Brain Energy and Aging With Triheptanoin: The BEAT7 Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Global Change in Brain Glucose Uptake
研究概览
简要总结
BEAT7-001 is a single group study (supplementation). Using a multi-modal brain imaging portfolio, this study will assess whether brain energy metabolism (glucose and ketones), structure or functional connectivity change in older people with frontal glucose hypometabolism after 28 days on an oral dose of 1 g/kg/day of triheptanoin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women ≥65 years old;
- •Score ≥26/30 on the Montreal Cognitive Assessment; -≥10% lower brain glucose uptake in the frontal cortex as determined by PET imaging.
排除标准
- •Score <26/30 on the Montreal Cognitive Assessment;
- •Medications likely to affect the primary cognitive outcome;
- •Medical or psychiatric conditions that could interfere with study participation (Peterson et al. 2005);
- •Fasting plasma glucose ≥7.0 mM (to avoid recruiting diabetics or pre-diabetics, both of which are risk factors for cognitive impairment in older persons (Mortimer et al. 2010) and also inhibit ketogenesis (Fukao et al. 2004);
- •Clinically-significant gastro-intestinal disease/conditions;
- •Clinically-significant liver disease/dysfunction : ALT ≥37 UI/L, AST ≥36 UI/L, Total bilirubin ≥26 μmol/L;
- •Clinically-significant renal disease/dysfunction : creatinine ≥92 μmol/L, glomerular filtration rate <60 ml/min/1.73 m2 or >90 ml/min/1.73 m2;
- •Clinically-significant cardiac disease/conditions;
- •Clinically-significant abnormal coagulation laboratory results or coagulation disorders at screening;
- •Poorly controlled dyslipidemia (total cholesterol ≥6.2 mmol/L or triglycerides ≥2.20 mmol/L)
- •Hypertension: ≥140/90 mmHg;
- •Substance abuse;
- •Already on MCT supplementation;
- •Visual or hearing impairment impeding comprehension;
- •Non-French speaking;
- •Any condition with life expectancy less than 5 years;
- •Institutionalized or intending to move out of area within 1 year;
- •Participation in other intervention trials.
研究组 & 干预措施
Triheptanoin
Participant will undergo POST Triheptanoin suppementation 1g/kg body weight for 28 days (dose gradually increased each week, starting at, 0.25, 0.5, 0.75 and then 1 g) separated in 4 doses (with eah meal and before night) after a control PRE supplementation imaging protocol.
干预措施: POST Triheptanoin (Drug)
结局指标
主要结局
Global Change in Brain Glucose Uptake
时间窗: 28±2 days
Global change (average of cortex) in brain glucose uptake as measured by 18F-FDG PET scans PRE vs POST 28±2 days of supplementation
Global Change in Brain Ketone Uptake
时间窗: 28±2 days
Global change in brain ketone uptake as measured by 11C-acetoacetate PET scans
次要结局
- Change in Brain Volumes(28±2 days)
- Change in Cerebral Blood Flow(28±2 days)