Prediabetic State Clinical Trial
— MCT+AEOfficial title:
Stimulating the Production of Ketones Through the Combined Use of Aerobic Exercise (AE) and Dietary a Medium Chain Triglycerides (MCT) Supplement
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 |
Verified date | March 2020 |
Source | Université de Sherbrooke |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec |
Lead Sponsor | Collaborator |
---|---|
Université de Sherbrooke |
Canada,
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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