6 Month Randomized Controlled Trial With D-beta-hydroxybutyrate in Mild Cognitive Impairment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Acetoacetate brain uptake
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Investigators, participants and outcome assessors will be fully blinded.
入排标准
- 年龄范围
- 55 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Active group
Participants will be on the active intervention for 6 months
干预措施: Active group (Dietary Supplement)
Placebo Group
Participants will be on the placebo intervention for 6 months
干预措施: Placebo group (Dietary Supplement)
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.
干预措施: Active group (Dietary Supplement)
结局指标
主要结局
Acetoacetate brain uptake
时间窗: 6 months
CMRacac measured by PET Scan
Glucose brain uptake
时间窗: 6 months
CMRgluc measured by PET Scan
次要结局
- Plasma biomarkers(9 months)
- Cognition(0-3-6-9 months)
- Structural and functional brain measures(6 months)