NCT03659825

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 14, 2018

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2018

Completed
Last Updated

September 6, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

August 14, 2018

Last Update Submit

September 5, 2018

Conditions

HypoxiaKetosis

Outcome Measures

Primary Outcomes (6)

  • Change in Cognitive Performance- Visual Acuity

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

    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.

  • Change in Cognitive Performance- Contrast Sensitivity

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

    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.

  • 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 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.

  • 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 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.

  • 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 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.

  • 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 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)

  • Change in Grip Strength

    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.

  • Change in blood ketone levels

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

  • Change in blood glucose levels

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

Study Arms (4)

Placebo + Normoxia

PLACEBO COMPARATOR

Taste, volume and appearance matched drink given before cognitive testing in normoxia

Dietary Supplement: Taste Matched Placebo

Placebo + Hypoxia

PLACEBO COMPARATOR

Taste, volume and appearance matched drink given before cognitive testing in hypoxia

Dietary Supplement: Taste Matched PlaceboOther: Hypoxic exposure

Ketone Ester + Normoxia

EXPERIMENTAL

Ketone ester drink given before cognitive testing in normoxia

Dietary Supplement: Ketone Ester

Ketone Ester + Hypoxia

EXPERIMENTAL

Ketone ester drink given before cognitive testing in hypoxia

Dietary Supplement: Ketone EsterOther: Hypoxic exposure

Interventions

Ketone EsterDIETARY_SUPPLEMENT

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

Also known as: HVMN Ketone
Ketone Ester + HypoxiaKetone Ester + Normoxia
Taste Matched PlaceboDIETARY_SUPPLEMENT

Placebo that tastes similar to active intervention

Placebo + HypoxiaPlacebo + Normoxia
Hypoxic exposureOTHER

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

Ketone Ester + HypoxiaPlacebo + Hypoxia

Eligibility Criteria

Age18 Years - 45 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \* Pass medical examination on enrollment.

You may not qualify if:

  • \* Active smoker, substance abuse.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 29163194BACKGROUND

  • 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.

    PMID: 11700013BACKGROUND

  • 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.

    PMID: 6775394BACKGROUND

  • 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.

    PMID: 20204773BACKGROUND

Related Links

MeSH Terms

Conditions

HypoxiaKetosis

Interventions

formic acid 4-(3-oxobutyl)phenyl ester

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
Study drinks will be matched for taste and appearance. Investigator preparing and administering the drink will not carry out the testing.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Young healthy adults.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 14, 2018

First Posted

September 6, 2018

Study Start

September 1, 2018

Primary Completion

October 31, 2018

Study Completion

November 15, 2018

Last Updated

September 6, 2018

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share