- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06394401
Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit
April 26, 2024 updated by: United States Army Research Institute of Environmental Medicine
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.
Study Overview
Status
Recruiting
Conditions
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 (GLU+FRU) 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 GLU+FRU 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 GLU+FRU 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 GLU+FRU (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 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.
Volunteers will complete all four trials (BAL: GLU, DEF: GLU, BAL: GLU+FRU, DEF: GLU+FRU) 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 Type
Interventional
Enrollment (Estimated)
12
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Lee M Margolis, PhD
- Phone Number: 508-206-2335
- Email: lee.m.margolis.civ@health.mil
Study Locations
-
-
Massachusetts
-
Natick, Massachusetts, United States, 01760
- Recruiting
- USARIEM
-
Contact:
- Lee M Margolis, PhD
- Phone Number: 508-206-2335
- Email: lee.m.margolis.civ@health.mil
-
-
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.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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
|
80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
|
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.
|
53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
|
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
|
80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
|
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.
|
53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Exogenous carbohydrate oxidation
Time Frame: 80 minutes
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to exhaustion
Time Frame: 20 minutes
|
Determine the effects of consuming glucose compared to glucose plus fructose on time to exhaustion (min) during a graded exercise performance test during energy balance and deficit.
|
20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start (Actual)
February 1, 2024
Primary Completion (Estimated)
December 1, 2024
Study Completion (Estimated)
December 1, 2024
Study Registration Dates
First Submitted
April 26, 2024
First Submitted That Met QC Criteria
April 26, 2024
First Posted (Actual)
May 1, 2024
Study Record Updates
Last Update Posted (Actual)
May 1, 2024
Last Update Submitted That Met QC Criteria
April 26, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23-15H
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Energy Supply; Deficiency
-
Swiss Paraplegic Centre NottwilCompletedEnergy Supply; DeficiencySwitzerland
-
United States Army Research Institute of Environmental...RecruitingStress, Physiological | Energy Supply; Deficiency | Energy Supply; Deficiency, SevereUnited States
-
Liverpool John Moores UniversityCompletedEnergy Supply; Deficiency | Carbohydrate AvailabilityUnited Kingdom
-
Liverpool John Moores UniversityAlliance for Potato Research and EducationCompletedEnergy Supply; Deficiency | Energy Balance | Energy AvailabilityUnited Kingdom
-
Brock UniversityNatural Sciences and Engineering Research Council, CanadaWithdrawnBone Loss | Energy Supply; DeficiencyCanada
-
Federal University of Minas GeraisConselho Nacional de Desenvolvimento Científico e Tecnológico; Fundação de...UnknownPostoperative Complications | Cancer | Surgery | Energy Supply; DeficiencyBrazil
-
SourseCitruslabsActive, not recruitingMood | Energy Supply; Deficiency | B12 Deficiency VitaminUnited States
-
University of BathUniversity of NottinghamActive, not recruitingAdiposity | Metabolic Disturbance | Fasting | Energy Supply; DeficiencyUnited Kingdom
-
Loughborough UniversityCompletedBone Resorption | Energy Supply; Deficiency | Female Athlete Triad | Relative Energy Deficiency in Sport | Bone AtrophyUnited Kingdom
-
Jens Rikardt AndersenDepartment of Oncology, Rigshospitalet, Blegdamsvej 9, 2100 CopenhagenUnknownWeight Loss | Abdominal Cancer | Radiotherapy; Complications | Protein Deficiency | Energy SupplyDenmark