Healthy AdultsNCT02693106
Evaluation of the Ketogenic Potential of Different Diet Supplements
A study testing Leucine, Butyrate - and Butyrate + in people with Healthy Adults, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults
- What is being tested?
- Leucine, Butyrate - and Butyrate +
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults aged of 18 years old or older.
- Non-smoking.
Who cannot join
- Diabetes or prediabetes
- Uncontrolled hypertension
- Uncontrolled thyroid function
- Taking medication that will affect lipid/glucose metabolism
- Severe infection or inflammation
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Centre on Aging (CSSS-IUGS - CIUSSS de l'Estrie - CHUS)
Sherbrooke, Quebec, J1H4C4
About this study
Official title: Stimulating the Ketogenesis by Using Nutritional Supplements
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.
Read the detailed description
The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.
- Conditions
- Healthy Adults
- Being tested
- Control, Leucine, Butyrate -, Butyrate +, Octanoate -
- Keywords
- Ketones, Butyrate, Leucine, Octanoate, Carnitine, Medium Chain Triglycerides
- Medical subject headings
- Ketosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ControlDietary supplement
Also called CTL
Visit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling.
LeucineDietary supplement
Visit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling.
Butyrate -Dietary supplement
Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Butyrate +Dietary supplement
Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling.
Octanoate -Dietary supplement
Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling.
Octanoate +Dietary supplement
Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling.
CarnitineDietary supplement
Visit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling.
Butter fractionDietary supplement
Visit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Ketogenic potential | Experimental | Each participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling.
Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT Receives: Dietary Supplement: Control; Dietary Supplement: Leucine; Dietary Supplement: Butyrate -; Dietary Supplement: Butyrate +; Dietary Supplement: Octanoate -; Dietary Supplement: Octanoate +; Dietary Supplement: Carnitine; Dietary Supplement: Butter fraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of Total Plasma Ketones
Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast.
Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken).
Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period.
For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones.
Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2016 (estimated)
- Study startJul 2013
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy AdultsStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe 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 N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephen Cunnane, PhD, Principal investigator, Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02693106
- Sponsor's protocol ID
- 2014-387
- Status last verified
- Mar 2020
- First submitted
- 23 Feb 2016
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Ketogenesis by Using Nutritional Supplements
- ClinicalTrials.gov ID
- NCT02693106
- Acronym / sponsor ID
- 2014-387
- Conditions
- Healthy Adults
- Keywords
- Ketones, Butyrate, Leucine, Octanoate, Carnitine, Medium Chain Triglycerides
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 26 Feb 2016 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Evaluate the capacity of different dietary supplements to increase ketone production in healthy adults.
Detailed description
The aim of this study is to evaluate the capacity of different dietary supplements to increase ketone production in healthy adults. Each supplement (leucine, butyrate, octanoate, carnitine or butter fraction rich in MCT) is evaluated for a period of 4-hour during which multiple blood samples are taken in order to measure ketone production.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ketogenic potential | Experimental | Dietary Supplement: Control, Dietary Supplement: Leucine, Dietary Supplement: Butyrate -, Dietary Supplement: Butyrate +, Dietary Supplement: Octanoate -, Dietary Supplement: Octanoate +, Dietary Supplement: Carnitine, Dietary Supplement: Butter fractionEach participant has to go through a total of 8 visits, each visit corresponding to a standardize breakfast taken alone (control visit) or with one of the dietary supplements evaluated followed by a period of 4-hour with multiple blood sampling. Intervention 1: Control; no supplement Intervention 2: 5 g of leucine Intervention 3: 3.6 g of butyrate Intervention 4: 7.2 g of butyrate Intervention 5: 5 g of octanoate Intervention 6: 10 g of octanoate Intervention 7: 1.95 g of carnitine Intervention 8: 65 g of butter fraction rich in MCT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adults aged of 18 years old or older.
- Non-smoking.
Key exclusion criteria (6 listed)
- Diabetes or prediabetes
- Uncontrolled hypertension
- Uncontrolled thyroid function
- Taking medication that will affect lipid/glucose metabolism
- Severe infection or inflammation
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 |
|---|---|---|
| ControlAlso: CTLVisit corresponding to a standardize breakfast taken alone (control visit) followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| LeucineVisit corresponding to a standardize breakfast with 5 g of leucine followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| Butyrate -Visit corresponding to a standardize breakfast with 3.6 g of butyrate followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| Butyrate +Visit corresponding to a standardize breakfast with 7.2 g of butyrate followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| Octanoate -Visit corresponding to a standardize breakfast with 5 g of octanoate followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| Octanoate +Visit corresponding to a standardize breakfast with 10 g of octanoate followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| CarnitineVisit corresponding to a standardize breakfast with 1.95 g of carnitine followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
| Butter fractionVisit corresponding to a standardize breakfast with 65 g of butter fraction followed by a period of 4-hour with multiple blood sampling. | Dietary supplement | Ketogenic potential |
Primary outcome
Concentration of Total Plasma Ketones
Time frame: 4 hours
Difference from Time 0 in Total ketones = acetoacetate (umol/L) + beta-hydroxybutyrate (umol/L) Time 0 is when the participants arrived, after a 12 hours fast, i.e. before the breakfast. Plasma was collected every 30 minutes for 4 hours immediately following breakfast (where supplements were taken). Results are the mean of plasma ketones measured every 30 minutes ( i.e. total of 9 plasma samples) for the 4 hour period. For each time point, the difference form time 0 has been made. So this is the mean of the difference from time 0 in total ketones. Data were not collected for the 'Intervention 8: 65 g of butter fraction rich in MCT' supplement.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Stephen Cunnane, PhD principal investigator
Research Centre on Aging CSSS-IUGS - CIUSSS de l'Estrie - CHUS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Leucine, Butyrate - and Butyrate + in people with Healthy Adults, run by Université de Sherbrooke at 1 site in Canada.
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 2 inclusion and 6 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 25 Mar 2020. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Concentration of Total Plasma Ketones (time frame: 4 hours). 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 25 Mar 2020.