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

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:

  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.
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:
  • MCT+AE
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Other Names:
  • AE
No MCT or aerobic exercise
Other Names:
  • CTL
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.
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:
  • MCT+AE
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Other Names:
  • AE
No MCT or aerobic exercise
Other Names:
  • CTL

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.

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

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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