NCT02825823

Brief Summary

The ketone body beta-hydroxybutyrate is produced during prolonged fasting or exercise and can be used as an alternative fuel source. Exogenous beta-hydroxybutyrate, in the form of a ketone salt, is proposed to have ergogenic potential for high-intensity exercise performance but this has not been adequately studied. The purpose of this study is to determine whether supplementing with an acute dose of ketone salts can alter fuel use during exercise and improve exercise performance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

July 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 4, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

October 13, 2017

Status Verified

October 1, 2017

Enrollment Period

11 months

First QC Date

July 4, 2016

Last Update Submit

October 12, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Respiratory Exchange Ratio (RER) during cycling exercise

    The RER during 18 minutes of steady-state exercise

    0-18 minutes

Secondary Outcomes (1)

  • 10 km Cycling Time Trial Performance

    Following 18 minutes of steady-state exercise

Study Arms (2)

Ketone Salts

EXPERIMENTAL

Acute dose of beta-hydroxybutyrate potassium/sodium salt (0.2g beta-hydroxybutyrate/kg, 0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose)

Dietary Supplement: Ketone Salt

Placebo

PLACEBO COMPARATOR

Acute dose of taste-matched placebo (0.01g Potassium/kg, 0.01g Sodium/kg with 1 g Steviol Glycoside and 30 ml of lemon juice per dose)

Dietary Supplement: Placebo

Interventions

Ketone SaltDIETARY_SUPPLEMENT
Ketone Salts
PlaceboDIETARY_SUPPLEMENT
Placebo

Eligibility Criteria

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

You may qualify if:

  • Males aged 18-40
  • Ability to understand and communicate in English to answer questionnaires and interact with the research assistant
  • Physically active (defined by engaging in moderate-to-vigorous exercise at least 3 times per week, determined via validated questionnaire)

You may not qualify if:

  • Diagnosed with diabetes or any other medical conditions that could affect metabolism.
  • Diagnosed with heart disease or taking anti-hypertensive medications.
  • Competitive endurance athlete (self-identified as engaged in specific endurance training in triathlon, cycling, or distance running and competing in races or competition)
  • Recent (last 3 months) or current consumption of a low-carbohydrate ketogenic diet
  • Current consumption of ketone supplements
  • Any other contraindication to vigorous exercise (identified via physical activity readiness questionnaire \[PAR-Q\])

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of British Columbia, Okanagan.

Kelowna, British Columbia, V1V 1V7, Canada

Location

MeSH Terms

Conditions

Motor ActivityKetosis

Condition Hierarchy (Ancestors)

BehaviorAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 4, 2016

First Posted

July 7, 2016

Study Start

July 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

October 13, 2017

Record last verified: 2017-10

Locations