BRain Energy Activation With Ketones to Prevent Alzheimer's Disease

NCT ID: NCT04466735

Last Updated: 2025-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-15

Study Completion Date

2025-03-10

Brief Summary

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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

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Conditions

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MCI

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial. First phase :Two parallel groups, one placebo, one active Second phase : All participants will be invited to take part in an open phase on the active product only.
Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
Investigators, participants and outcome assessors will be fully blinded.

Study Groups

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Active group

Participants will be on the active intervention for 6 months

Group Type EXPERIMENTAL

Active group

Intervention Type DIETARY_SUPPLEMENT

2 x 12 g of EKS/day

Placebo Group

Participants will be on the placebo intervention for 6 months

Group Type PLACEBO_COMPARATOR

Placebo group

Intervention Type DIETARY_SUPPLEMENT

Isocaloric placebo supplement with similar salt load but no EKS

Open phase on active product

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.

Group Type ACTIVE_COMPARATOR

Active group

Intervention Type DIETARY_SUPPLEMENT

2 x 12 g of EKS/day

Interventions

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Active group

2 x 12 g of EKS/day

Intervention Type DIETARY_SUPPLEMENT

Placebo group

Isocaloric placebo supplement with similar salt load but no EKS

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Alzheimer's Association

OTHER

Sponsor Role collaborator

Nestle Health Science

INDUSTRY

Sponsor Role collaborator

Université de Sherbrooke

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Rearsh Centre on Aging

Sherbrooke, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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2020-3448

Identifier Type: -

Identifier Source: org_study_id

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