Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit

NCT06394401 | Recruiting

• 1 other identifier: 23-15H
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Exogenous carbohydrate oxidation

  Determine the effects of consuming glucose compared to glucose plus fructose on the rate (g/min) of exogenous carbohydrate oxidation during metabolically-matched steady-state exercise during energy balance and deficit.

  80 minutes

Secondary Outcomes (1)

• Time to exhaustion

  20 minutes

Study Arms (4)

Energy Balance: Glucose

ACTIVE COMPARATOR

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

Dietary Supplement: BAL:GLU

Energy Balance: Glucose plus Fructose

EXPERIMENTAL

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.

Dietary Supplement: BAL:GLU+FRU

Energy Deficit: Glucose

ACTIVE COMPARATOR

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

Dietary Supplement: DEF:GLU

Energy Deficit: Glucose plus Fructose

EXPERIMENTAL

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.

Dietary Supplement: DEF:GLU+FRU

Interventions

BAL:GLU DIETARY_SUPPLEMENT

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

Energy Balance: Glucose

BAL:GLU+FRU DIETARY_SUPPLEMENT

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

Energy Balance: Glucose plus Fructose

DEF:GLU DIETARY_SUPPLEMENT

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

Energy Deficit: Glucose

DEF:GLU+FRU DIETARY_SUPPLEMENT

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

Energy Deficit: Glucose plus Fructose

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• United States Army Research Institute of Environmental Medicine: lead

Study Sites (1)

USARIEM

Natick, Massachusetts, 01760, United States

RECRUITING

Central Study Contacts

Lee M Margolis, PhD

CONTACT

508-206-2335; lee.m.margolis.civ@health.mil

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: Double blinded randomized crossover design

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 1, 2024
• Study Start: February 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: May 1, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)