Exogenous Ketone Supplementation and Exercise Performance

The Effect of Exogenous Ketone Supplementation on 20 km Time Trial and Wingate Performance in Recreationally Active Individuals

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.

Study Overview

• Status: Unknown
• Conditions: Ketosis; Ketonemia
• Intervention / Treatment: Behavioral: 20 km time trial; Behavioral: Wingate test; Dietary supplement: Water Placebo; Dietary supplement: Ketone; Dietary supplement: Ketone/Caffeine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Manuel D Quinones, MSc; Phone Number: 88164 5196612111

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 3K7
      • Recruiting
      • Exercise Nutrition Laboratory (Western University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 33 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Ketone	blood ketones will be measured using ketone meter	1 hour
Blood Lactate	blood lactate will be measured using lactate meter	1 hour
Rates of perceived exertion (RPE)	RPE will be measured using Borg's scale (1= low - 10= high).	1 hour

Collaborators and Investigators

• Sponsor: Western University, Canada

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2019
• Primary Completion (Anticipated): December 1, 2019
• Study Completion (Anticipated): December 1, 2019

Study Registration Dates

• First Submitted: February 13, 2019
• First Submitted That Met QC Criteria: March 27, 2019
• First Posted (Actual): March 29, 2019

Study Record Updates

• Last Update Posted (Actual): October 2, 2019
• Last Update Submitted That Met QC Criteria: September 30, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Acid-Base Imbalance; Acidosis; Ketosis; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: 113474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• 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