Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)

NCT ID: NCT07224074

Last Updated: 2026-01-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-12-18
• Study Completion Date: 2028-01-01

Brief Summary

Ketones are molecules generated by the body during the metabolism of fat. Exogenous ketones (EK) are substances that can raise the level of ketones in the circulation without changing diet. In this research study, the investigators are testing the tolerability, sleep effects, and dose effects of a commercially available EK product called Ketone-IQ.

The investigators will administer Ketone-IQ open-label to healthy volunteers (n=20, 10 men, 10 women) before sleep in the participant's home setting and collect information about subjective sleep and GI symptoms, as well as objective data about beta-hydroxybutyrate (BHB) levels and sleep architecture using a headband-EEG device (Sleep Profiler). Participants will measure capillary BHB levels before ingestion and at 1, 3, and 5 hours post-ingestion, as well as upon awakening.

Questionnaires will be used to gather feedback on the palatability of EK, GI side effects, and sleep quality. Higher scores indicate better sleep quality. Two doses (20 g and 40 g) of Ketone-IQ will be tested each for two nights, with one night used to measure BHB levels and a separate night to allow for uninterrupted sleep.

Detailed Description

There is growing interest leveraging ketone metabolism for human health and performance. Exogenous ketones (EK) are substances that directly increase circulating ketones in the body without requiring a change in diet. While EK have been studied in the contexts of energy metabolism and exercise, few studies have examined EKs impact on sleep, a critical window for repair and rest. A mouse study showed that wakefulness increased brain ketones, while injection of acetoacetate increased slow wave sleep, suggesting a homeostatic sleep-promoting role of ketones. In humans, strenuous exercise reduced rapid eye movement (REM) sleep, which was prevented by ingestion of a ketone ester before sleep. Otherwise, few studies have systematically evaluated the effects of EK on sleep architecture and quality.

To examine the potential of EK to affect sleep, the investigators are conducting the K-SLEEP study. The investigators will examine sleep architecture and quality and BHB levels when EK are ingested prior to sleep (n=20). Healthy volunteers will ingest EK or placebo 30 minutes before sleep. Participants will measure capillary BHB levels before ingestion and at 1, 3, 5, hours post-ingestion as well as upon awakening. Questionnaires will solicit feedback about EK palatability, GI side effects, and sleep quality. Two doses will be examined, 20 g or 40 g with 1-2 days of washout between doses.

EK come in several forms including 1,3BD, ketone esters (beta-hydroxybutyrate + 1,3BD), fatty acid esters (C6 or C8 medium chain fatty acids + 1,3 BD), free acid ketones (beta-hydroxybutyric acid), and ketone salts (combination of ketone body with a mineral salt such as sodium or potassium). 1,3BD can be ingested in isolation or in a combination formulation (5, 6) whereupon it is absorbed and converted by hepatic enzymes into gamma-hydroxybutyrate and then oxidized to the ketone body BHB. In this study, the investigators will utilize a commercially available formulation of 1,3BD called Ketone IQ. This product has a more gradual onset and prolonged period of ketosis than ketone salt ingestion, making it more suitable for inducing sustained ketosis during several hours of sleep.

Conditions

Healthy Participants; Sleep

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

K-SLEEP

Healthy Participants will ingest (1) Ketone IQ 20 g or (2) Ketone IQ 40 g before bedtime and undergo objective and subjective sleep assessments.

Group Type: EXPERIMENTAL

KETONE-IQ 20 grams (g)

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 20g will be ingested (open-label) before bedtime.

KETONE-IQ 40 grams (g)

Intervention Type: DIETARY_SUPPLEMENT

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 40g will be ingested (open-label) before bedtime.

Interventions

KETONE-IQ 20 grams (g)

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 20g will be ingested (open-label) before bedtime.

Intervention Type: DIETARY_SUPPLEMENT

KETONE-IQ 40 grams (g)

Dietary Supplement: Ketone-IQ (1,3 Butanediol) Description: Ketone-IQ (1,3 Butanediol) 40g will be ingested (open-label) before bedtime.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• Adults aged 18-50 years old with a BMI of 18 - 30 kg/m^2

Exclusion Criteria

• No concomitant sleep disorder (e.g. sleep apnea, insomnia, restless leg syndrome, narcolepsy, idiopathic hypersomnia). If there is no known diagnosis of sleep apnea, a STOP-BANG score of 5 or higher is an exclusion.
• No current daytime respiratory impairment such as uncontrolled asthma, or uncontrolled Chronic Obstructive Pulmonary Disease (COPD), pneumonia, interstitial lung disease.
• No known history of chronic renal disease or diabetes (type 1 or type 2).
• No use of supplemental oxygen.
• Cannot be on a low carbohydrate (<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones
• Cannot be pregnancy or breastfeeding
• Cannot be on medications: acetazolamide or Sodium-glucose cotransporter-2 (SGLT2) inhibitor (10), daily opioid use.
• K-BREATHE: no history of claustrophobia or panic disorder
• Frequent alcohol intake (more than 1 drink per day on average, or > 10 drinks per week).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HVMN Inc

INDUSTRY

Sponsor Role: collaborator

KETONE-IQ

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jonathan Jun, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview

Baltimore, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Mariah V Potocki, Bachelors of Science

Role: CONTACT

mchaney7@jhmi.edu

410-550-2233

Athena Mavronis, Associates of Science

Role: CONTACT

amavron1@jh.edu

410-550-4588

Facility Contacts

Mariah V Potocki, Bachelors of Science

Role: primary

mchaney7@jhmi.edu

410-550-2233

Athena Mavronis, Associates of Science

Role: backup

amavron1@jh.edu

410-550-4588

Other Identifiers

IRB00517978

Identifier Type: -

Identifier Source: org_study_id