- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02678390
Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes (MCT+AE)
March 24, 2020 updated by: Université de Sherbrooke
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Quebec
-
Sherbrooke, Quebec, Canada, J1H 4C4
- Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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:
|
A 5 day consecutive MCT intake of 30 g/day.
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.
Other Names:
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Other Names:
No MCT or aerobic exercise
Other Names:
|
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:
|
A 5 day consecutive MCT intake of 30 g/day.
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.
Other Names:
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Other Names:
No MCT or aerobic exercise
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Plasma Glucose Concentrations
Time Frame: 5 days
|
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)
|
5 days
|
Plasma Triglyceride Concentrations
Time Frame: 5 days
|
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)
|
5 days
|
Plasma Free Fatty Acid Concentrations
Time Frame: 5 days
|
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)
|
5 days
|
Plasma Insulin Concentrations
Time Frame: 5 days
|
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)
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Stephen Cunnane, PhD, Research Centre on Aging, CIUSSS de l'Estrie-CHUS
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2015
Primary Completion (Actual)
September 1, 2017
Study Completion (Actual)
September 1, 2017
Study Registration Dates
First Submitted
February 5, 2016
First Submitted That Met QC Criteria
February 8, 2016
First Posted (Estimate)
February 9, 2016
Study Record Updates
Last Update Posted (Actual)
April 7, 2020
Last Update Submitted That Met QC Criteria
March 24, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-508
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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