Brain energy activation with ketones to prevent alzheimer's disease
Sponsor(s) :
Université de Sherbrooke
Recruiment : open
Participating centers
1
0
Last modification : 2025-06-02
STUDY DESCRIPTION
Study 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.
Source : Import from center
RECRUITMENT
Participant profile
Age limits
minimum: 55 years old
maximum: 80 years old
Participants gender(s)
ALL
Source : Import from center
Medical condition (targeted specialty)
Research domain
Data not available
Selection criterias
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.
Cohorts
Name
Medical condition
Treatment
Recruitment status
Active group
Participants will be on the active intervention for 6 months
Data not available
Unknown
Placebo Group
Participants will be on the placebo intervention for 6 months
Data not available
Unknown
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.
Data not available
Unknown
Active group
Recruitment status
unknown
Participants will be on the active intervention for 6 months
Placebo Group
Recruitment status
unknown
Participants will be on the placebo intervention for 6 months
Open phase on active product
Recruitment status
unknown
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.
* 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.
Source : Import from center
Cohorts
Proposed Therapy or Intervention
Cohorts
Name
Medical condition
Treatment
Recruitment status
Active group
Participants will be on the active intervention for 6 months
Data not available
Unknown
Placebo Group
Participants will be on the placebo intervention for 6 months
Data not available
Unknown
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.
Data not available
Unknown
Active group
Recruitment status
unknown
Participants will be on the active intervention for 6 months
Placebo Group
Recruitment status
unknown
Participants will be on the placebo intervention for 6 months
Open phase on active product
Recruitment status
unknown
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.
Current data since :
June 02, 2025 20:00
Study's description
Study description
Study 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.
Source : Import from center
Locations
Locations
Participating centers
1
centers
CENTRE HOSPITALIER UNIVERSITAIRE DE SHERBROOKE
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