Ketone Supplements and Substrate Oxidation and Physical Performance
Primary Purpose
Ketosis, Glucose Metabolism
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ketone ester
Glucose
Sponsored by
About this trial
This is an interventional other trial for Ketosis
Eligibility Criteria
Inclusion Criteria:
- Men and women aged 18 - 39 years
- Body mass index (BMI) < 30 kg/m2
- Routinely participate in aerobic and/or resistance exercise at least 2 days per week
- Refrain from the use of caffeine, alcohol, dietary supplements, and nicotine while consuming study diets
- Supervisor approval to participate for active duty military and federal civilian employees working within the US Army Natick Soldier Systems Center
Exclusion Criteria:
- Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
- Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
- Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy) to be utilized in the study or vegetarian practices
- Present condition of alcoholism, anabolic steroids, or other substance abuse issues
- Musculoskeletal injuries that compromise the ability to exercise
- Not willing to avoid non-study exercise and foods during each of the 3 day testing periods
- Blood donation within 8 weeks of beginning the study
- Pregnant or breast feeding
Sites / Locations
- USARIEM
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Ketone + Carbohydrate
Carbohydrate
Arm Description
573 mg/ kg body weight ketone ester + 110 g glucose
Isocaloric amount of glucose to match ketone + carbohydrate
Outcomes
Primary Outcome Measures
Time to exhaustion
Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by time to exhaustion at 85% VO2max on a treadmill compared to CHO alone
Time trial
Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by a self paced 4 mile time trial on a treadmill compared to CHO alone
Substrate oxidatoin
Determine the effect of KE + CHO supplementation on changes in substrate oxidation during moderate-intensity load carriage exercise compared to CHO alone.
Secondary Outcome Measures
Full Information
NCT ID
NCT04737694
First Posted
November 2, 2020
Last Updated
October 13, 2021
Sponsor
United States Army Research Institute of Environmental Medicine
1. Study Identification
Unique Protocol Identification Number
NCT04737694
Brief Title
Ketone Supplements and Substrate Oxidation and Physical Performance
Official Title
Impact of Ketone Ester Supplementation on Substrate Oxidation and Physical Performance
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
September 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
United States Army Research Institute of Environmental Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this randomized crossover study is to examine the influence of consuming a ketone ester plus carbohydrate (KE+CHO) supplement on substrate oxidation and physical performance in 15 healthy adults. Following a 48-hr muscle glycogen normalization period, volunteers will consume either an isocaloric KE+CHO (KE: 573 mg KE/kg body mass, CHO: 110 g) or isocaloric CHO drink and complete 90-min of metabolically-matched, load carriage (~30% body mass) steady-state aerobic (~60 ± 5 % of VO2peak) exercise on a treadmill. Glucose tracers will be used to assess glucose turnover, and contribution to exogenous and plasma glucose oxidation. Serial blood draws will be collected during each trial to assess endocrine and circulating substrate responses. After steady-state exercise volunteers will complete a time to exhaustion (TTE) physical performance tests at 85% VO2peak on a treadmill. Volunteers will then be provided with food for the remainder of the day. Following a 10-hr overnight fast, volunteers will return to the laboratory and consume the same supplement (KE+CHO or CHO) as they did the previous day. Volunteers will then perform a 4-mile load carriage time trial on a treadmill. Following a minimum 7-day washout period, volunteers will return to the laboratory to complete the second arm of the study. The primary risks associated with this study include those associated with exercise, blood draws, and gastrointestinal discomfort from the KE+CHO supplement.
Detailed Description
Following an overnight (10 hour) fast, two catheters will be placed into the lower arm (one in each arm). One arm will be used for infusion of 6,6-[2H2] glucose tracer and the other will be used for blood sampling under resting and exercise conditions. Following an initial blood sample collection to determine background enrichments, a primed, continuous infusion of 6,6-[2H2] glucose will begin (prime, 82.2 µmol∙kg-1; continuous rate, 0.78 µmol∙kg-1∙min-1, Figure 1). The 6,6-[2H2] glucose will be infused for 100 min under resting fasted conditions to ensure isotopic steady-state is achieved prior to initiating exercise. Volunteers will consume either an isocaloric KE+CHO (KE: 573 mg KE/kg body mass, CHO: 110 g) or CHO drink prior to and during 90-min of metabolically-matched (~60 ± 5 % of VO2peak), steady-state load carriage (~30% body mass) exercise. Drinks will be enriched with U-13C-glucose (Cambridge Isotope Laboratory, Andover, MA, USA) to increase the isotopic enrichment well above natural levels and optimize the measurement of exogenous carbohydrate oxidation. During exercise V̇O2, V̇CO2, and HR will be measured at approximately 0, 20, 45, 60, 75, and 85 min.
