跳至主要内容
临床试验/NCT05992571
NCT05992571招募中不适用

The Impact of Acute Oral Ketone Monoester Supplementation on Resting-state Brain Connectivity in Adults With Memory Complaints

McMaster University2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年10月25日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
2
主要终点
Cerebral blood flow

研究概览

简要总结

People who report subjective memory complaints have a greater risk of developing dementia. Memory issues may be an early warning sign of dysfunctional cerebral glucose metabolism and cerebral blood flow. Interventions that can restore cerebral metabolism and enhance cerebral blood flow may protect against conversion to dementia. Exogenous ketone supplements have been shown rapidly improves brain network function in young adults. Further, infusion studies demonstrate that ketone bodies enhance cerebral blood flow in cognitively normal adults. Whether acute ketone monoester supplementation can improve brain function in adults with subjective memory complaints is currently unknown.

This study will investigate the effects of a single ketone monoester dose on resting-state functional connectivity in the default mode network and resting cerebral blood flow in adults with subjective memory complaints.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
55 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • between the ages of 55 and 70
  • presence of subjective memory complaints as determined by the Prospective- Retrospective Memory Questionnaire
  • cognitively normal, e.g. score ≥26 on the Montreal Cognitive Assessment

排除标准

  • Presence of obesity (body mass index > 30 kg/m^2)
  • Presence of known cardiovascular disease
  • Presence of type 2 diabetes
  • History of cardiovascular events requiring hospitalization in the past 3 years (e.g., heart attack, stroke)
  • History of concussion(s) with persistent symptoms
  • Currently following a ketogenic diet and/or taking ketone body supplements
  • Diagnosis of any form of Alzheimer's disease or dementia

结局指标

主要结局

Cerebral blood flow

时间窗: 90 minutes

Sum of blood flow in the internal carotid and vertebral arteries via phase contrast MRI in ml/min.

Brain network connectivity

时间窗: 90 minutes

Functional connectivity of the default mode network (DMN) is measured via functional MRI. Changes in BOLD signal in each region are determined by independent component analysis and then functional connectivity is measured as a Pearson correlation (r) between the neural regions comprising the DMN and transformed into a z score.

次要结局

  • Executive function(90 minutes)
  • Attention and working memory(90 minutes)
  • Working memory(90 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jeremy Walsh

Assistant Professor

McMaster University

研究点 (2)

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