Prediabetic StateMCT+AENCT02678390
Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes
A study testing MCT, MCT+ aerobic exercise and Aerobic exercise in people with Prediabetic State, run by Université de Sherbrooke at 1 site in Canada.
Trial summary
The aim of this study is to compare the effect on ketone production of dietary an MCT supplement combined or not with physical exercise in two groups of women (N=10/group), healthy adults and patients with prediabetes. Read more about this study
- Who is it for?
- Ages 60 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Prediabetic State
- What is being tested?
- MCT, MCT+ aerobic exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Sep 2017
- 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 60 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women group: fasting blood glucose < 6.1 mmol/L and HbA1c < 6.0 %.
- Women with prediabetes: fasting blood glucose between 6.1 and 6.9 mmol/L and HbA1c between 6.0 and 6.4 %
Who cannot join
- Structured physical activity (more than 2 times per week)
- Inability to practice physical exercise
- Diabetes (fasting glucose ≥ 7.0mmol/L or HbA1c ≥ 6.5%)
- Uncontrolled dyslipidemia or hypertension
- Use of medications known to affect the metabolism of lipids and carbohydrates (steroids, beta-blockers, diuretics, insulin sensitizers, etc.)
- Severe infections or inflammations
Trial locations and contacts
1 site in 1 country.
Canada1 site
Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
Sherbrooke, Quebec, J1H 4C4
About this study
Official title: Stimulating the Production of Ketones Through the Combined Use of Aerobic Exercise (AE) and Dietary a Medium Chain Triglycerides (MCT) Supplement
The aim of this study is to compare the effect on ketone production of dietary an MCT supplement combined or not with physical exercise in two groups of women (N=10/group), healthy adults and patients with prediabetes. After an evaluation of the metabolism (a 4-hour visit with multiple blood samples) at the beginning of the study, all the participants are taken for one-week the MCT supplement alone follow by a one-week period of taking the MCT supplement in combination with physical exercise. At the end of each period of time, the 4-hour visit for the evaluation of the metabolism is repeated.
- Conditions
- Prediabetic State
- Being tested
- MCT, MCT+ aerobic exercise, Aerobic exercise, Control day
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MCTDietary supplement
A 5 day consecutive MCT intake of 30 g/day.
MCT+ aerobic exerciseDietary supplement
Also called MCT+AE
A 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days.
Aerobic exerciseDietary supplement
Also called AE
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Control dayDietary supplement
Also called CTL
No MCT or aerobic exercise
| Study group | Role | What they receive |
|---|---|---|
| Healthy women | Experimental | Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.
Interventions:
1. A control day with no MCT and no aerobic exercise.
2. A 5 day consecutive MCT intake of 30 g/day.
3. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity.
4. A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days. Receives: Dietary Supplement: MCT; Dietary Supplement: MCT+ aerobic exercise; Dietary Supplement: Aerobic exercise; Dietary Supplement: Control day |
| Women with prediabetes | Experimental | Arm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling.
Interventions:
1. A control day with no MCT and no aerobic exercise.
2. A 5 day consecutive MCT intake of 30 g/day.
3. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity.
