Ignite Creation Date:
2024-05-06 @ 3:44 PM
Last Modification Date:
2024-10-26 @ 1:55 PM
Study NCT ID:
NCT04737694
Status:
UNKNOWN
Last Update Posted:
2021-10-14
First Post:
2020-11-02
Brief Title:
Ketone Supplements and Substrate Oxidation and Physical Performance
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Impact of Ketone Ester Supplementation on Substrate Oxidation and Physical Performance
Status:
UNKNOWN
Status Verified Date:
2021-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The objective of this randomized crossover study is to examine the influence of consuming a ketone ester plus carbohydrate KECHO 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 KECHO KE 573 mg KEkg 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 KECHO 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 KECHO 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 66-2H2 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 66-2H2 glucose will begin prime 822 µmolkg-1 continuous rate 078 µmolkg-1min-1 Figure 1 The 66-2H2 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 KECHO KE 573 mg KEkg 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 VO2 VCO2 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 KECHO 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
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 KECHO 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None