Recruiting

Optimized Carbohydrate Fueling

Sponsor:

United States Army Research Institute of Environmental Medicine

Code:

NCT06394401

Conditions

Energy Supply; Deficiency

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Interventions

BAL:GLU

BAL:GLU+FRU

DEF:GLU

DEF:GLU+FRU

Study Details

Brief summary:

This randomized crossover study will examine the effects of consuming isocaloric GLU+FRU 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 V̇O2peak. 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% V̇O2peak) exercise on a cycle ergometer. Immediately before and during steady-state exercise, volunteers will consume either 80 g of GLU+FRU (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 substrate/hormone 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.

Conditions

Energy Supply; Deficiency

Study ID

NCT06394401

Start date

Feb 1, 2024

Status verified date

Apr, 2024

Completion date

Dec 1, 2024

Anticipated

Primary completion date

Dec 1, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 39

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Men and women aged 18 - 39 years
  • Healthy without evidence of chronic illness or musculoskeletal injury as determined by the USARIEM Office of Medical Support and Oversight (OMSO) or home duty station medical support
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week
  • Willing to refrain from alcohol, smoking/using any nicotine product (includes e-cigarettes, vaping, chewing tobacco), caffeine, and dietary supplements while consuming the study diet
  • Supervisor approval for federal civilian employees and non-HRV active duty military personnel
  • Females must have normal menstrual cycles between 26-32 days in duration; 5 menstrual cycles within the past 6 months; or on continuous oral or IUD contraception without placebo.

Exclusion Criteria:

  • Musculoskeletal injuries that compromise exercise capability
  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.), claustrophobia
  • Significantly abnormal blood clotting as determined by OMSO or home duty station medical support
  • Allergy to lidocaine (or similar local anesthetic)
  • Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support
  • Blood donation within 8-wk of beginning the study
  • Pregnant, trying to become pregnant, and/or breastfeeding (results of urine pregnancy test and self-report for breastfeeding will be obtained before body composition testing)
  • Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
  • Unwilling or unable to adhere to study physical restrictions

Study Design

Enrollment

12 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Energy Balance: Glucose

Following 48 hours of consuming an energy balance diet, volunteers complete 80 min of steady-state (60 ± 5% V̇O2peak) exercise on a cycle ergometer while consuming 80 g of glucose

experimental: Energy Balance: Glucose plus Fructose

Following 48 hours of consuming an energy balance diet, volunteers complete 80 min of steady-state (60 ± 5% V̇O2peak) exercise on a cycle ergometer while consuming 53 g of glucose and 27 g of fructose.

active comparator: Energy Deficit: Glucose

Following 48 hours of consuming an energy deficit diet, volunteers complete 80 min of steady-state (60 ± 5% V̇O2peak) exercise on a cycle ergometer while consuming 80 g of glucose

experimental: Energy Deficit: Glucose plus Fructose

Following 48 hours of consuming an energy deficit diet, volunteers complete 80 min of steady-state (60 ± 5% V̇O2peak) exercise on a cycle ergometer while consuming 53 g of glucose and 27 g of fructose.

Interventions

BAL:GLU

80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet

BAL:GLU+FRU

53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet

DEF:GLU

80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet

DEF:GLU+FRU

53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet

Primary outcome measure

  • Exogenous carbohydrate oxidation [ Time Frame: 80 minutes ]

Central Contacts and Locations

Central contacts

Locations

USARIEM

Recruiting

Natick, Massachusetts, United States, 01760

Contacts

More Information

Sponsor

United States Army Research Institute of Environmental Medicine

Last update posted

May 1, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by United States Army Research Institute of Environmental Medicine on 2024-05-01.