NCT03830268

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.

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 Jun 2017

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 2, 2017

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 25, 2019

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2.1 years

First QC Date

February 1, 2019

Last Update Submit

March 24, 2020

Conditions

Ketonemia

Keywords

KetonesMedium Chain TriglyceridesGlucoseInsulinFree fatty acids

Outcome Measures

Primary Outcomes (1)

  • 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.

    8 hours

Secondary Outcomes (3)

  • Concentration of plasma glucose

    8 hours

  • Concentration of plasma insulin

    8 hours

  • Concentration of plasma free fatty acids

    8 hours

Study Arms (2)

MCT intake in young participants

EXPERIMENTAL

Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in young participants. Interventions: 1. No MCT intake with breakfast, no lunch (i.e. CTL) 2. No MCT intake with lunch, no breakfast (i.e CTL inverted) 3. 10g of Betaquik with breakfast, no lunch (i.e BQ10) 4. 20g of Betaquik with breakfast, no lunch (i.e BQ20) 5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)

Dietary Supplement: No MCT intake with breakfast, no lunchDietary Supplement: No MCT intake with lunch, no breakfastDietary Supplement: 10g of BetaquikDietary Supplement: 10g of Betaquik with low-carbs breakfastDietary Supplement: 20g of BetaquikDietary Supplement: 10g of Betaquik with lunch, no breakfast

MCT intake in older participants

EXPERIMENTAL

Different conditions paired with a dietary MCT beverage over an 8-hour metabolic day protocol in older participants. Interventions: 1. No MCT intake with breakfast, no lunch (i.e. CTL) 2. No MCT intake with lunch, no breakfast (i.e CTL inverted) 3. 10g of Betaquik with breakfast, no lunch (i.e BQ10) 4. 20g of Betaquik with breakfast, no lunch (i.e BQ20) 5. 10g of Betaquik with low-carbs breakfast, no lunch (i.e BQ10LC) 6. 10g of Betaquik with lunch, no breakfast (i.e BQ10 inverted)

Dietary Supplement: 10g of Betaquik

Interventions

No MCT intake with breakfast, no lunchDIETARY_SUPPLEMENT

Water given with a regular standardize breakfast and water given at noon without lunch.

Also known as: CTL
MCT intake in young participants
No MCT intake with lunch, no breakfastDIETARY_SUPPLEMENT

Water given in the beginning of the metabolic study day without breakfast and water given at noon with a regular standardize lunch.

Also known as: CTL inverted
MCT intake in young participants
10g of BetaquikDIETARY_SUPPLEMENT

BQ10 given with a regular standardize breakfast and BQ10 given at noon without lunch.

Also known as: BQ10
MCT intake in older participantsMCT intake in young participants
10g of Betaquik with low-carbs breakfastDIETARY_SUPPLEMENT

BQ10 given with a low-carbs standardize breakfast and BQ10 given at noon without lunch.

Also known as: BQ10LC
MCT intake in young participants
20g of BetaquikDIETARY_SUPPLEMENT

BQ20 given with a regular standardize breakfast and BQ20 given at noon without lunch.

Also known as: BQ20
MCT intake in young participants
10g of Betaquik with lunch, no breakfastDIETARY_SUPPLEMENT

BQ10 given in the beginning of the metabolic study day without breakfast and BQ10 given at noon with a regular standardize lunch.

Also known as: BQ10 inverted
MCT intake in young participants

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rearsh Centre on Aging

Sherbrooke, Quebec, J1H4C4, Canada

Location

Related Publications (5)

  • 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.

    PMID: 26766547BACKGROUND

  • 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.

    PMID: 28709938BACKGROUND

  • 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.

    PMID: 27629100BACKGROUND

  • 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.

    PMID: 23274095BACKGROUND

  • 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.

    PMID: 25147107BACKGROUND

MeSH Terms

Conditions

KetosisInsulin Resistance

Interventions

BreakfastLunch

Condition Hierarchy (Ancestors)

AcidosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Intervention Hierarchy (Ancestors)

MealsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: 10 young and 10 older participants undergoing six separate but identical metabolic visits (interventions)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 5, 2019

Study Start

June 2, 2017

Primary Completion

June 25, 2019

Study Completion

June 25, 2019

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)