Exogenous Ketones for Sleep in Healthy Subjects

(K-SLEEP Trial)

Overseen By Athena Mavronis, Associates of Science

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Johns Hopkins University

Must not be taking: Acetazolamide, SGLT2 inhibitors, Opioids

Disqualifiers: Sleep disorders, Respiratory impairment, Diabetes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assess how exogenous ketones (EK), such as the product Ketone-IQ, affect sleep in healthy individuals. Researchers seek to determine if EK can enhance sleep quality and how well the body tolerates it. Participants will take two different doses of EK before bedtime and report on their sleep experience and any side effects. The trial seeks healthy adults without known sleep disorders or respiratory issues, and who are not on low-carb or ketogenic diets. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking acetazolamide, SGLT2 inhibitors, or daily opioids.

Is there any evidence suggesting that this treatment is likely to be safe for humans?

Research has shown that Ketone-IQ, a type of supplement, has been studied for its effects on sleep and overall performance. Previous studies found that Ketone-IQ can improve sleep quality and efficiency, especially after intense exercise, suggesting it might be well-tolerated by active individuals.

Regarding safety, other studies examined Ketone-IQ's effects on the stomach and digestion. They found it is generally well-tolerated, with no major side effects reported, though some individuals experienced mild stomach discomfort. These findings provide reassurance about the safety of Ketone-IQ in humans.

Currently, an early-stage trial is testing Ketone-IQ, focusing mainly on safety and tolerability. While some evidence of safety exists, more research is needed to fully understand its effects and any possible side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard sleep aids, which often rely on sedative effects, Ketone-IQ offers a unique approach by using exogenous ketones to potentially enhance sleep quality. Researchers are excited about this because ketones serve as an alternative energy source for the brain, which may stabilize energy levels and support more restful sleep without the grogginess associated with traditional sleep medications. This novel mechanism presents a promising alternative, especially for those seeking to improve their sleep naturally.

What evidence suggests that Ketone-IQ might be an effective treatment for sleep?

Studies have shown that exogenous ketones, or ketones taken from outside the body, can improve sleep quality. Research indicates that these substances enhance sleep, particularly after exercise. In this trial, participants will receive either 20 g or 40 g of Ketone-IQ, a type of exogenous ketone, before bedtime to assess its impact on sleep. Ketone-IQ has been linked to better performance and reduced tiredness, potentially aiding recovery and sleep. Early findings suggest that increasing ketone levels in the body might help individuals feel more rested. Although more research is needed, these early signs are promising for those seeking to improve sleep with ketones. ^{1 2 3 4 6}

Who Is on the Research Team?

Jonathan Jun, MD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

This trial is for healthy volunteers, both men and women, who are interested in how a ketone supplement called Ketone-IQ might affect their sleep. Participants will take the supplement at home before sleeping. They must be willing to measure their blood ketone levels and wear a headband-EEG device overnight.

Inclusion Criteria

I am between 18 and 50 years old with a BMI between 18 and 30.

Exclusion Criteria

Cannot be pregnancy or breastfeeding

Cannot be on a low carbohydrate (<130 g carbohydrate/day) or ketogenic diet, intermittent fasting, or consuming exogenous ketones

K-BREATHE: no history of claustrophobia or panic disorder

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive Ketone-IQ in two doses (20 g and 40 g) before sleep to assess sleep effects and tolerability

1 week

Home-based assessments with multiple nights of data collection

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Ketone-IQ

Trial Overview The study is testing two different doses of Ketone-IQ (20g and 40g) on sleep quality and breathing patterns in healthy individuals. It aims to understand if taking this exogenous ketone can improve sleep or cause any changes in blood ketones without altering diet.

How Is the Trial Designed?

Group I: K-SLEEP Experimental Treatment 2 Interventions

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 Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

HVMN Inc

Industry Sponsor

Trials

3

Recruited

80+

KETONE-IQ

Collaborator

Trials

2

Recruited

60+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10581428/

Exogenous Ketosis Improves Sleep Efficiency and ... These data indicate that KE ingestion improves sleep efficiency and quality after high-intensity exercise.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224074

Impact of Exogenous Ketones on Sleep and Breathing ... 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 ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06655649

Impact of Exogenous Ketones on Sleep Disruption in ... In this pilot study, the investigators will examine the pharmacokinetics, tolerability, and impacts of ingesting exogenous ketones (which are commercially ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37259248/

Exogenous Ketosis Improves Sleep Efficiency and ... Conclusions: These data indicate that KE ingestion improves sleep efficiency and quality after high-intensity exercise. We provide preliminary ...

5. help.ketone.com help.ketone.com/article/h6u6uxy44a-effects-of-ketone-iq

What's the research behind Ketone-IQ? Ketone-IQ showed significant improvements in performance and decrease in fatigue. Recovery. Athletes who drank ketones for recovery and sleep ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S2475299125029415

The Effect of Exogenous Ketones on Signs and Symptoms ... This ongoing triple-blind, randomized controlled crossover trial investigates the effects of a single ingestion of KE on signs and symptoms of SSD and BD.