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HypoxiaNCT03659825

Ketone Esters for Optimization of Cognitive Performance in Hypoxia

A study testing Ketone Ester and Hypoxic exposure in people with Hypoxia and Ketosis, run by HVMN Inc.

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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia. Read more about this study

Who is it for?
Ages 18 to 45 years, men onlyHealthy volunteers can take part
Conditions the study is for
Hypoxia, Ketosis
What is being tested?
Ketone Ester and Hypoxic exposure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
16 participants
Where
No sites listed yet
Study dates
1 Sep 2018to 15 Nov 2018
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 45 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Pass medical examination on enrollment.

Who cannot join

  • Active smoker, substance abuse.

About this study

This study will investigate the effects of ketone ester drinks on cognitive performance in hypoxia.

Read the detailed description

In the setting of altitude-induced hypoxia, cognitive capacity degrades and can compromise both individual and team performance. This degradation is linked to falling brain energy (ATP) levels and an increased reliance on anaerobic energy production from glucose. Ketone bodies are the evolutionary alternative substrate to glucose for brain metabolic requirements; previous studies have shown that the presence of elevated ketone bodies (ketosis) maintains brain ATP levels and reduce cerebral anaerobic glycolysis during hypoxia. Ketosis can be achieved when fasting or following a ketogenic diet; however, these approaches are impractical. Exogenous ketone ester supplementation allows for rapid (< 30 mins) and significant elevation of blood ketone levels without the need to maintain a diet or fast.

HVMN, in collaboration with researchers at IHMC, proposes a study to investigate the effects of consuming an FDA-approved ketone ester 'food' on cognitive performance in the setting of hypoxia. For the proposed 4-arm within-subject study, participants will complete a cognitive performance test battery under the conditions of normoxia and then hypoxia following consumption of a ketone ester drink or a placebo drink (N.B for each study drink cognitive performance in both hypoxia and normoxia will be assessed in ONE visit):

VISIT A:

Arm1: Normoxia + Placebo Arm 2: Hypoxia + Placebo

VISIT B:

Arm 3: Normoxia + Ketone ester Arm 4: Hypoxia + Ketone ester

The investigators hypothesize that ketone ester supplementation will attenuate hypoxia-induced deterioration of operator cognitive performance.

Conditions
Hypoxia, Ketosis
Being tested
Ketone Ester, Taste Matched Placebo, Hypoxic exposure
Medical subject headings
Hypoxia, Ketosis

What participants receive

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

  • Ketone EsterDietary supplement

    Also called HVMN Ketone

    Flavored sports drink containing deltaG (betahydroxybutyrate monoester) as the sole active ingredient, diluted with water.

  • Taste Matched PlaceboDietary supplement

    Placebo that tastes similar to active intervention

  • Hypoxic exposureOther

    Participants will breath through a mask to provide the amount of oxygen typically seen at 16-17,000ft of altitude.

Study groups in NCT03659825
Study groupRoleWhat they receive
Placebo + NormoxiaPlacebo comparatorTaste, volume and appearance matched drink given before cognitive testing in normoxia
Receives: Dietary Supplement: Taste Matched Placebo
Placebo + HypoxiaPlacebo comparatorTaste, volume and appearance matched drink given before cognitive testing in hypoxia
Receives: Dietary Supplement: Taste Matched Placebo; Other: Hypoxic exposure
Ketone Ester + NormoxiaExperimentalKetone ester drink given before cognitive testing in normoxia
Receives: Dietary Supplement: Ketone Ester
Ketone Ester + HypoxiaExperimentalKetone ester drink given before cognitive testing in hypoxia
Receives: Dietary Supplement: Ketone Ester; Other: Hypoxic exposure

What is being measured

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

  1. Change in Cognitive Performance- Visual Acuity

    Cognitive performance (visual acuity) will be assessed using the RightEye testing system (https://www.righteye.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