4. A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days. Receives: Dietary Supplement: MCT; Dietary Supplement: MCT+ aerobic exercise; Dietary Supplement: Aerobic exercise; Dietary Supplement: Control day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma Ketone Concentrations
Acetoacetate (umol/L) and beta-hydroxybutyrate (umol/L); Called Ketones (µmol/L) when combine together The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
Measured: 5 days
Secondary outcomes (4)
Plasma Glucose Concentrations
Glucose (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
Measured: 5 days
Plasma Triglyceride Concentrations
Triglycerides (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
Measured: 5 days
Plasma Free Fatty Acid Concentrations
Free fatty acids (mmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
Measured: 5 days
Plasma Insulin Concentrations
Insulin (nmol/L) measured in the plasma The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2016 (estimated)
- Study startSep 2015
- Primary completionSep 2017
- Study completionSep 2017
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 Prediabetic StateStudies 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
- 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
- Investigators
- Stephen Cunnane, PhD, Principal investigator, Research Centre on Aging, CIUSSS de l'Estrie-CHUS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02678390
- Sponsor's protocol ID
- 2015-508
- Acronym
- MCT+AE
- Status last verified
- Mar 2020
- First submitted
- 5 Feb 2016
- Last updated
- 7 Apr 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 7 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stimulating the Production of Ketones Through the Combined Use of Aerobic Exercise (AE) and Dietary a Medium Chain Triglycerides (MCT) Supplement
- ClinicalTrials.gov ID
- NCT02678390
- Acronym / sponsor ID
- MCT+AE / 2015-508
- Conditions
- Prediabetic State
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 9 Feb 2016 (estimated)
- Results
- Posted 7 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to compare the effect on ketone production of dietary an MCT supplement combined or not with physical exercise in two groups of women (N=10/group), healthy adults and patients with prediabetes. After an evaluation of the metabolism (a 4-hour visit with multiple blood samples) at the beginning of the study, all the participants are taken for one-week the MCT supplement alone follow by a one-week period of taking the MCT supplement in combination with physical exercise. At the end of each period of time, the 4-hour visit for the evaluation of the metabolism is repeated.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Healthy women | Experimental | Dietary Supplement: MCT, Dietary Supplement: MCT+ aerobic exercise, Dietary Supplement: Aerobic exercise, Dietary Supplement: Control dayArm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling. Interventions: 1. A control day with no MCT and no aerobic exercise. 2. A 5 day consecutive MCT intake of 30 g/day. 3. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 4. A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days. |
| Women with prediabetes | Experimental | Dietary Supplement: MCT, Dietary Supplement: MCT+ aerobic exercise, Dietary Supplement: Aerobic exercise, Dietary Supplement: Control dayArm: Evaluation of MCT, aerobic exercise alone and MCT+ aerobic exercise on glucose/ketone/lipid/insulin metabolism in 4-hour visits with repeated blood sampling. Interventions: 1. A control day with no MCT and no aerobic exercise. 2. A 5 day consecutive MCT intake of 30 g/day. 3. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 4. A 5 day consecutive MCT intake of 30 g/day in combination with 30 minutes of aerobic exercise (70% to 80% HRR)/ day for the five days. |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy women group: fasting blood glucose < 6.1 mmol/L and HbA1c < 6.0 %.
- Women with prediabetes: fasting blood glucose between 6.1 and 6.9 mmol/L and HbA1c between 6.0 and 6.4 %
Key exclusion criteria (6 listed)
- Structured physical activity (more than 2 times per week)
- Inability to practice physical exercise
- Diabetes (fasting glucose ≥ 7.0mmol/L or HbA1c ≥ 6.5%)
- Uncontrolled dyslipidemia or hypertension
- Use of medications known to affect the metabolism of lipids and carbohydrates (steroids, beta-blockers, diuretics, insulin sensitizers, etc.)
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 |
|---|---|---|
| MCTA 5 day consecutive MCT intake of 30 g/day. | Dietary supplement | Healthy women, Women with prediabetes |
| MCT+ aerobic exerciseAlso: MCT+AEA 5 day consecutive MCT intake of 30 g/day in combinaison with 30 minutes of aerobic exercise (70% to 80% HRR) per day for the five days. | Dietary supplement | Healthy women, Women with prediabetes |
| Aerobic exerciseAlso: AEA single period of 30 minutes of aerobic exercise (70% to 80% HRR). | Dietary supplement | Healthy women, Women with prediabetes |
| Control dayAlso: CTLNo MCT or aerobic exercise | Dietary supplement | Healthy women, Women with prediabetes |
Primary outcome
Plasma Ketone Concentrations
Time frame: 5 days
Acetoacetate (umol/L) and beta-hydroxybutyrate (umol/L); Called Ketones (µmol/L) when combine together The area under the curve (AUC) was calculated according to the trapezoidal method from 0 to 4 h during the visits (interventions) CTL = Metabolic study day (Day 1) MCT = Metabolic study day after 5 days of supplementation (Day 5) AE= Metabolic Study day after acute aerobic exercise (Day 6) AE + MCT = Metabolic Study day after 5 days of aerobic exercise and mct supplementation (Day 11)
4 secondary outcomes
Plasma Glucose Concentrations
Time frame: 5 days
Plasma Triglyceride Concentrations
Time frame: 5 days
Plasma Free Fatty Acid Concentrations
Time frame: 5 days
Plasma Insulin Concentrations
Time frame: 5 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 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, 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 MCT, MCT+ aerobic exercise and Aerobic exercise in people with Prediabetic State, 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 7 Apr 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 7 Apr 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?
Plasma Ketone Concentrations (time frame: 5 days). 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 7 Apr 2020.