Using ketone supplements to improve brain energy and prevent Alzheimer's disease
6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
This study is testing whether a ketone supplement can help people with mild cognitive impairment improve their brain energy and overall quality of life.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 56 (estimated) |
| Ages | 55 Years to 80 Years |
| Sex | All |
| Sponsor | Université de Sherbrooke Academic / other |
| Locations | 1 site (Sherbrooke, Quebec) |
| Trial ID | NCT04466735 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of an exogenous ketone salt (EKS) supplement on individuals with mild cognitive impairment (MCI). Over six months, participants will be randomly assigned to receive either the EKS supplement or a placebo, with the aim of assessing changes in brain energy metabolism, cognitive function, plasma biomarkers, and quality of life. The study will utilize various methods, including brain imaging and cognitive assessments, to evaluate the outcomes before and after the intervention.
Who should consider this trial
Good fit: Ideal candidates are individuals experiencing mild cognitive impairment who believe their memory has declined.
Not a fit: Patients with major cognitive decline, neurodegenerative diseases, or those on certain medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance brain energy metabolism and potentially slow the progression of Alzheimer's disease in at-risk individuals.
How similar studies have performed: While the use of ketones for cognitive enhancement is a novel approach, similar studies have shown promising results in related areas.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Sherbrooke, Quebec
- Rearsh Centre on Aging — Sherbrooke, Quebec, Canada (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.