BRain Energy Activation With Ketones to Prevent Alzheimer... | NCT04466735

Studies
BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

NCT04466735

Sponsor

Université de Sherbrooke

Status

Completed

Last Update Posted

Jun 3, 2025Actual

Enrollment

65Actual

Phase

Not Applicable

Conditions

Interventions

Active group
Placebo group

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 15, 2020Actual

Primary Completion Date

Dec 12, 2024Actual

Completion Date

Mar 10, 2025Actual

First Submitted Date

Jul 7, 2020

First Submission Date that Met QC Criteria

Jul 9, 2020

First Posted Date

Jul 10, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2025

Last Update Posted Date

Jun 3, 2025Actual

Name	Class
Alzheimer's Association	OTHER
Nestle Health Science	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

A six month randomized controlled intervention with an exogenous ketone salt (EKS) supplement in mild cognitive impairment. Participants will receive 15 g of the supplement twice daily (equivalent to 24 g/day of EKS). Outcomes: brain energy metabolism, cognition, plasma biomarkers, brain imaging (volumetric, functional, structural) and quality of life will be analyzed before and after the intervention.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

65Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Active group	Experimental	Participants will be on the active intervention for 6 months	Dietary Supplement: Active group
Placebo Group	Placebo Comparator	Participants will be on the placebo intervention for 6 months	Dietary Supplement: Placebo group
Open phase on active product	Active Comparator	At the end of the 6-month randomized controlled phase, participants will be unblinded and invited to continue on the active product for an additional 3 months.	Dietary Supplement: Active group

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Active group	Dietary Supplement	2 x 12 g of EKS/day	Active group Open phase on active product

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Acetoacetate brain uptake	CMRacac measured by PET Scan	6 months
Glucose brain uptake	CMRgluc measured by PET Scan	6 months

Secondary Outcomes

Measure	Description	Time Frame
Cognition		0-3-6-9 months
Plasma biomarkers	glucose, fatty acids, ketones	9 months
Structural and functional brain measures

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

The participant must answer Yes to the question ''Do you think your memory is not as good as it was?''
Have a MoCA Score between 20/30 and 26/30
Have a QAF score of less than 9/30
Understand, read and talk French
Having good visual and hearing acuity

Exclusion Criteria:

Major cognitive decline or neurodegenerative disease.
Already consuming a daily medium chain triglyceride or ketone supplement.
Soy, milk, gluten or allergy to the study product
Controlled or uncontrolled diabetes
Uncontrolled chronic disease
Vitamin B12 deficit
Clinical anomaly in the blood chemistry profile
QSP-9 score over 19/27
Taking an anti-cholinergic drugs
Recent change in medication
Active cancer in the last 2 years
General anesthesia in the last 6 months
history of alcohol abuse or dependence in the last 2 years
Participation in other interventional or PET research project
Unable to undergo an MRI or PET scan
History of kidney stones or hypercalcemia
History of cardiovascular events or insufficiency
Renal failure and / or creatinine <58 umol or> 110 umol for men and <46 umol or> 92 umol for women or if the GFR (glomerular filtration rate) <60 ml / min / 1.73 m2
Chronic disease of the digestive system or intestinal malabsorption (celiac disease, chronic pancreatitis, Crohn's disease, etc.)
Body mass index <20 or voluntary weight loss of more than 5% in the last 6 months.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided