Healthy ParticipantsPhase 1K-SLEEPNCT07224074
Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-SLEEP)
A Phase 1 study testing KETONE-IQ 20 grams (g) and KETONE-IQ 40 grams (g) in people with Healthy Participants and Sleep, run by Johns Hopkins University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Sleep
- What is being tested?
- KETONE-IQ 20 grams (g) and KETONE-IQ 40 grams (g)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2025to 3 Sep 2026
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adults aged 18-50 years old with a BMI of 18 - 30 kg/m^2
Who cannot join
- 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
Show all 9Show fewer
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-EFFECTS)
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.
Read the 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
- Being tested
- KETONE-IQ 20 grams (g), KETONE-IQ 40 grams (g)
- Keywords
- Sleep, Healthy, Ketones
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: KETONE-IQ 20 grams (g); Dietary Supplement: KETONE-IQ 40 grams (g) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Modified PROMIS-SD short form 8a: Uses a Likert-type response scale. The raw score range is 8 to 40 with a higher score indicating greater severity of sleep disturbance.
Measured: 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
Modified PROMIS-SRI short form 8a: uses a Likert-type response scale. The raw score range is 8 to 40 with a higher score indicating greater severity of sleep related impairment.
Measured: day 2, day 4, and day 7.
Sleep quality as assessed by Stanford Sleepiness Scale
Stanford Sleepiness Scale; Total score range: 0-7. 7 Sleep quality 7 being the worst
Measured: 3 questionnaires in 1 week on day 2, day 4, and day 7.
Sleep architecture as assessed by minutes of sleep in each stage
Measured using a Sleep Profiler device, the Sleep Profiler provides automated sleep staging validated against polysomnography (PSG), using EEG signals to quantify time spent in each sleep stage. Worn for about 8 hours each night.
Measured: Night 1, Night 2, Night 3, Night 6
Gastrointestinal tolerability as assessed by the Gastrointestinal Symptoms Questionnaire
Questionnaire about GI tolerability of product; 0-8, 8 being "unbearable"
Measured: day 3, day 4, day 6, and day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2025
- Study start18 Dec 2025
- Primary completion3 Sep 2026
- Study completion3 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will take open-label Ketone IQ before bedtime at two different doses (20 or 40 g).
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- HVMN Inc, KETONE-IQ
- Responsible party
- Sponsor
- Investigators
- Jonathan Jun, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07224074
- Sponsor's protocol ID
- IRB00517978
- Acronym
- K-SLEEP
- Status last verified
- Sep 2026
- First submitted
- 30 Oct 2025
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified data will be provided at publication, accompanied by a data dictionary, and preserved for at least five years. De-identified experimental data, including sleep data, questionnaires, and BHB measurements may be shared by the PI upon reasonable requested.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Exogenous Ketones on Sleep and Breathing in Healthy Volunteers (K-EFFECTS)
- ClinicalTrials.gov ID
- NCT07224074
- Acronym / sponsor ID
- K-SLEEP / IRB00517978
- Conditions
- Healthy Participants, Sleep
- Keywords
- Sleep, Healthy, Ketones
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- HVMN Inc, KETONE-IQ
- Study start
- 18 Dec 2025 (actual)
- Primary completion
- 3 Sep 2026 (actual)
- Study completion
- 3 Sep 2026 (actual)
- First posted
- 3 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will take open-label Ketone IQ before bedtime at two different doses (20 or 40 g).
| Arm | Type | Receives |
|---|---|---|
| K-SLEEP | Experimental | Dietary Supplement: KETONE-IQ 20 grams (g), Dietary Supplement: KETONE-IQ 40 grams (g)Healthy Participants will ingest (1) Ketone IQ 20 g or (2) Ketone IQ 40 g before bedtime and undergo objective and subjective sleep assessments. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Adults aged 18-50 years old with a BMI of 18 - 30 kg/m^2
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | K-SLEEP |
| 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. | Dietary supplement | K-SLEEP |
Primary outcome
Beta hydroxybutyrate (BHB) maximal concentration (Cmax)
Time frame: 1, 3, 5 hours, and final awakening (Night 2); and 1, 3, 5 hours, and final awakening (Night 5)
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).
5 secondary outcomes
Sleep quality as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance (SD) short from 8a
Time frame: 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
Time frame: day 2, day 4, and day 7.
Sleep quality as assessed by Stanford Sleepiness Scale
Time frame: 3 questionnaires in 1 week on day 2, day 4, and day 7.
Sleep architecture as assessed by minutes of sleep in each stage
Time frame: Night 1, Night 2, Night 3, Night 6
Gastrointestinal tolerability as assessed by the Gastrointestinal Symptoms Questionnaire
Time frame: day 3, day 4, day 6, and day 7
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: Yes. Deidentified data will be provided at publication, accompanied by a data dictionary, and preserved for at least five years. De-identified experimental data, including sleep data, questionnaires, and BHB measurements may be shared by the PI upon reasonable requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Jun, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KETONE-IQ 20 grams (g) and KETONE-IQ 40 grams (g) in people with Healthy Participants and Sleep, run by Johns Hopkins University 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 1 inclusion and 9 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: finished, as of the sponsor's last update on 28 Sep 2026. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Beta hydroxybutyrate (BHB) maximal concentration (Cmax) (time frame: 1, 3, 5 hours, and final awakening (Night 2); and 1, 3, 5 hours, and final awakening (Night 5)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.