Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
18 participants
INTERVENTIONAL
2025-01-29
2025-05-12
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Ketogenic Diet for Reduction of CNS Oxygen Toxicity in Working Divers
NCT03433261
The Effect of Green Coffee Extract on Blood Glucose Homeostasis in Healthy Adults
NCT06137066
Short Term Ketone Supplementation and Cardiometabolic Health
NCT04236388
Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 1)
NCT05801120
Effects of Pre-dive Ketone Food Products on Latency to CNS Oxygen Toxicity (Aim 2)
NCT05831228
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
OTHER
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ketone Supplementation
Participants received 25g of BHB ketone ester and 4 mg/kg of caffeine.
Beta-Hydroxybutyrate
25 grams of BHB
Caffeine
4 mg/kg of caffeine
Control
Participants received 25g of carbohydrate and 4 mg/kg of caffeine.
Carbohydrate
25 grams of carbohydrate
Caffeine
4 mg/kg of caffeine
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Beta-Hydroxybutyrate
25 grams of BHB
Carbohydrate
25 grams of carbohydrate
Caffeine
4 mg/kg of caffeine
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Are in good general health (no active or uncontrolled diseases or conditions) and can ingest the assigned amount of fluid at each visit.
3. Have a body mass index (BMI) between 17.0 and 29.9 kg/m2 (inclusive).
4. Exercise regularly as per physical activity guidelines for Americans3 \[structured exercise for a minimum of 150 cumulative minutes per week (low end) to 500 cumulative minutes of exercise per week (high-end)\] and willing to maintain the same level of physical activity throughout the study period.
5. Can maintain their exercise status at the beginning of the study throughout the study period.
6. Can achieve a peak oxygen consumption at screening that is at least 55 ml/kg/min.
7. Have normal or acceptable to the investigator vital signs (BP and HR) at screening.
8. Able to agree to the requirements and restrictions of this study, willing to give voluntary consent, able to understand and read the questionnaires, and carry out all study-related procedures.
Exclusion Criteria
2. Carry a diagnosis of diabetes.
3. Weigh less than or equal to 80 pounds at any visits.
4. Answer "yes" to any of the questions asked on the screening questionnaire.
5. Have a history of a diagnosis of celiac disease, chronic pancreatitis, steatorrhea, unstable thyroid disease, major affective disorder, psychiatric disorder that required hospitalization in the prior year, immune disorder (i.e., HIV/AIDS), cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
6. Use any dietary supplements that may impact hydration status within the 30 days prior to the baseline visit (Familiarization Trial/Visit 2). Participants must observe a 30-day washout period of no supplementation to be eligible.
7. Consume more than two standard alcoholic drinks per day.
8. Use of inhalables, smokables, or the like (e.g., cigarettes, vaporizers, water pipes, or cannabis) within 30 days prior to the first dose of the study product or for the duration of the study.
9. Have a medical condition that may impact ability to exercise or ability to ingest prescribed fluid volume.
10. Smoking tobacco products.
11. Have a history of alcohol or substance abuse in the 12 months prior to the screening visit.
12. Are cognitively impaired and/or unable to give informed consent.
13. Have a known sensitivity, intolerability, or allergy to any of the study products or their excipients, or any of the rescue medications.
14. Have a current or previous diagnosis with SARS-CoV-2 in the three months prior to screening.
15. Have had major surgery three months prior to screening or have a planned major surgery during the course of the study.
16. Have received or use test product(s) in another research study in the 28 days prior to baseline visit, or longer if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of the current study.
17. Have any other active or unstable medical conditions or use medications, supplements, or therapies that, in the opinion of the investigator, may adversely affect the participant's ability to complete the study or its measures or pose a significant risk to the participant.
18 Years
35 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of South Carolina
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Shawn M. Arent
Professor and Chair of Exercise Science Department
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of South Carolina Sport Science Lab
Columbia, South Carolina, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Pro00139698
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.