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Exogenous Ketone Supplementation and Exercise Performance

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ClinicalTrials.gov Identifier: NCT03895892
Recruitment Status : Recruiting
First Posted : March 29, 2019
Last Update Posted : October 2, 2019
Sponsor:
Information provided by (Responsible Party):
Peter Lemon, Western University, Canada

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.

Condition or disease Intervention/treatment Phase
Ketonemia Ketosis Behavioral: 20 km time trial Behavioral: Wingate test Dietary Supplement: Ketone/Caffeine Dietary Supplement: Ketone Dietary Supplement: Water Placebo Not Applicable

Detailed Description:
Some researchers support that a state of ketosis, reached through the use of ketogenic diet, has the potential to improve athletic. To attain such state, individuals must restrict carbohydrate intake to a maximum of 50g/ day or 10% while keeping protein intake moderate. One of the biggest challenges to achieve and maintain ketosis is complying with the diet due to its restrictive nature. Consequently, manufacturers have developed supplements that can induce a state of ketosis acutely (~1 hour). Unfortunately, there is very little evidence supporting the use of these supplements to enhance athletic performance. Hyperketonemia (blood ketone concentration > 0.2 Mm) seems to elevate the rate of utilization of ketone bodies. These changes in substrate utilization may allow athletes to preserve, something that would be advantageous for exercise performance. Ketone salts have been shown to elevate the concentration of ketones in blood and as such they may allow the body benefit from the apparent sparing of carbohydrates. Manufacturers now provide ketones salts combined with other ingredients such as caffeine. However it is unknown whether or not the addition of these ingredients has any positive or negative effect on athletic performance. Caffeine alone has been shown to improve athletic performance in several studies. Therefore, the purpose of this study is to compare the effectiveness of a caffeine free ketone salt supplement vs a caffeinated ketone salt supplement and their effects on a 20km time trial and a 30 second all-out Wingate test.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 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.
Masking: Double (Participant, Investigator)
Masking Description: 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
Primary Purpose: Other
Official Title: The Effect of Exogenous Ketone Supplementation on 20 km Time Trial and Wingate Performance in Recreationally Active Individuals
Actual Study Start Date : May 15, 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Arm Intervention/treatment
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
Behavioral: 20 km time trial
20 km time trial cycling test will be conducted to measure the effect of different drinks on time

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

Dietary Supplement: Water Placebo
Dietary supplement containing only water

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

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

Dietary Supplement: Ketone
Dietary supplement containing only ketone salts

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

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

Dietary Supplement: Ketone/Caffeine
Dietary supplement containing ketone salts and caffeine




Primary Outcome Measures :
  1. 20 km time trial [ Time Frame: 40 minutes ]
    participants will ride for 20 km on a stationary bike and time to complete distance will be measured.

  2. Wingate test [ Time Frame: 30 seconds ]
    participants will perform a ver short all-out effort on a stationary bike. peak power output and fatigue index will be measured.


Secondary Outcome Measures :
  1. Blood Ketone [ Time Frame: 1 hour ]
    blood ketones will be measured using ketone meter

  2. Blood Lactate [ Time Frame: 1 hour ]
    blood lactate will be measured using lactate meter

  3. Rates of perceived exertion (RPE) [ Time Frame: 1 hour ]
    RPE will be measured using Borg's scale (1= low - 10= high).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03895892


Contacts
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Contact: Peter Lemon, PhD 519 6612111 ext 88139 plemon@uwo.ca
Contact: Manuel D Quinones, MSc 5196612111 ext 88164

Locations
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Canada, Ontario
Exercise Nutrition Laboratory (Western University) Recruiting
London, Ontario, Canada, N6A 3K7
Contact: Peter Lemon, PhD    519 6612111 ext 88139    plemon@uwo.ca   
Sponsors and Collaborators
Western University, Canada
Investigators
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Principal Investigator: Peter Lemon, PhD Western University

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Responsible Party: Peter Lemon, Principal Investigator, Western University, Canada
ClinicalTrials.gov Identifier: NCT03895892    
Other Study ID Numbers: 113474
First Posted: March 29, 2019    Key Record Dates
Last Update Posted: October 2, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Ketosis
Acidosis
Acid-Base Imbalance
Metabolic Diseases
Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents