BRain Energy Activation With Ketones to Prevent Alzheimer's Disease
NCT ID: NCT04466735
Last Updated: 2025-06-03
Study Results
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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COMPLETED
NA
65 participants
INTERVENTIONAL
2020-10-15
2025-03-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Active group
Participants will be on the active intervention for 6 months
Active group
2 x 12 g of EKS/day
Placebo Group
Participants will be on the placebo intervention for 6 months
Placebo group
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.
Active group
2 x 12 g of EKS/day
Interventions
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Active group
2 x 12 g of EKS/day
Placebo group
Isocaloric placebo supplement with similar salt load but no EKS
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
55 Years
80 Years
ALL
Yes
Sponsors
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Alzheimer's Association
OTHER
Nestle Health Science
INDUSTRY
Université de Sherbrooke
OTHER
Responsible Party
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Locations
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Rearsh Centre on Aging
Sherbrooke, Quebec, Canada
Countries
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Other Identifiers
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2020-3448
Identifier Type: -
Identifier Source: org_study_id
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