Nutritional ketone salts increase fat oxidation but impair high-intensity exercise performance in healthy adult males. Appl Physiol Nutr Metab. 2017 Oct;42(10):1031-1035. doi: 10.1139/apnm-2016-0641. Epub 2017 Jul 27.

    PMID: 28750585BACKGROUND

  • Volek JS, Noakes T, Phinney SD. Rethinking fat as a fuel for endurance exercise. Eur J Sport Sci. 2015;15(1):13-20. doi: 10.1080/17461391.2014.959564. Epub 2014 Oct 2.

    PMID: 25275931RESULT

MeSH Terms

Conditions

Ketosis

Interventions

KetonesBaseLine dental cement

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Organic Chemicals

Study Officials

  • Peter WR Lemon, PhD

    Western University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sydney EL Isbell, BSc

CONTACT

5196612111sisbell@uwo.ca

Manuel D Quinones, MSc

CONTACT

5196612111

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2019

First Posted

May 17, 2019

Study Start

September 1, 2019

Primary Completion

January 1, 2020

Study Completion

March 1, 2020

Last Updated

July 23, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)