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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy women | Experimental | 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:
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| Women with prediabetes | Experimental | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MCT | Dietary Supplement | A 5 day consecutive MCT intake of 30 g/day. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen Cunnane, PhD | Research Centre on Aging, CIUSSS de l'Estrie-CHUS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS | Sherbrooke | Quebec | J1H 4C4 | Canada |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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 |
| FG001 | 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:
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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Control (5 Days) |
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| MCT (5 Days) |
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| AE (1 Day) |
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| MCT + AE (5 Days) |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Mean | Standard Deviation | (µmol/h)/L | 5 days |
|
2 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pr. Stephen Cunnane | Research Centre on Aging | 819-780-2220 | 45670 | stephen.cunnane@usherbrooke.ca |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 1, 2016 | Jan 30, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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| MCT+ aerobic exercise | Dietary Supplement | 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. |
|
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| Aerobic exercise | Dietary Supplement | A single period of 30 minutes of aerobic exercise (70% to 80% HRR). |
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| Control day | Dietary Supplement | No MCT or aerobic exercise |
|
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| 5 days |
| 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 |
| 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 |
| 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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| BG001 | 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:
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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body mass index | Mean | Standard Deviation | kg/m2 |
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| Total body fat | Mean | Standard Deviation | % of body fat |
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| Plasma glucose | Mean | Standard Deviation | mmol/L |
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| Glycated hemoglobin | Mean | Standard Deviation | % of glycated hemoglobin |
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| Ketones | Mean | Standard Deviation | µmol/L |
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| Triglycerides | Mean | Standard Deviation | mmol/L |
|
| Free Fatty acids | Mean | Standard Deviation | mmol/L |
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| Insulin | Mean | Standard Deviation | pmol/L |
|
| OG001 | 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:
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 |
|
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| 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) | Posted | Mean | Standard Deviation | (mmol*h)/L | 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) | Posted | Mean | Standard Deviation | (mmol*h)/L | 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) | Posted | Mean | Standard Deviation | (mmol*h)/L | 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) | Posted | Mean | Standard Deviation | (nmol*h)/L | 5 days |
|
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| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | 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:
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 | 0 | 9 | 0 | 9 | 0 | 9 |
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| D004700 | Endocrine System Diseases |
| AE: AUC glucose |
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| MCT+AE: AUC glucose |
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| AE: AUC triglycerides |
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| MCT+AE: AUC triglycerides |
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| AE: AUC Free fatty acids |
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| MCT+AE: AUC Free fatty acids |
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| AE: AUC Insulin |
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| MCT+AE: AUC Insulin |
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