  2. Change in Cognitive Performance- Contrast Sensitivity

    Cognitive performance (contrast sensitivity) will be assessed using the RightEye testing system (https://www.righteye.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

  3. Change in Cognitive Performance- Choice Reaction Time

    Cognitive performance (choice reaction time) will be assessed using both the RightEye testing system (https://www.righteye.com) and the DANA testing system (http://www.danabrainvital.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

  4. Change in Cognitive Performance- Eye Tracking- Smooth Pursuit

    Cognitive performance (eye tracking) will be assessed by looking for smooth pursuit (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

  5. Change in Cognitive Performance- Eye Tracking- Saccades

    Cognitive performance (eye tracking) will be assessed by looking at saccade speed (horizontal and vertical) using the RightEye testing system (https://www.righteye.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

  6. Change in Cognitive Performance- Simple Reaction Time

    Cognitive performance (simple reaction time) will be assessed using both the RightEye testing system (https://www.righteye.com) and the DANA testing system (http://www.danabrainvital.com).

    Measured: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.

Secondary outcomes (3)

  1. Change in Grip Strength

    Grip strength will be measured using a

    Measured: Measured 3 times (baseline [time = 0 min], after normoxia [60 min post study drink 1] and after hypoxia [60 min post study drink 2]) in each of the two test visits.

  2. Change in blood ketone levels

    Blood ketone levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).

    Measured: Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]

  3. Change in blood glucose levels

    Blood glucose levels will be measured in a finger prick blood samples using a clinical grade, handheld glucose/ketone meter (Abott Diabetes Care).

    Measured: Measured 5 times at regular intervals through each of the two study visits. [time (min) = 0, 30, 75, 105, 150]

Timeline

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

  1. First posted6 Sep 2018
  2. Study start1 Sep 2018 (estimated)
  3. Primary completion31 Oct 2018 (estimated)
  4. Study completion15 Nov 2018 (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
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Young healthy adults.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
16 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03659825
Sponsor's protocol ID
KEHYPOX18
Status last verified
Aug 2018
First submitted
14 Aug 2018
Last updated
6 Sep 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Stubbs BJ, Cox PJ, Evans RD, Santer P, Miller JJ, Faull OK, Magor-Elliott S, Hiyama S, Stirling M, Clarke K. On the Metabolism of Exogenous Ketones in Humans. Front Physiol. 2017 Oct 30;8:848. doi: 10.3389/fphys.2017.00848. eCollection 2017.

    PubMed 29163194

  • Suzuki M, Suzuki M, Sato K, Dohi S, Sato T, Matsuura A, Hiraide A. Effect of beta-hydroxybutyrate, a cerebral function improving agent, on cerebral hypoxia, anoxia and ischemia in mice and rats. Jpn J Pharmacol. 2001 Oct;87(2):143-50. doi: 10.1254/jjp.87.143.

    PubMed 11700013

  • Kirsch JR, D'Alecy LG, Mongroo PB. Butanediol induced ketosis increases tolerance to hypoxia in the mouse. Stroke. 1980 Sep-Oct;11(5):506-13. doi: 10.1161/01.str.11.5.506.

    PubMed 6775394

  • Xu K, Sun X, Eroku BO, Tsipis CP, Puchowicz MA, LaManna JC. Diet-induced ketosis improves cognitive performance in aged rats. Adv Exp Med Biol. 2010;662:71-5. doi: 10.1007/978-1-4419-1241-1_9.

    PubMed 20204773

Questions about this trial

What is this clinical trial studying?

A study testing Ketone Ester and Hypoxic exposure in people with Hypoxia and Ketosis, run by HVMN Inc.

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 1 inclusion and 1 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 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Change in Cognitive Performance- Visual Acuity (time frame: Measured 3 times (baseline [time = 0 min], during normoxia [time = 30-60 min post study drink 1] and during hypoxia [30-60 min post study drink 2]) in each of the two test visits.). The study lists 6 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 NCT03659825, which also lists 4 linked publications.

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 6 Sep 2018.

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