Exogenous Ketone Supplementation and Exercise Performance

Ketosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03895892
• Other study ID #: 113474
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2019
• Est. completion date: December 2019

Study information

• Verified date: September 2019
• Source: Western University, Canada
• Contact: Peter Lemon, PhD
• Phone: 519 6612111
• Email: plemon[@]uwo.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 2019
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Ketonemia
• Ketosis

Intervention

Behavioral:
• 20 km time trial
20 km time trial cycling test will be conducted to measure the effect of different drinks on time
• 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
• Ketone
Dietary supplement containing only ketone salts
• Water Placebo
Dietary supplement containing only water

Locations

Country	Name	City	State
Canada	Exercise Nutrition Laboratory (Western University)	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Western University, Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	20 km time trial	participants will ride for 20 km on a stationary bike and time to complete distance will be measured.	40 minutes
Primary	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	Blood Ketone	blood ketones will be measured using ketone meter	1 hour
Secondary	Blood Lactate	blood lactate will be measured using lactate meter	1 hour
Secondary	Rates of perceived exertion (RPE)	RPE will be measured using Borg's scale (1= low - 10= high).	1 hour