Prediabetic State
Conditions
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.
Interventions
DIETARY_SUPPLEMENTMCT
A 5 day consecutive MCT intake of 30 g/day.
DIETARY_SUPPLEMENTMCT+ 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.
DIETARY_SUPPLEMENTAerobic exercise
A single period of 30 minutes of aerobic exercise (70% to 80% HRR).
DIETARY_SUPPLEMENTControl day
No MCT or aerobic exercise
Sponsors
Université de Sherbrooke
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Ketone Concentrations | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Glucose Concentrations | 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) |
| Plasma Triglyceride Concentrations | 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) |
| Plasma Free Fatty Acid Concentrations | 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) |
| Plasma Insulin Concentrations | 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) |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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 | 10 |
| 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.
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 | 9 |
| Total | 19 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| AE (1 Day) | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Healthy Women | Women With Prediabetes | Total |
|---|---|---|---|
| Age, Continuous | 67 years STANDARD_DEVIATION 4 | 68 years STANDARD_DEVIATION 5 | 68 years STANDARD_DEVIATION 4 |
| Body mass index | 27 kg/m2 STANDARD_DEVIATION 3 | 28 kg/m2 STANDARD_DEVIATION 4 | 27 kg/m2 STANDARD_DEVIATION 4 |
| Free Fatty acids | 0.8 mmol/L STANDARD_DEVIATION 0.3 | 0.7 mmol/L STANDARD_DEVIATION 0.3 | 0.75 mmol/L STANDARD_DEVIATION 0.3 |
| Glycated hemoglobin | 5.7 % of glycated hemoglobin STANDARD_DEVIATION 0.2 | 6.1 % of glycated hemoglobin STANDARD_DEVIATION 0.2 | 5.9 % of glycated hemoglobin STANDARD_DEVIATION 0.2 |
| Insulin | 64 pmol/L STANDARD_DEVIATION 11 | 65 pmol/L STANDARD_DEVIATION 32 | 64.5 pmol/L STANDARD_DEVIATION 22 |
| Ketones | 153 µmol/L STANDARD_DEVIATION 94 | 116 µmol/L STANDARD_DEVIATION 71 | 135 µmol/L STANDARD_DEVIATION 83 |
| Plasma glucose | 5.4 mmol/L STANDARD_DEVIATION 0.1 | 6.1 mmol/L STANDARD_DEVIATION 0.4 | 5.8 mmol/L STANDARD_DEVIATION 0.3 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 10 participants | 9 participants | 19 participants |
| Sex: Female, Male Female | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Total body fat | 43 % of body fat STANDARD_DEVIATION 6 | 40 % of body fat STANDARD_DEVIATION 4 | 42 % of body fat STANDARD_DEVIATION 5 |
| Triglycerides | 1.5 mmol/L STANDARD_DEVIATION 0.4 | 1.6 mmol/L STANDARD_DEVIATION 0.8 | 1.55 mmol/L STANDARD_DEVIATION 0.6 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 9 |
| other Total, other adverse events | 0 / 10 | 0 / 9 |
| serious Total, serious adverse events | 0 / 10 | 0 / 9 |
Outcome results
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)
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Women | Plasma Ketone Concentrations | CTL: AUC ketone | -52 (µmol/h)/L | Standard Deviation 117 |
| Healthy Women | Plasma Ketone Concentrations | AE: AUC ketone | 122 (µmol/h)/L | Standard Deviation 146 |
| Healthy Women | Plasma Ketone Concentrations | MCT: AUC ketone | 493 (µmol/h)/L | Standard Deviation 243 |
| Healthy Women | Plasma Ketone Concentrations | MCT+AE: AUC ketone | 835 (µmol/h)/L | Standard Deviation 444 |
| Women With Prediabetes | Plasma Ketone Concentrations | MCT+AE: AUC ketone | 663 (µmol/h)/L | Standard Deviation 417 |
| Women With Prediabetes | Plasma Ketone Concentrations | CTL: AUC ketone | 12 (µmol/h)/L | Standard Deviation 96 |
| Women With Prediabetes | Plasma Ketone Concentrations | MCT: AUC ketone | 627 (µmol/h)/L | Standard Deviation 489 |
| Women With Prediabetes | Plasma Ketone Concentrations | AE: AUC ketone | 23 (µmol/h)/L | Standard Deviation 74 |
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)
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Women | Plasma Free Fatty Acid Concentrations | CTL: AUC Free fatty acids | 1.3 (mmol*h)/L | Standard Deviation 0.3 |
