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CompletedNCT02678390MCT+AEUpdated Apr 7, 2020Results posted

Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes

An interventional study of MCT and MCT+ aerobic exercise in Prediabetic State, sponsored by Université de Sherbrooke. Completed at 1 site in Canada. Open to female participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-04-07.

Sponsored by Université de Sherbrooke · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
20
Allocation
Non-randomized
Ages
60 Years and older
Sex
Female
01

Study 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. 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.

02

Conditions studied

  • Prediabetic State

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03

In context

Prediabetic State

999 studies on the registry are indexed under Prediabetic State; 238 are open to participants now.

This study's enrollment of 20 is below the median of 65 across 844 interventional studies indexed under Prediabetic State.

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Lead sponsor

Université de Sherbrooke is the lead sponsor of 289 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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 %

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Healthy women

    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.

    Dietary Supplement: MCT · Dietary Supplement: MCT+ aerobic exercise · Dietary Supplement: Aerobic exercise · Dietary Supplement: Control day

  • Experimental
    Women with prediabetes

    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.

    Dietary Supplement: MCT · Dietary Supplement: MCT+ aerobic exercise · Dietary Supplement: Aerobic exercise · Dietary Supplement: Control day

Interventions

  • Dietary supplementMCT

    A 5 day consecutive MCT intake of 30 g/day.

  • Dietary supplementMCT+ aerobic exercise

    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.

    Also known as: MCT+AE

  • Dietary supplementAerobic exercise

    A single period of 30 minutes of aerobic exercise (70% to 80% HRR).

    Also known as: AE

  • Dietary supplementControl day

    No MCT or aerobic exercise

    Also known as: CTL

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 5 days

Secondary outcomes

  1. 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)

    Time frame: 5 days

  2. 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)

    Time frame: 5 days

  3. 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)

    Time frame: 5 days

  4. 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)

    Time frame: 5 days

07

Results

Posted Apr 7, 2020

Participant flow

Control (5 Days)
Participant flow — Control (5 Days)
MilestoneHealthy WomenWomen With Prediabetes
Started1010
Completed1010
Not completed00
MCT (5 Days)
Participant flow — MCT (5 Days)
MilestoneHealthy WomenWomen With Prediabetes
Started1010
Completed1010
Not completed00
AE (1 Day)
Participant flow — AE (1 Day)
MilestoneHealthy WomenWomen With Prediabetes
Started1010
Completed109
Not completed01
Withdrew: Withdrawal by subject01
MCT + AE (5 Days)
Participant flow — MCT + AE (5 Days)
MilestoneHealthy WomenWomen With Prediabetes
Started109
Completed109
Not completed00

Outcome measures

PrimaryPlasma 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)

Time frame:
5 days
Reported as:
Mean · (µmol/h)/L
Plasma Ketone Concentrations
(µmol/h)/LHealthy WomenWomen With Prediabetes
CTL: AUC ketone-52 ± 11712 ± 96
MCT: AUC ketone493 ± 243627 ± 489
AE: AUC ketone122 ± 14623 ± 74
MCT+AE: AUC ketone835 ± 444663 ± 417
SecondaryPlasma 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)

Time frame:
5 days
Reported as:
Mean · (mmol*h)/L
Plasma Glucose Concentrations
(mmol*h)/LHealthy WomenWomen With Prediabetes
CTL: AUC glucose7.6 ± 1.411.0 ± 2.8
MCT: AUC glucose7.3 ± 1.311.6 ± 2.8
AE: AUC glucose7.6 ± 1.010.4 ± 3.0
MCT+AE: AUC glucose7.7 ± 1.510.3 ± 1.8
SecondaryPlasma 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)

Time frame:
5 days
Reported as:
Mean · (mmol*h)/L
Plasma Triglyceride Concentrations
(mmol*h)/LHealthy WomenWomen With Prediabetes
CTL: AUC triglycerides3.6 ± 0.63.8 ± 0.3
MCT: AUC triglycerides3.9 ± 0.43.5 ± 0.5
AE: AUC triglycerides4.0 ± 0.43.7 ± 0.7
MCT+AE: AUC triglycerides3.9 ± 0.63.5 ± 0.8
SecondaryPlasma 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)

Time frame:
5 days
Reported as:
Mean · (mmol*h)/L
Plasma Free Fatty Acid Concentrations
(mmol*h)/LHealthy WomenWomen With Prediabetes
CTL: AUC Free fatty acids1.3 ± 0.31.3 ± 0.6
MCT: AUC Free fatty acids1.3 ± 0.21.5 ± 0.4
AE: AUC Free fatty acids1.3 ± 0.21.4 ± 0.3
MCT+AE: AUC Free fatty acids1.4 ± 0.61.6 ± 0.3
SecondaryPlasma 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)

Time frame:
5 days
Reported as:
Mean · (nmol*h)/L
Plasma Insulin Concentrations
(nmol*h)/LHealthy WomenWomen With Prediabetes
CTL: AUC Insulin0.9 ± 0.50.8 ± 0.3
MCT: AUC Insulin0.8 ± 0.30.8 ± 0.8
AE: AUC Insulin0.8 ± 0.20.7 ± 0.3
MCT+AE: AUC Insulin0.7 ± 0.30.6 ± 0.2

Adverse events

Collected over 2 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Healthy Women0/10 (0%)0/10 (0%)0/10 (0%)
Women With Prediabetes0/9 (0%)0/9 (0%)0/9 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)Healthy WomenWomen With PrediabetesTotal
Mean67 ± 468 ± 568 ± 4
Sex: Female, Male
Sex: Female, Male(Participants)Healthy WomenWomen With PrediabetesTotal
Female10919
Male000
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Healthy WomenWomen With PrediabetesTotal
Count of participants——0
Region of Enrollment
Region of Enrollment(participants)Healthy WomenWomen With PrediabetesTotal
Canada10919
Body mass index
Body mass index(kg/m2)Healthy WomenWomen With PrediabetesTotal
Mean27 ± 328 ± 427 ± 4
Total body fat
Total body fat(% of body fat)Healthy WomenWomen With PrediabetesTotal
Mean43 ± 640 ± 442 ± 5
Plasma glucose
Plasma glucose(mmol/L)Healthy WomenWomen With PrediabetesTotal
Mean5.4 ± 0.16.1 ± 0.45.8 ± 0.3
Glycated hemoglobin
Glycated hemoglobin(% of glycated hemoglobin)Healthy WomenWomen With PrediabetesTotal
Mean5.7 ± 0.26.1 ± 0.25.9 ± 0.2

4 further baseline measures are reported on the registry.

08

Study locations

1 site
  • Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
    Sherbrooke, Quebec J1H 4C4, Canada
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Feb 1, 2016

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02678390
Lead sponsor
Université de Sherbrooke
Responsible party
Sponsor
First posted
Feb 9, 2016
Start date
Sep 2015
Primary completion
Sep 2017
Completion
Sep 2017
Results posted
Apr 7, 2020
Last update
Apr 7, 2020

Study contacts

Stephen Cunnane, PhD
principal investigator · Research Centre on Aging, CIUSSS de l'Estrie-CHUS

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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