Healthy Young AdultsNCT03452761
Effects of Exogenous Ketones in Healthy Young Adults
A study testing Ketone Salts in people with Healthy Young Adults, run by Augusta University at 1 site in United States.
Trial summary
Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Young Adults
- What is being tested?
- Ketone Salts
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2017to 27 Oct 2017
- Phase
- Interventional
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy (no known conditions)
Who cannot join
- Chronic smoker Pregnant
Trial locations and contacts
1 site in 1 country.
About this study
Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.
Read the detailed description
A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.
- Conditions
- Healthy Young Adults
- Being tested
- Ketone Salts
- Keywords
- exogenous ketone salts, ketosis, safety, comprehensive metabolic panel, complete blood count, lipid panel, insulin
- Medical subject headings
- Ketosis, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketone SaltsDietary supplement
Also called Exogenous Ketone Salts, Pruvit Keto OS
Subjects will take 2 servings of ketone salts daily for 6 weeks
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood health parameters
Comprehensive Metabolic Panel
Measured: 6 weeks on the supplement
Blood health parameter
Complete blood count
Measured: 6 weeks on the supplement
Blood health parameter
Lipid Panel
Measured: 6 weeks on the supplement
Blood health parameter
Insulin
Measured: 6 weeks on the supplement
Blood ketone levels
Blood ketones assessed 30- and 60 minutes after consuming the supplement
Measured: Baseline and 6 weeks after chronic consumption
Cardiovascular
Blood Pressure
Measured: 6 weeks on the supplement
Body Composition
Skinfold measure
Measured: 6 weeks on the supplement
Body Composition
Weight
Measured: 6 weeks on the supplement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2018
- Study start14 Jul 2017
- Primary completion27 Oct 2017
- Study completion27 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Young AdultsStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, 2-groups (condition and placebo)
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Augusta University
- Sponsor type
- University, hospital or other
- Collaborators
- Funding source: Pruvit Ventures, Inc
- Responsible party
- Principal investigator, Angelia Holland, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03452761
- Sponsor's protocol ID
- 10414835
- Status last verified
- Mar 2018
- First submitted
- 26 Feb 2018
- Last updated
- 2 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All data will be deidentified
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Exogenous Ketones in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT03452761
- Acronym / sponsor ID
- 10414835
- Conditions
- Healthy Young Adults
- Keywords
- exogenous ketone salts, ketosis, safety, comprehensive metabolic panel, complete blood count, lipid panel, insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Augusta UniversityUniversity, hospital or other
- Collaborators
- Funding source: Pruvit Ventures, Inc
- Study start
- 14 Jul 2017 (actual)
- Primary completion
- 27 Oct 2017 (actual)
- Study completion
- 27 Oct 2017 (actual)
- First posted
- 2 Mar 2018 (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.
Exogenous ketone supplements in the form of beta-hydroxybutyrate can be utilized as an alternate energy source (in place of glucose) for all cells except red blood cells. Exogenous ketone administration has been shown to be beneficial in terms of reducing oxidative stress, improving neuronal energy supplies, and maintaining normal blood glucose levels. The purpose of this study is to determine the effects and safety of supplementing with exogenous ketones for 6-weeks in healthy college-aged males and females. The results of this proposed study will determine whether exogenous ketone supplementation can be useful in promoting better body composition, energy levels, and blood cholesterol, glucose, and insulin levels.
Detailed description
A total of 22 subjects, male and female, were randomized to either a ketone salt group or a placebo group. Both the participants and investigators were blinded, as the supplements were coded by an external lab. Data was collected at baseline and again in 6-weeks. Participants consumed 2 servings of the assigned supplement daily for 6 weeks. Measures included body composition, blood pressure, questionnaires, blood work (comprehensive metabolic panel, complete blood count, and lipid panel), and a urinalysis. Also, blood ketone levels were assessed before and periodically after consuming the supplemental drink (30 and 60 minutes post drink). These measures were performed at both baseline and 6-weeks later.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Model description
- Randomized, double-blinded, 2-groups (condition and placebo)
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy (no known conditions)
Key exclusion criteria (1 listed)
- Chronic smoker Pregnant
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 SaltsAlso: Exogenous Ketone Salts, Pruvit Keto OSSubjects will take 2 servings of ketone salts daily for 6 weeks | Dietary supplement | – |
Primary outcome
Blood health parameters
Time frame: 6 weeks on the supplement
Comprehensive Metabolic Panel
Blood health parameter
Time frame: 6 weeks on the supplement
Complete blood count
Blood health parameter
Time frame: 6 weeks on the supplement
Lipid Panel
Blood health parameter
Time frame: 6 weeks on the supplement
Insulin
Blood ketone levels
Time frame: Baseline and 6 weeks after chronic consumption
Blood ketones assessed 30- and 60 minutes after consuming the supplement
Cardiovascular
Time frame: 6 weeks on the supplement
Blood Pressure
Body Composition
Time frame: 6 weeks on the supplement
Skinfold measure
Body Composition
Time frame: 6 weeks on the supplement
Weight
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 2 Mar 2018.
- Individual participant dataSharing planned: No. All data will be deidentified
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketone Salts in people with Healthy Young Adults, run by Augusta 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 1 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 2 Mar 2018. 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.
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?
Blood health parameters (time frame: 6 weeks on the supplement). The study lists 8 primary outcomes in all. 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 2 Mar 2018; AzTrials last refreshed its copy on 7 Nov 2026.