| Healthy Women | Plasma Free Fatty Acid Concentrations | MCT: AUC Free fatty acids | 1.3 (mmol*h)/L | Standard Deviation 0.2 |
| Healthy Women | Plasma Free Fatty Acid Concentrations | AE: AUC Free fatty acids | 1.3 (mmol*h)/L | Standard Deviation 0.2 |
| Healthy Women | Plasma Free Fatty Acid Concentrations | MCT+AE: AUC Free fatty acids | 1.4 (mmol*h)/L | Standard Deviation 0.6 |
| Women With Prediabetes | Plasma Free Fatty Acid Concentrations | MCT+AE: AUC Free fatty acids | 1.6 (mmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Free Fatty Acid Concentrations | CTL: AUC Free fatty acids | 1.3 (mmol*h)/L | Standard Deviation 0.6 |
| Women With Prediabetes | Plasma Free Fatty Acid Concentrations | AE: AUC Free fatty acids | 1.4 (mmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Free Fatty Acid Concentrations | MCT: AUC Free fatty acids | 1.5 (mmol*h)/L | Standard Deviation 0.4 |
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)
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Women | Plasma Glucose Concentrations | CTL: AUC glucose | 7.6 (mmol*h)/L | Standard Deviation 1.4 |
| Healthy Women | Plasma Glucose Concentrations | MCT: AUC glucose | 7.3 (mmol*h)/L | Standard Deviation 1.3 |
| Healthy Women | Plasma Glucose Concentrations | AE: AUC glucose | 7.6 (mmol*h)/L | Standard Deviation 1 |
| Healthy Women | Plasma Glucose Concentrations | MCT+AE: AUC glucose | 7.7 (mmol*h)/L | Standard Deviation 1.5 |
| Women With Prediabetes | Plasma Glucose Concentrations | MCT+AE: AUC glucose | 10.3 (mmol*h)/L | Standard Deviation 1.8 |
| Women With Prediabetes | Plasma Glucose Concentrations | CTL: AUC glucose | 11.0 (mmol*h)/L | Standard Deviation 2.8 |
| Women With Prediabetes | Plasma Glucose Concentrations | AE: AUC glucose | 10.4 (mmol*h)/L | Standard Deviation 3 |
| Women With Prediabetes | Plasma Glucose Concentrations | MCT: AUC glucose | 11.6 (mmol*h)/L | Standard Deviation 2.8 |
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)
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Women | Plasma Insulin Concentrations | CTL: AUC Insulin | 0.9 (nmol*h)/L | Standard Deviation 0.5 |
| Healthy Women | Plasma Insulin Concentrations | MCT: AUC Insulin | 0.8 (nmol*h)/L | Standard Deviation 0.3 |
| Healthy Women | Plasma Insulin Concentrations | AE: AUC Insulin | 0.8 (nmol*h)/L | Standard Deviation 0.2 |
| Healthy Women | Plasma Insulin Concentrations | MCT+AE: AUC Insulin | 0.7 (nmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Insulin Concentrations | MCT+AE: AUC Insulin | 0.6 (nmol*h)/L | Standard Deviation 0.2 |
| Women With Prediabetes | Plasma Insulin Concentrations | CTL: AUC Insulin | 0.8 (nmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Insulin Concentrations | AE: AUC Insulin | 0.7 (nmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Insulin Concentrations | MCT: AUC Insulin | 0.8 (nmol*h)/L | Standard Deviation 0.8 |
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)
Time frame: 5 days
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Healthy Women | Plasma Triglyceride Concentrations | CTL: AUC triglycerides | 3.6 (mmol*h)/L | Standard Deviation 0.6 |
| Healthy Women | Plasma Triglyceride Concentrations | MCT: AUC triglycerides | 3.9 (mmol*h)/L | Standard Deviation 0.4 |
| Healthy Women | Plasma Triglyceride Concentrations | AE: AUC triglycerides | 4.0 (mmol*h)/L | Standard Deviation 0.4 |
| Healthy Women | Plasma Triglyceride Concentrations | MCT+AE: AUC triglycerides | 3.9 (mmol*h)/L | Standard Deviation 0.6 |
| Women With Prediabetes | Plasma Triglyceride Concentrations | MCT+AE: AUC triglycerides | 3.5 (mmol*h)/L | Standard Deviation 0.8 |
| Women With Prediabetes | Plasma Triglyceride Concentrations | CTL: AUC triglycerides | 3.8 (mmol*h)/L | Standard Deviation 0.3 |
| Women With Prediabetes | Plasma Triglyceride Concentrations | AE: AUC triglycerides | 3.7 (mmol*h)/L | Standard Deviation 0.7 |
| Women With Prediabetes | Plasma Triglyceride Concentrations | MCT: AUC triglycerides | 3.5 (mmol*h)/L | Standard Deviation 0.5 |