Energy Supply; DeficiencyNCT06394401
Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit
A study testing BAL:GLU, BAL:GLU+FRU and DEF:GLU in people with Energy Supply; Deficiency, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 39 yearsHealthy volunteers can take part
- Conditions the study is for
- Energy Supply; Deficiency
- What is being tested?
- BAL:GLU, BAL:GLU+FRU and DEF:GLU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2024to 1 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 39 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
USARIEM
Natick, Massachusetts, 01760
Lee M Margolis, PhD, 508-206-2335, lee.m.margolis.civ@health.mil
About this study
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.
Read the 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.
- Conditions
- Energy Supply; Deficiency
- Being tested
- BAL:GLU, BAL:GLU+FRU, DEF:GLU, DEF:GLU+FRU
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAL:GLUDietary supplement
80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
BAL:GLU+FRUDietary supplement
53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
DEF:GLUDietary supplement
80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
DEF:GLU+FRUDietary supplement
53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: 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 Receives: 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. Receives: Dietary Supplement: DEF:GLU+FRU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 80 minutes
Secondary outcomes (1)
Time to exhaustion
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.
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2024
- Study start1 Feb 2024
- Primary completion1 Dec 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Energy Supply; DeficiencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double blinded randomized crossover design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United States Army Research Institute of Environmental Medicine
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06394401
- Sponsor's protocol ID
- 23-15H
- Status last verified
- Apr 2024
- First submitted
- 26 Apr 2024
- Last updated
- 1 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barney DE Jr, Panik KN, Michalak J, Wilson MA, Carrigan CT, Murphy NE, Drummer DJ, Margolis LM. Exogenous Carbohydrate Oxidation Is Higher When Consuming Glucose + Fructose Compared with Glucose Alone during Endurance Exercise Regardless of Energy Status. J Nutr. 2026 Jul;156(7):101593. doi: 10.1016/j.tjnut.2026.101593. Epub 2026 May 13.
PubMed 42134413
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Carbohydrate Fueling to Enhance Physical Performance During Energy Deficit
- ClinicalTrials.gov ID
- NCT06394401
- Acronym / sponsor ID
- 23-15H
- Conditions
- Energy Supply; Deficiency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- United States Army Research Institute of Environmental MedicineUS federal agency
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 1 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Double blinded randomized crossover design
| Arm | Type | Receives |
|---|---|---|
| Energy Balance: Glucose | Active comparator | Dietary Supplement: BAL:GLUFollowing 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 |
| Energy Balance: Glucose plus Fructose | Experimental | Dietary Supplement: BAL:GLU+FRUFollowing 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. |
| Energy Deficit: Glucose | Active comparator | Dietary Supplement: DEF:GLUFollowing 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 |
| Energy Deficit: Glucose plus Fructose | Experimental | Dietary Supplement: DEF:GLU+FRUFollowing 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. |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAL:GLU80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet | Dietary supplement | Energy Balance: Glucose |
| BAL:GLU+FRU53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet | Dietary supplement | Energy Balance: Glucose plus Fructose |
| DEF:GLU80 g glucose consumed during steady-state exercise following 48 hours of consuming an energy balance diet | Dietary supplement | Energy Deficit: Glucose |
| DEF:GLU+FRU53 g glucose plus 27 g fructose consumed during steady-state exercise following 48 hours of consuming an energy balance diet | Dietary supplement | Energy Deficit: Glucose plus Fructose |
Primary outcome
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.
1 secondary outcome
Time to exhaustion
Time frame: 20 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2024.
- Derived from this study: PubMed 42134413Barney DE Jr, Panik KN, Michalak J, Wilson MA, Carrigan CT, Murphy NE, Drummer DJ, Margolis LM. Exogenous Carbohydrate Oxidation Is Higher When Consuming Glucose + Fructose Compared with Glucose Alone during Endurance Exercise Regardless of Energy Status. J Nutr. 2026 Jul;156(7):101593. doi: 10.1016/j.tjnut.2026.101593. Epub 2026 May 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAL:GLU, BAL:GLU+FRU and DEF:GLU in people with Energy Supply; Deficiency, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lee M Margolis, PhD (508-206-2335, lee.m.margolis.civ@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exogenous carbohydrate oxidation (time frame: 80 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06394401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2024.