KetonemiaOpti-MCTNCT03830268
Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants
A study testing No MCT intake with breakfast, no lunch, No MCT intake with lunch, no breakfast and 10g of Betaquik in people with Ketonemia, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ketonemia
- What is being tested?
- No MCT intake with breakfast, no lunch, No MCT intake with lunch, no breakfast and 10g of Betaquik
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 2 Jun 2017to 25 Jun 2019
- 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 10 health young (20-40 y old) and 10 health older (> 60 y old) participants
- Men and women
Who cannot join
- smoking
- diabetes (fasting glucose >7.0 mmol/l and glycated hemoglobin >6.9%)
- strenuous aerobic exercise more than three times a week
- untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function
- under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants
Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.
- Conditions
- Ketonemia
- Being tested
- No MCT intake with breakfast, no lunch, No MCT intake with lunch, no breakfast, 10g of Betaquik, 10g of Betaquik with low-carbs breakfast, 20g of Betaquik
- Keywords
- Ketones, Medium Chain Triglycerides, Glucose, Insulin, Free fatty acids
- 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.
No MCT intake with breakfast, no lunchDietary supplement
Also called CTL
Water given with a regular standardize breakfast and water given at noon without lunch.
No MCT intake with lunch, no breakfastDietary supplement
Also called CTL inverted
Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.
10g of BetaquikDietary supplement
Also called BQ10
BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.
10g of Betaquik with low-carbs breakfastDietary supplement
Also called BQ10LC
BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.
20g of BetaquikDietary supplement
Also called BQ20
BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.
10g of Betaquik with lunch, no breakfastDietary supplement
Also called BQ10 inverted
BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.
| Study group | Role | What they receive |
|---|---|---|
| MCT intake in young participants | Experimental | Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants.
Interventions:
1. No MCT intake with breakfast, no lunch (i.e. CTL)
2. No MCT intake with lunch, no breakfast (i.e CTL inverted)
3. 10g of Betaquik with breakfast, no lunch (i.e BQ10)
4. 20g of Betaquik with breakfast, no lunch (i.e BQ20)
5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)
6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted) Receives: Dietary Supplement: No MCT intake with breakfast, no lunch; Dietary Supplement: No MCT intake with lunch, no breakfast; Dietary Supplement: 10g of Betaquik; Dietary Supplement: 10g of Betaquik with low-carbs breakfast; Dietary Supplement: 20g of Betaquik; Dietary Supplement: 10g of Betaquik with lunch, no breakfast |
| MCT intake in older participants | Experimental | Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants.
Interventions:
1. No MCT intake with breakfast, no lunch (i.e. CTL)
2. No MCT intake with lunch, no breakfast (i.e CTL inverted)
3. 10g of Betaquik with breakfast, no lunch (i.e BQ10)
4. 20g of Betaquik with breakfast, no lunch (i.e BQ20)
5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC)
6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted) Receives: Dietary Supplement: 10g of Betaquik |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)
To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Measured: 8 hours
Secondary outcomes (3)
Concentration of plasma glucose
To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Measured: 8 hours
Concentration of plasma insulin
To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Measured: 8 hours
Concentration of plasma free fatty acids
To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2019
- Study start2 Jun 2017
- Primary completion25 Jun 2019
- Study completion25 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for KetonemiaStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- 10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03830268
- Sponsor's protocol ID
- 2017-714
- Acronym
- Opti-MCT
- Status last verified
- Mar 2020
- First submitted
- 1 Feb 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14.
PubMed 26766547Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.
PubMed 28709938Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.
PubMed 27629100Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.
PubMed 23274095Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.
PubMed 25147107
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
- Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants
- ClinicalTrials.gov ID
- NCT03830268
- Acronym / sponsor ID
- Opti-MCT / 2017-714
- Conditions
- Ketonemia
- Keywords
- Ketones, Medium Chain Triglycerides, Glucose, Insulin, Free fatty acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 25 Jun 2019 (actual)
- Study completion
- 25 Jun 2019 (actual)
- First posted
- 5 Feb 2019 (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.
Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)
| Arm | Type | Receives |
|---|---|---|
| MCT intake in young participants | Experimental | Dietary Supplement: No MCT intake with breakfast, no lunch, Dietary Supplement: No MCT intake with lunch, no breakfast, Dietary Supplement: 10g of Betaquik, Dietary Supplement: 10g of Betaquik with low-carbs breakfast, Dietary Supplement: 20g of Betaquik, Dietary Supplement: 10g of Betaquik with lunch, no breakfastDifferent conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants. Interventions: 1. No MCT intake with breakfast, no lunch (i.e. CTL) 2. No MCT intake with lunch, no breakfast (i.e CTL inverted) 3. 10g of Betaquik with breakfast, no lunch (i.e BQ10) 4. 20g of Betaquik with breakfast, no lunch (i.e BQ20) 5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted) |
| MCT intake in older participants | Experimental | Dietary Supplement: 10g of BetaquikDifferent conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants. Interventions: 1. No MCT intake with breakfast, no lunch (i.e. CTL) 2. No MCT intake with lunch, no breakfast (i.e CTL inverted) 3. 10g of Betaquik with breakfast, no lunch (i.e BQ10) 4. 20g of Betaquik with breakfast, no lunch (i.e BQ20) 5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 10 health young (20-40 y old) and 10 health older (> 60 y old) participants
- Men and women
Key exclusion criteria (5 listed)
- smoking
- diabetes (fasting glucose >7.0 mmol/l and glycated hemoglobin >6.9%)
- strenuous aerobic exercise more than three times a week
- untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function
- under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)
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 |
|---|---|---|
| No MCT intake with breakfast, no lunchAlso: CTLWater given with a regular standardize breakfast and water given at noon without lunch. | Dietary supplement | MCT intake in young participants |
| No MCT intake with lunch, no breakfastAlso: CTL invertedWater given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch. | Dietary supplement | MCT intake in young participants |
| 10g of BetaquikAlso: BQ10BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch. | Dietary supplement | MCT intake in older participants, MCT intake in young participants |
| 10g of Betaquik with low-carbs breakfastAlso: BQ10LCBQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch. | Dietary supplement | MCT intake in young participants |
| 20g of BetaquikAlso: BQ20BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch. | Dietary supplement | MCT intake in young participants |
| 10g of Betaquik with lunch, no breakfastAlso: BQ10 invertedBQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch. | Dietary supplement | MCT intake in young participants |
Primary outcome
Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)
Time frame: 8 hours
To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
3 secondary outcomes
Concentration of plasma glucose
Time frame: 8 hours
Concentration of plasma insulin
Time frame: 8 hours
Concentration of plasma free fatty acids
Time frame: 8 hours
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 25 Mar 2020.
- Background: PubMed 26766547Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14.
- Background: PubMed 28709938Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.
- Background: PubMed 27629100Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.
- Background: PubMed 23274095Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.
- Background: PubMed 25147107Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.
- Individual participant dataSharing planned: No
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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 No MCT intake with breakfast, no lunch, No MCT intake with lunch, no breakfast and 10g of Betaquik in people with Ketonemia, 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 5 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?
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?
Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate) (time frame: 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03830268, which also lists 5 linked publications.
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.