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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02678390
Other study ID # 2015-508
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date September 2017

Study information

Verified date March 2020
Source Université de Sherbrooke
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
MCT
A 5 day consecutive MCT intake of 30 g/day.
MCT+ 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.
Aerobic exercise
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
Control day
No MCT or aerobic exercise

Locations

Country Name City State
Canada Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS Sherbrooke Quebec

Sponsors (1)

Lead Sponsor Collaborator
Université de Sherbrooke

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) 5 days
Secondary 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) 5 days
Secondary 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) 5 days
Secondary 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) 5 days
Secondary 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) 5 days
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