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Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants (Opti-MCT)

Primary Purpose

Ketonemia

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
No MCT intake with breakfast, no lunch
No MCT intake with lunch, no breakfast
10g of Betaquik
10g of Betaquik with low-carbs breakfast
20g of Betaquik
10g of Betaquik with lunch, no breakfast
Sponsored by
Université de Sherbrooke
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Ketonemia focused on measuring Ketones, Medium Chain Triglycerides, Glucose, Insulin, Free fatty acids

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 10 health young (20-40 y old) and 10 health older (> 60 y old) participants
  • Men and women

Exclusion Criteria:

  • smoking
  • diabetes (fasting glucose >7.0 mmol/l and glycated hemoglobin >6.9%)
  • strenuous aerobic exercise more than three times a week
  • untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function
  • under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)

Sites / Locations

  • Rearsh Centre on Aging

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

MCT intake in young participants

MCT intake in older participants

Arm Description

Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants. Interventions: No MCT intake with breakfast, no lunch (i.e. CTL) No MCT intake with lunch, no breakfast (i.e CTL inverted) 10g of Betaquik with breakfast, no lunch (i.e BQ10) 20g of Betaquik with breakfast, no lunch (i.e BQ20) 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)

Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants. Interventions: No MCT intake with breakfast, no lunch (i.e. CTL) No MCT intake with lunch, no breakfast (i.e CTL inverted) 10g of Betaquik with breakfast, no lunch (i.e BQ10) 20g of Betaquik with breakfast, no lunch (i.e BQ20) 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)

Outcomes

Primary Outcome Measures

Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)
To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.

Secondary Outcome Measures

Concentration of plasma glucose
To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Concentration of plasma insulin
To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Concentration of plasma free fatty acids
To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.

Full Information

First Posted
February 1, 2019
Last Updated
March 24, 2020
Sponsor
Université de Sherbrooke
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1. Study Identification

Unique Protocol Identification Number
NCT03830268
Brief Title
Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants
Acronym
Opti-MCT
Official Title
Optimisation of Acute Medium Chain Triglycerides Intake Characteristics on Different Plasma Metabolites in Young and Older Participants
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 2, 2017 (Actual)
Primary Completion Date
June 25, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Université de Sherbrooke

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Compare plasma metabolites following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young and older participants.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ketonemia
Keywords
Ketones, Medium Chain Triglycerides, Glucose, Insulin, Free fatty acids

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MCT intake in young participants
Arm Type
Experimental
Arm Description
Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants. Interventions: No MCT intake with breakfast, no lunch (i.e. CTL) No MCT intake with lunch, no breakfast (i.e CTL inverted) 10g of Betaquik with breakfast, no lunch (i.e BQ10) 20g of Betaquik with breakfast, no lunch (i.e BQ20) 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)
Arm Title
MCT intake in older participants
Arm Type
Experimental
Arm Description
Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants. Interventions: No MCT intake with breakfast, no lunch (i.e. CTL) No MCT intake with lunch, no breakfast (i.e CTL inverted) 10g of Betaquik with breakfast, no lunch (i.e BQ10) 20g of Betaquik with breakfast, no lunch (i.e BQ20) 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)
Intervention Type
Dietary Supplement
Intervention Name(s)
No MCT intake with breakfast, no lunch
Other Intervention Name(s)
CTL
Intervention Description
Water given with a regular standardize breakfast and water given at noon without lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
No MCT intake with lunch, no breakfast
Other Intervention Name(s)
CTL inverted
Intervention Description
Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
10g of Betaquik
Other Intervention Name(s)
BQ10
Intervention Description
BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
10g of Betaquik with low-carbs breakfast
Other Intervention Name(s)
BQ10LC
Intervention Description
BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
20g of Betaquik
Other Intervention Name(s)
BQ20
Intervention Description
BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.
Intervention Type
Dietary Supplement
Intervention Name(s)
10g of Betaquik with lunch, no breakfast
Other Intervention Name(s)
BQ10 inverted
Intervention Description
BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.
Primary Outcome Measure Information:
Title
Concentration of plasma ketones (acetoacetate and B-hydroxybutyrate)
Description
To compare acute ketonemia following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
Concentration of plasma glucose
Description
To compare acute glucose following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Time Frame
8 hours
Title
Concentration of plasma insulin
Description
To compare acute insulin following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Time Frame
8 hours
Title
Concentration of plasma free fatty acids
Description
To compare acute free fatty acids following different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol.
Time Frame
8 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 10 health young (20-40 y old) and 10 health older (> 60 y old) participants Men and women Exclusion Criteria: smoking diabetes (fasting glucose >7.0 mmol/l and glycated hemoglobin >6.9%) strenuous aerobic exercise more than three times a week untreated hypertension, dyslipidemia, and abnormal renal, liver, heart or thyroid function under medication known to affect triglycerides and carbohydrates metabolism (i.e. diuretics, beta-blockers, steroids, insulin sensitizing)
Facility Information:
Facility Name
Rearsh Centre on Aging
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H4C4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26766547
Citation
Cunnane SC, Courchesne-Loyer A, St-Pierre V, Vandenberghe C, Pierotti T, Fortier M, Croteau E, Castellano CA. Can ketones compensate for deteriorating brain glucose uptake during aging? Implications for the risk and treatment of Alzheimer's disease. Ann N Y Acad Sci. 2016 Mar;1367(1):12-20. doi: 10.1111/nyas.12999. Epub 2016 Jan 14.
Results Reference
background
PubMed Identifier
28709938
Citation
Croteau E, Castellano CA, Fortier M, Bocti C, Fulop T, Paquet N, Cunnane SC. A cross-sectional comparison of brain glucose and ketone metabolism in cognitively healthy older adults, mild cognitive impairment and early Alzheimer's disease. Exp Gerontol. 2018 Jul 1;107:18-26. doi: 10.1016/j.exger.2017.07.004. Epub 2017 Jul 12.
Results Reference
background
PubMed Identifier
27629100
Citation
Courchesne-Loyer A, Croteau E, Castellano CA, St-Pierre V, Hennebelle M, Cunnane SC. Inverse relationship between brain glucose and ketone metabolism in adults during short-term moderate dietary ketosis: A dual tracer quantitative positron emission tomography study. J Cereb Blood Flow Metab. 2017 Jul;37(7):2485-2493. doi: 10.1177/0271678X16669366. Epub 2016 Jan 1.
Results Reference
background
PubMed Identifier
23274095
Citation
Courchesne-Loyer A, Fortier M, Tremblay-Mercier J, Chouinard-Watkins R, Roy M, Nugent S, Castellano CA, Cunnane SC. Stimulation of mild, sustained ketonemia by medium-chain triacylglycerols in healthy humans: estimated potential contribution to brain energy metabolism. Nutrition. 2013 Apr;29(4):635-40. doi: 10.1016/j.nut.2012.09.009. Epub 2012 Dec 28.
Results Reference
background
PubMed Identifier
25147107
Citation
Castellano CA, Nugent S, Paquet N, Tremblay S, Bocti C, Lacombe G, Imbeault H, Turcotte E, Fulop T, Cunnane SC. Lower brain 18F-fluorodeoxyglucose uptake but normal 11C-acetoacetate metabolism in mild Alzheimer's disease dementia. J Alzheimers Dis. 2015;43(4):1343-53. doi: 10.3233/JAD-141074.
Results Reference
background

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Acute Medium Chain Triglycerides (MCT) Intake in Young and Older Participants

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