search
Back to results

Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes (MCT+AE)

Primary Purpose

Prediabetic State

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MCT
MCT+ aerobic exercise
Aerobic exercise
Control day
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Prediabetic State

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Healthy women

Women with prediabetes

Arm Description

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 control day with no MCT and no aerobic exercise. A 5 day consecutive MCT intake of 30 g/day. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 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.

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 control day with no MCT and no aerobic exercise. A 5 day consecutive MCT intake of 30 g/day. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
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)
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)

Full Information

First Posted
February 5, 2016
Last Updated
March 24, 2020
Sponsor
Université de Sherbrooke
search

1. Study Identification

Unique Protocol Identification Number
NCT02678390
Brief Title
Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes
Acronym
MCT+AE
Official Title
Stimulating the Production of Ketones Through the Combined Use of Aerobic Exercise (AE) and Dietary a Medium Chain Triglycerides (MCT) Supplement
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prediabetic State

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Healthy women
Arm Type
Experimental
Arm Description
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 control day with no MCT and no aerobic exercise. A 5 day consecutive MCT intake of 30 g/day. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 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.
Arm Title
Women with prediabetes
Arm Type
Experimental
Arm Description
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 control day with no MCT and no aerobic exercise. A 5 day consecutive MCT intake of 30 g/day. 30 minutes of aerobic exercise at 70% to 80% HRR of intensity. 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.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT
Intervention Description
A 5 day consecutive MCT intake of 30 g/day.
Intervention Type
Dietary Supplement
Intervention Name(s)
MCT+ aerobic exercise
Other Intervention Name(s)
MCT+AE
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
Aerobic exercise
Other Intervention Name(s)
AE
Intervention Description
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Intervention Type
Dietary Supplement
Intervention Name(s)
Control day
Other Intervention Name(s)
CTL
Intervention Description
No MCT or aerobic exercise
Primary Outcome Measure Information:
Title
Plasma Ketone Concentrations
Description
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 Outcome Measure Information:
Title
Plasma Glucose Concentrations
Description
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
Title
Plasma Triglyceride Concentrations
Description
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
Title
Plasma Free Fatty Acid Concentrations
Description
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
Title
Plasma Insulin Concentrations
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Cunnane, PhD
Organizational Affiliation
Research Centre on Aging, CIUSSS de l'Estrie-CHUS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

We'll reach out to this number within 24 hrs