Johns Hopkins University partners with HVMN Inc. on a clinical trial investigating the impact of ketone supplementation on sleep and respiration dynamics in healthy individuals. The trial involves KETONE-IQ dietary supplements in two dosages.
The K-SLEEP clinical trial, sponsored by Johns Hopkins University alongside HVMN Inc., aims to assess the effects of exogenous ketones on sleep patterns and breathing regulation. Scheduled to launch, this study involves supplement interventions at controlled dosages in healthy participants. Stakeholders across clinical, regulatory, and quality sectors are encouraged to follow updates as the study progresses.
In this article:
- What are the Study Details?
- What are the Interventions?
- Who Will Benefit from This Research?
- Frequently Asked Questions
- Concluding Insights
- Disclaimer for Readers
What are the Study Details?
The K-SLEEP trial will examine how exogenous ketones, administered via dietary supplements, influence overall sleep behavior and respiratory health among healthy volunteers. The study parameters are governed by precision dosage control to ensure robust data collection.
This investigation adopts a prospective approach, with selection criteria intentionally restricted to individuals without pre-existing conditions, ensuring the reliability of observed outcomes within this defined demographic. The study will follow stringent protocols aligned with Good Clinical Practices (GCP).
What are the Interventions?
Ketone-IQ Dietary Supplements
Participants will receive one of two interventions:
- 20 grams of KETONE-IQ: A moderate dose expected to baseline the ketone impact.
- 40 grams of KETONE-IQ: A higher dose to further explore ketone efficiency and tolerability.
These interventions utilize proprietary technology incorporated into KETONE-IQ supplements, manufactured with advanced dietary formulation techniques approved for investigational use.
Who Will Benefit from This Research?
Healthcare practitioners, device manufacturers, and sleep regulation specialists will find potential applications for these findings within clinical care. Specifically, insights from this study could inform innovative approaches to sleep modulation devices or dietary regulations targeting respiratory efficiency.
Additionally, regulatory professionals may observe emerging trends in ketone-based supplementation research, valuable for future policy frameworks guiding nutritional interventions.
Frequently Asked Questions
- What makes dietary supplements part of clinical testing? Controlled trials help validate safety, dosage effects, and intended purpose under regulatory standards.
- Are participants required to be healthy? Yes, this study exclusively includes healthy volunteers to isolate the ketone supplementation’s effects away from confounding variables.
- Why were these dosages selected? The 20 g and 40 g dosages allow researchers to compare outcomes across two levels of exposure.
Concluding Insights
As current details indicate, the K-SLEEP trial promises valuable research into how ketone supplementation may intersect with sleep and respiratory regulation in healthy populations. These findings could support advancements in sleep-related healthcare solutions.
Regulatory teams are advised to monitor the trial for compliance adjustments concerning supplement-based investigations.
Disclaimer for Readers
This article contains general information for clinical professionals and should not replace legal advice on regulatory compliance or clinical trial management.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07224074?term=medical+device