After the 90-min steady-state treadmill exercise, participants will complete a TTE performance test. For volunteer safety TTE performance tests will be conducted without the additional weight from the load carriage exercise. Volunteers will be given time to stretch and warm-up on the treadmill before the TTE performance test beings. Volunteers will then run on the treadmill at a fixed speed and grade that elicits 85% of their VO2peak. The TTE performance test will be determined as the time of volitional exhaustion. Following completion of the test, a self-selected cool-down will occur. Volunteers will complete a minimum of two practice exercise sessions to ensure they are familiar with the performance test.
The following day volunteers will return to the laboratory after an overnight fast. After consuming the study drink (KE+CHO or CHO) participants will complete a self-paced 4-mile load carriage (~30% body mass) time trial on a treadmill to assess aerobic performance. Time trial performance will be assessed as the total amount of time taken to complete 4 miles. The treadmill will be set at a constant 1% grade for the entire test. Following a warm-up period, volunteers will blindly modulate treadmill speed in order to complete the distance as quickly as possible. The only feedback given will be distance covered at half mile increments. At half mile increments volunteers' rate of perceived exertion will be determined using the Borg Scale. Heart rate will be monitored throughout the time trial. Heart rate will be recorded at half mile increments. No motivation will be provided during the time trial. Participants may consume water ad libitum during the time trial. Following completion of the test, a self-selected cool-down will occur. Volunteers will complete a minimum of two practice exercise sessions to ensure they are familiar with the performance test.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketosis, Glucose Metabolism
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Double blinded randomized crossover design
Masking
ParticipantInvestigator
Masking Description
Double blinded
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ketone + Carbohydrate
Arm Type
Experimental
Arm Description
573 mg/ kg body weight ketone ester + 110 g glucose
Arm Title
Carbohydrate
Arm Type
Active Comparator
Arm Description
Isocaloric amount of glucose to match ketone + carbohydrate
Intervention Type
Dietary Supplement
Intervention Name(s)
Ketone ester
Intervention Description
Oral ketone ester + glucose supplement
Intervention Type
Dietary Supplement
Intervention Name(s)
Glucose
Intervention Description
Glucose supplement
Primary Outcome Measure Information:
Title
Time to exhaustion
Description
Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by time to exhaustion at 85% VO2max on a treadmill compared to CHO alone
Time Frame
30 minutes
Title
Time trial
Description
Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by a self paced 4 mile time trial on a treadmill compared to CHO alone
Time Frame
120 minutes
Title
Substrate oxidatoin
Description
Determine the effect of KE + CHO supplementation on changes in substrate oxidation during moderate-intensity load carriage exercise compared to CHO alone.
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Men and women aged 18 - 39 years
Body mass index (BMI) < 30 kg/m2
Routinely participate in aerobic and/or resistance exercise at least 2 days per week
Refrain from the use of caffeine, alcohol, dietary supplements, and nicotine while consuming study diets
Supervisor approval to participate for active duty military and federal civilian employees working within the US Army Natick Soldier Systems Center
Exclusion Criteria:
Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy) to be utilized in the study or vegetarian practices
Present condition of alcoholism, anabolic steroids, or other substance abuse issues
Musculoskeletal injuries that compromise the ability to exercise
Not willing to avoid non-study exercise and foods during each of the 3 day testing periods
Blood donation within 8 weeks of beginning the study
Pregnant or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lee M Margolis, PhD
Organizational Affiliation
United States Army Research Institute of Environmental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
USARIEM
City
Natick
State/Province
Massachusetts
ZIP/Postal Code
01760
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Ketone Supplements and Substrate Oxidation and Physical Performance
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