Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:28 PM
Study NCT ID:
NCT06394401
Status:
RECRUITING
Last Update Posted:
2024-05-01
First Post:
2024-04-26
Brief Title:
Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit
Sponsor:
United States Army Research Institute of Environmental Medicine
Organization:
United States Army Research Institute of Environmental Medicine
Study Overview
Official Title:
Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
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:
This randomized crossover study will examine the effects of consuming isocaloric GLUFRU or GLU alone on rates of exogenous carbohydrate oxidation during aerobic exercise and physical performance time trial under energy balance BAL and energy deficit DEF Baseline data will be collected on volunteer height weight body composition and VO2peak To ensure volunteers are familiar with exercise protocols they will complete practice sessions of all exercise before the start of data collection Exercise and diet will be controlled throughout data collection To start the protocol volunteers will complete a bout of glycogen normalization on a cycle ergometer followed by 48 hours of refeeding at 100 BAL or 50 DEF of their energy needs After the 48 hours of refeeding volunteers will return to the laboratory to complete 80 min of steady-state 60 5 VO2peak exercise on a cycle ergometer Immediately before and during steady-state exercise volunteers will consume either 80 g of GLUFRU 53 g glucose 27 g fructose or 80 g GLU Drinks containing corn-derived crystalline fructose KRYSTAR 300 Tate and Lyle Sugars London UK and glucose CERELOSE Ingredion Westchester IL USA will be prepared by unblinded USARIEM staff Drinks will be enriched with 13C stable isotopes Cambridge Isotope Laboratory Andover MA USA to measure exogenous and plasma carbohydrate oxidation during steady-state exercise After steady-state exercise physical performance will be assessed using a graded exercise test on a stationary bike Indirect calorimetry and breath sampling will be used to determine substrate oxidation during steady-state exercise Serial blood draws will be collected during each trial to assess isotope enrichments and circulating substratehormone responses Muscle biopsies will be performed before and after steady-state exercise to assess glycogen status enzyme activity and molecular regulation of substrate metabolism There will be a minimum of 7 days between each carbohydrate metabolism study day
Detailed Description:
Periods of energy deficit DEF contribute to declines in physical performance during military operations During DEF glucose GLU supplementation alone is likely an insufficient intervention to enhance physical performance The lack of an ergogenic effect with GLU consumption during DEF may result from lower glucose uptake and exogenous glucose oxidation in peripheral tissue As the current carbohydrate beverage base in Meals Ready-to-Eat MRE is derived solely from GLU an alternative ration product may be needed to enhance physical performance during DEF Use of multiple transportable carbohydrates such as glucose plus fructose GLUFRU may be a more effective ration product as it has been shown to increase rates of exogenous carbohydrate oxidation and improve physical performance compared to GLU However previous studies have only been conducted during energy balance BAL and the influence of GLUFRU on substrate oxidation and physical performance compared to GLU during DEF is currently unknown This randomized crossover placebo controlled double blinded study will examine the effects of consuming GLU compared to GLUFRU on substrate oxidation and physical performance during metabolically-matched steady-state exercise during BAL and DEF Twelve healthy recreationally active men and women between the ages of 18-39 yrs will be required to complete this study To start the protocol volunteers will complete a bout of glycogen normalization cycling followed by 48 hours of refeeding at 100 BAL or 50 DEF of their energy needs After the 48 hours refeeding volunteers will return to the laboratory and complete 80 min of steady-state 60 5 VO2peak cycling Immediately before and during steady-state exercise volunteers will consume either 80 g of GLUFRU 53 g glucose 27 g fructose or 80 g GLU Drinks will be enriched with 13C stable isotopes to measure exogenous carbohydrate oxidation during steady-state exercise After steady-state exercise aerobic performance will be assessed Indirect calorimetry and breath sampling will be used to determine substrate oxidation during steady-state exercise Serial blood draws will be collected during each trial to assess isotope enrichments and circulating substratehormone responses Muscle biopsies will be performed before and after steady-state exercise to assess glycogen status enzyme activity and molecular regulation of substrate metabolism Volunteers will complete all four trials BAL GLU DEF GLU BAL GLUFRU DEF GLUFRU in a randomized order under controlled laboratory conditions at USARIEM There will be a minimum of 7 days between each carbohydrate metabolism study day
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