Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists (KETA)
Primary Purpose
Ketoses, Metabolic, Ketosis
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ketone monoester
Control product consumption
Sponsored by
About this trial
This is an interventional other trial for Ketoses, Metabolic
Eligibility Criteria
Inclusion Criteria:
- Male professional cyclists.
- Start the study with previous rest.
Exclusion Criteria:
- Participant suffering from chronic illness.
- Suffering a long-term injury that prevents her from training in the month prior to the intervention.
- Inability to understand the informed consent.
- Having consumed ketone bodies chronically in the previous four weeks.
- To have undergone cholecystectomy.
Sites / Locations
- Catholic University of Murcia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ketone monoester
Control product
Arm Description
Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Outcomes
Primary Outcome Measures
Physical performance
Measured using a power roller. Variables such as maximum power and average power
Secondary Outcome Measures
Heart Rate
Measured by a chest strap
Microcapillary blood
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
Lactate
Lactate levels will be measured using the Lactate Pro
Ketone
Will be measured by the FreeStyle Optium
Blood glucose
Will be measured by the FreeStyle Optium
Blood glucose
It will be measured continuously by Supersapiens.
Heart rate variability
It will be measured for 5 minutes upon awakening.
Stomach test
It will be measured by means of a visual analog scale from 0 to 10 to determine the annoyance produced by the product (0: none and 10: maximum annoyance).
Fatigue
Rate of perceived exertion
Full Information
NCT ID
NCT05294939
First Posted
January 10, 2022
Last Updated
April 12, 2022
Sponsor
Universidad Católica San Antonio de Murcia
1. Study Identification
Unique Protocol Identification Number
NCT05294939
Brief Title
Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists
Acronym
KETA
Official Title
Randomized Clinical Trial to Analyze the Efficacy of Acute Intake of a Ketone Supplement on Performance in Professional Cross-country Road Cyclists
Study Type
Interventional
2. Study Status
Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
January 31, 2022 (Actual)
Primary Completion Date
February 5, 2022 (Actual)
Study Completion Date
March 28, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Católica San Antonio de Murcia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Randomized, controlled, double-blind, crossover clinical trial, depending on the product consumed, to analyze the efficacy on physical performance of a sports supplement consumed prior to and during competition or training.
Detailed Description
Subjects who meet the selection criteria will be randomly assigned to each of the study groups (investigational product or placebo, depending on the group to which they have been assigned). On the second day, participants will consume the product that subjects did not consume on the first day.
The product to be consumed will be ketone monoester. Participants will consume 800 mg/kg body weight, distributed in two intakes. The first one, half an hour before exercise and the same dose will be consumed one hour and a half after the first dose. The intakes will be accompanied by carbohydrates and bicarbonate.
The tests that the cyclists will perform are a time trial on a cycloergometer to measure performance, as well as a 30" sprint. Afterwards, the cyclists will do a 4 and a half hour training session at competition pace. After this training session, the participants will do the same time trial and the 30'' sprint.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketoses, Metabolic, Ketosis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone monoester
Arm Type
Experimental
Arm Description
Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Arm Title
Control product
Arm Type
Placebo Comparator
Arm Description
Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone monoester
Intervention Description
Consumption of 800mg/kg body weight of ketone monoester, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, every hour they should consume 90g of carbohydrates.
Intervention Type
Dietary Supplement
Intervention Name(s)
Control product consumption
Intervention Description
Consumption of placebo product (carbohydrates) masked with citric, divided in two intakes. The mixture will be prepared with bicarbonate. In addition, 90g of carbohydrates should be consumed every hour.
Primary Outcome Measure Information:
Title
Physical performance
Description
Measured using a power roller. Variables such as maximum power and average power
Time Frame
Change in performance after product consumption and training at a competitive level
Secondary Outcome Measure Information:
Title
Heart Rate
Description
Measured by a chest strap
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Microcapillary blood
Description
This test provides biochemical variables (ABL90FLEX) with 70 ml of capillary blood.
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Lactate
Description
Lactate levels will be measured using the Lactate Pro
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Ketone
Description
Will be measured by the FreeStyle Optium
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Blood glucose
Description
Will be measured by the FreeStyle Optium
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Blood glucose
Description
It will be measured continuously by Supersapiens.
Time Frame
It will be measured on a daily basis. Measurements will begin two days before the first performance test and end one day after the completion of the performance tests.
Title
Heart rate variability
Description
It will be measured for 5 minutes upon awakening.
Time Frame
It will be measured every morning. Measurements will be started two days before the first performance test and finished one day after the end of the performance tests.
Title
Stomach test
Description
It will be measured by means of a visual analog scale from 0 to 10 to determine the annoyance produced by the product (0: none and 10: maximum annoyance).
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
Title
Fatigue
Description
Rate of perceived exertion
Time Frame
It will be measured on four different occasions. Two on the first day (after one intake of product and after a second intake and training at competitive pace) and 4 days later, the same measurements but with the opposite product.
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male professional cyclists.
Start the study with previous rest.
Exclusion Criteria:
Participant suffering from chronic illness.
Suffering a long-term injury that prevents her from training in the month prior to the intervention.
Inability to understand the informed consent.
Having consumed ketone bodies chronically in the previous four weeks.
To have undergone cholecystectomy.
Facility Information:
Facility Name
Catholic University of Murcia
City
Murcia
ZIP/Postal Code
30107
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Acute Intake of Ketones on Performance in Professional Road Cyclists
We'll reach out to this number within 24 hrs