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KetosisNCT04737694

Ketone Supplements and Substrate Oxidation and Physical Performance

A study testing Ketone ester and Glucose in people with Ketosis and Glucose Metabolism, run by United States Army Research Institute of Environmental Medicine at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The objective of this randomized crossover study is to examine the influence of consuming a ketone ester plus carbohydrate (KE+CHO) supplement on substrate oxidation and physical performance in 15 healthy adults. Read more about this study

Who is it for?
Ages 18 to 39 yearsHealthy volunteers can take part
Conditions the study is for
Ketosis, Glucose Metabolism
What is being tested?
Ketone ester and Glucose
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteUnited States
Study dates
1 Nov 2020to 1 Sep 2022
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
  • Body mass index (BMI) < 30 kg/m2
  • Routinely participate in aerobic and/or resistance exercise at least 2 days per week
  • Refrain from the use of caffeine, alcohol, dietary supplements, and nicotine while consuming study diets
  • Supervisor approval to participate for active duty military and federal civilian employees working within the US Army Natick Soldier Systems Center

Who cannot join

  • Metabolic or cardiovascular abnormalities, gastrointestinal disorders (i.e., kidney disease, diabetes, cardiovascular disease, etc.)
  • Disease or medication (i.e., diabetes medications, statins, corticosteroids, etc) that affects macronutrient utilization and/or the ability to participate in strenuous exercise
  • Allergies or intolerance to foods (including but not limited to lactose intolerance/milk allergy) to be utilized in the study or vegetarian practices
  • Present condition of alcoholism, anabolic steroids, or other substance abuse issues
  • Musculoskeletal injuries that compromise the ability to exercise
  • Not willing to avoid non-study exercise and foods during each of the 3 day testing periods
  • Blood donation within 8 weeks of beginning the study
  • Pregnant or breast feeding

Trial locations and contacts

1 site in 1 country.

United States1 site
  • USARIEM

    Natick, Massachusetts, 01760

Other trials in United States

About this study

Official title: Impact of Ketone Ester Supplementation on Substrate Oxidation and Physical Performance

The objective of this randomized crossover study is to examine the influence of consuming a ketone ester plus carbohydrate (KE+CHO) supplement on substrate oxidation and physical performance in 15 healthy adults. Following a 48-hr muscle glycogen normalization period, volunteers will consume either an isocaloric KE+CHO (KE: 573 mg KE/kg body mass, CHO: 110 g) or isocaloric CHO drink and complete 90-min of metabolically-matched, load carriage (~30% body mass) steady-state aerobic (~60 ± 5 % of VO2peak) exercise on a treadmill. Glucose tracers will be used to assess glucose turnover, and contribution to exogenous and plasma glucose oxidation. Serial blood draws will be collected during each trial to assess endocrine and circulating substrate responses. After steady-state exercise volunteers will complete a time to exhaustion (TTE) physical performance tests at 85% VO2peak on a treadmill. Volunteers will then be provided with food for the remainder of the day. Following a 10-hr overnight fast, volunteers will return to the laboratory and consume the same supplement (KE+CHO or CHO) as they did the previous day. Volunteers will then perform a 4-mile load carriage time trial on a treadmill. Following a minimum 7-day washout period, volunteers will return to the laboratory to complete the second arm of the study. The primary risks associated with this study include those associated with exercise, blood draws, and gastrointestinal discomfort from the KE+CHO supplement.

Read the detailed description

Following an overnight (10 hour) fast, two catheters will be placed into the lower arm (one in each arm). One arm will be used for infusion of 6,6-[2H2] glucose tracer and the other will be used for blood sampling under resting and exercise conditions. Following an initial blood sample collection to determine background enrichments, a primed, continuous infusion of 6,6-[2H2] glucose will begin (prime, 82.2 µmol∙kg-1; continuous rate, 0.78 µmol∙kg-1∙min-1, Figure 1). The 6,6-[2H2] glucose will be infused for 100 min under resting fasted conditions to ensure isotopic steady-state is achieved prior to initiating exercise. Volunteers will consume either an isocaloric KE+CHO (KE: 573 mg KE/kg body mass, CHO: 110 g) or CHO drink prior to and during 90-min of metabolically-matched (~60 ± 5 % of VO2peak), steady-state load carriage (~30% body mass) exercise. Drinks will be enriched with U-13C-glucose (Cambridge Isotope Laboratory, Andover, MA, USA) to increase the isotopic enrichment well above natural levels and optimize the measurement of exogenous carbohydrate oxidation. During exercise V̇O2, V̇CO2, and HR will be measured at approximately 0, 20, 45, 60, 75, and 85 min.

