NCT02678390

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
2.6 years until next milestone

Results Posted

Study results publicly available

April 7, 2020

Completed
Last Updated

April 7, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

February 5, 2016

Results QC Date

January 31, 2019

Last Update Submit

March 24, 2020

Conditions

Prediabetic State

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Plasma Glucose Concentrations

    5 days

  • Plasma Triglyceride Concentrations

    5 days

  • Plasma Free Fatty Acid Concentrations

    5 days

  • Plasma Insulin Concentrations

    5 days

Study Arms (2)

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: 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.

Dietary Supplement: MCTDietary Supplement: MCT+ aerobic exerciseDietary Supplement: Aerobic exerciseDietary Supplement: Control day

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: 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.

Dietary Supplement: MCTDietary Supplement: MCT+ aerobic exerciseDietary Supplement: Aerobic exerciseDietary Supplement: Control day

Interventions

MCTDIETARY_SUPPLEMENT

A 5 day consecutive MCT intake of 30 g/day.

Healthy womenWomen with prediabetes
MCT+ aerobic exerciseDIETARY_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.

Also known as: MCT+AE
Healthy womenWomen with prediabetes
Aerobic exerciseDIETARY_SUPPLEMENT

A single period of 30 minutes of aerobic exercise (70% to 80% HRR).

Also known as: AE
Healthy womenWomen with prediabetes
Control dayDIETARY_SUPPLEMENT

No MCT or aerobic exercise

Also known as: CTL
Healthy womenWomen with prediabetes

Eligibility Criteria

Age60 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 %

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS

Sherbrooke, Quebec, J1H 4C4, Canada

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Pr. Stephen Cunnane
Organization
Research Centre on Aging
stephen.cunnane@usherbrooke.ca
819-780-2220

Study Officials

  • Stephen Cunnane, PhD

    Research Centre on Aging, CIUSSS de l'Estrie-CHUS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2016

First Posted

February 9, 2016

Study Start

September 1, 2015

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

April 7, 2020

Results First Posted

April 7, 2020

Record last verified: 2020-03

Locations

CA(1)