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

NCT07224074 | Recruiting Phase 1

• 1 other identifier: IRB00517978
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Participants; Sleep

Keywords

Sleep; Healthy; Ketones

Outcome Measures

Primary Outcomes (1)

• Beta hydroxybutyrate (BHB) maximal concentration (Cmax)

  Participants will measure their capillary BHB levels at home at 4 time points after ingestion (1, 3, 5 hours, and final awakening). The investigators will derive the maximal BHB concentration (mmol) of these timepoints. Measured on two occasions: Night 2 (Ketone IQ 20 g) and Night 5 (Ketone IQ 40 g).

  1, 3, 5 hours, and final awakening (Night 2); and 1, 3, 5 hours, and final awakening (Night 5)

Secondary Outcomes (5)

• Sleep quality as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) short from 8a

  day 2, day 4, and day 7

• Sleep quality as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment (SRI) short form 8a

  day 2, day 4, and day 7.

• Sleep quality as assessed by Stanford Sleepiness Scale

  3 questionnaires in 1 week on day 2, day 4, and day 7.

• Sleep architecture as assessed by minutes of sleep in each stage

  Night 1, Night 2, Night 3, Night 6

• Gastrointestinal tolerability as assessed by the Gastrointestinal Symptoms Questionnaire

  day 3, day 4, day 6, and day 7

Study Arms (1)

K-SLEEP

EXPERIMENTAL

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

Dietary Supplement: KETONE-IQ 20 grams (g); Dietary Supplement: KETONE-IQ 40 grams (g)

Interventions

KETONE-IQ 20 grams (g) DIETARY_SUPPLEMENT

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

K-SLEEP

KETONE-IQ 40 grams (g) DIETARY_SUPPLEMENT

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

K-SLEEP

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Johns Hopkins University: lead
• HVMN Inc: collaborator
• KETONE-IQ: collaborator

Study Sites (1)

Johns Hopkins Bayview

Baltimore, Maryland, 21224, United States

RECRUITING

MeSH Terms

Conditions

Ketosis

Condition Hierarchy (Ancestors)

Acidosis; Acid-Base Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Jonathan Jun, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mariah V Potocki, Bachelors of Science

CONTACT

410-550-2233; mchaney7@jhmi.edu

Athena Mavronis, Associates of Science

CONTACT

410-550-4588; amavron1@jh.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will take open-label Ketone IQ before bedtime at two different doses (20 or 40 g).

Study Record Dates

• First Submitted: October 30, 2025
• First Posted: November 3, 2025
• Study Start: December 18, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2028
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Deidentified scientific data included in published manuscripts will be made available at the time of publication, and additional data will be made available to researchers upon request. Data will be made available for up to 3 years following study completion.
• Access Criteria: To request access to the data, researchers will be able to contact Dr. Jonathan Jun via email. Any data attached as a supplement to publications will be available for download from the publisher's website. The intention is to allow qualified external investigators broad access to the study data for specified research purposes.

Locations

US (1)