Clinical Trials Logo

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
See also
  Status Clinical Trial Phase
Completed NCT05424107 - A Mediterranean Intervention on Prediabetic Children N/A
Recruiting NCT02681887 - Effect of Melatonin on Cardiometabolic Risk- FULL Phase 3
Completed NCT04088461 - Effect of Linagliptin + Metformin on Patients Who do Not Achieve Normoglucemia With Metformine Phase 4
Recruiting NCT02561377 - Effect of Resistance Training on Metabolic Control and Outcome in Prediabetes (NMR-based Metabonomics) N/A
Completed NCT02551640 - Improving Physical Activity Through a mHealth Intervention in Cardio-metabolic Risk Patients N/A
Completed NCT02459691 - Culturally-adapted Diabetes Prevention Lifestyle Intervention for Latinos (E-LITE Latinos) N/A
Completed NCT01479933 - Glucose Metabolism Effects of Vitamin D Supplementation in Prediabetes N/A
Completed NCT01671293 - Multicomponent Telecare Model for Supporting Prediabetes Patients N/A
Completed NCT00960973 - The Effect of Vitamin K Supplementation on Glucose Metabolism Phase 4
Completed NCT00455325 - Chloroquine to Treat People With Metabolic Syndrome Aim2 (ARCH-MS) Phase 2
Recruiting NCT05123963 - Restoring 24-hour Substrate Rhythmicity to Improve Glycemic Control by Timing of Lifestyle Factors N/A
Recruiting NCT05340868 - Genetics of the Acute Response to Oral Semaglutide N/A
Recruiting NCT04984421 - IMplementation of the Family Support PRogramme A Healthy School Start to Prevent OVErweight and Obesity (IMPROVE) N/A
Recruiting NCT04134650 - Effect of Low Dose Combination of Linagliptin + Metformin to Prevent Diabetes Phase 3
Recruiting NCT04131582 - Effect of Empagliflozin + Linagliptin + Metformin + Lifestyle in Patients With Prediabetes Phase 3
Recruiting NCT05347030 - Acupuncture for Impaired Glucose Tolerance in Overweight/Obese Population N/A
Completed NCT04074148 - Effectiveness of Diabetes Prevention Education Program on Diabetes Prevention Among Prediabetes Population in Nepal N/A
Recruiting NCT05050266 - Enhancing Mental and Physical Health of Women Veterans N/A
Completed NCT02684565 - Effects of Branch Chain Amino Acids on Glucose Tolerance in Obese Pre-Diabetic Subjects N/A
Completed NCT01956929 - Metformin's Effect on Glucagon-induced Glucose Production and Protein Metabolism. Phase 1