After the 90-min steady-state treadmill exercise, participants will complete a TTE performance test. For volunteer safety TTE performance tests will be conducted without the additional weight from the load carriage exercise. Volunteers will be given time to stretch and warm-up on the treadmill before the TTE performance test beings. Volunteers will then run on the treadmill at a fixed speed and grade that elicits 85% of their VO2peak. The TTE performance test will be determined as the time of volitional exhaustion. Following completion of the test, a self-selected cool-down will occur. Volunteers will complete a minimum of two practice exercise sessions to ensure they are familiar with the performance test.

The following day volunteers will return to the laboratory after an overnight fast. After consuming the study drink (KE+CHO or CHO) participants will complete a self-paced 4-mile load carriage (~30% body mass) time trial on a treadmill to assess aerobic performance. Time trial performance will be assessed as the total amount of time taken to complete 4 miles. The treadmill will be set at a constant 1% grade for the entire test. Following a warm-up period, volunteers will blindly modulate treadmill speed in order to complete the distance as quickly as possible. The only feedback given will be distance covered at half mile increments. At half mile increments volunteers' rate of perceived exertion will be determined using the Borg Scale. Heart rate will be monitored throughout the time trial. Heart rate will be recorded at half mile increments. No motivation will be provided during the time trial. Participants may consume water ad libitum during the time trial. Following completion of the test, a self-selected cool-down will occur. Volunteers will complete a minimum of two practice exercise sessions to ensure they are familiar with the performance test.

Being tested
Ketone ester, Glucose
Medical subject headings
Ketosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ketone esterDietary supplement

    Oral ketone ester + glucose supplement

  • GlucoseDietary supplement

    Glucose supplement

Study groups in NCT04737694
Study groupRoleWhat they receive
Ketone + CarbohydrateExperimental573 mg/ kg body weight ketone ester + 110 g glucose
Receives: Dietary Supplement: Ketone ester
CarbohydrateActive comparatorIsocaloric amount of glucose to match ketone + carbohydrate
Receives: Dietary Supplement: Glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to exhaustion

    Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by time to exhaustion at 85% VO2max on a treadmill compared to CHO alone

    Measured: 30 minutes

  2. Time trial

    Determine the effect of ketone esters plus carbohydrate (KE + CHO) supplementation on physical performance as determine by a self paced 4 mile time trial on a treadmill compared to CHO alone

    Measured: 120 minutes

  3. Substrate oxidatoin

    Determine the effect of KE + CHO supplementation on changes in substrate oxidation during moderate-intensity load carriage exercise compared to CHO alone.

    Measured: 90 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start1 Nov 2020
  3. Primary completion1 Jun 2021
  4. Study completion1 Sep 2022 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Double blinded randomized crossover design
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04737694
Sponsor's protocol ID
20-07HC
Status last verified
Oct 2021
First submitted
2 Nov 2020
Last updated
14 Oct 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Howard EE, Allen JT, Coleman JL, Small SD, Karl JP, O'Fallon KS, Margolis LM. Ketone Monoester Plus Carbohydrate Supplementation Does Not Alter Exogenous and Plasma Glucose Oxidation or Metabolic Clearance Rate During Exercise in Men Compared with Carbohydrate Alone. J Nutr. 2023 Jun;153(6):1696-1709. doi: 10.1016/j.tjnut.2023.03.002. Epub 2023 Mar 8.

    PubMed 36893935

Questions about this trial

What is this clinical trial studying?

A study testing Ketone ester and Glucose in people with Ketosis and Glucose Metabolism, 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 5 inclusion and 8 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 14 Oct 2021. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to exhaustion (time frame: 30 minutes). The study lists 3 primary outcomes in all. 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 NCT04737694, 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 14 Oct 2021.

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