RECRUITING

Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit

Quick Facts

Study Start:2024-02-01
Study Completion:2024-12-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06394401

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 39 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Men and women aged 18 - 39 years
  2. * 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
  3. * Routinely participate in aerobic and/or resistance exercise at least 2 days per week
  4. * 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
  5. * Supervisor approval for federal civilian employees and non-HRV active duty military personnel
  6. * 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.
  1. * Musculoskeletal injuries that compromise exercise capability
  2. * Metabolic or cardiovascular abnormalities, gastrointestinal disorders (e.g., kidney disease, diabetes, cardiovascular disease, etc.), claustrophobia
  3. * Significantly abnormal blood clotting as determined by OMSO or home duty station medical support
  4. * Allergy to lidocaine (or similar local anesthetic)
  5. * Present condition of alcoholism, anabolic steroid use, or other substance abuse issues as determined by OMSO or home duty station medical support
  6. * Blood donation within 8-wk of beginning the study
  7. * 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)
  8. * Unwilling or unable to consume study diets or foods provided due to personal preference, dietary restrictions, and/or food allergies
  9. * Unwilling or unable to adhere to study physical restrictions

Contacts and Locations

Study Contact

Lee M Margolis, PhD
CONTACT
508-206-2335
lee.m.margolis.civ@health.mil

Study Locations (Sites)

USARIEM
Natick, Massachusetts, 01760
United States

Collaborators and Investigators

Sponsor: United States Army Research Institute of Environmental Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-01
Study Completion Date2024-12-01

Study Record Updates

Study Start Date2024-02-01
Study Completion Date2024-12-01

Terms related to this study

Additional Relevant MeSH Terms

  • Energy Supply; Deficiency