Effect of Acute Cocoa Flavanol Intake on the BOLD Response and Cognitive Function in Patients With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 主要终点
- cognitive function
研究概览
简要总结
Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •non-smoking T1D patients or matched healthy controls
- •having diabetes for more than 1 year
- •males and females older than 18 years
- •stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
- •adequate visual and auditory acuity to allow neuropsychological testing.
排除标准
- •participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
- •history in the past 2 years of epileptic seizures or any major psychiatric disorder
- •history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
- •significant history of alcoholism or drug abuse
- •unstable cardiac, renal, lung, liver, or other severe chronic disease
- •hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure <100 mmHg)
- •pacemaker or other medical metal devices that precludes performing MRI,
- •chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
- •macrovascular complications
- •retinopathy, nephropathy or neuropathy (microvascular complications)
研究组 & 干预措施
high cocoa flavanol drink
high cocoa flavanol drink (900 mg cocoa flavanol dissolved in 300 ml skimmed milk) 2h pre-fMRI
干预措施: cocoa flavanol supplementation (Dietary Supplement)
low cocoa flavanol drink
low cocoa flavanol drink (30 mg cocoa flavanol dissolved in 300 ml skimmed milk), matched for theobromine, caffeine and macronutrients with the high cocoa flavanol drink 2h-pre fMRI
干预措施: cocoa flavanol supplementation (Dietary Supplement)
结局指标
主要结局
cognitive function
时间窗: 5 min
reaction time (milliseconds) on the flanker task
BOLD fmri response
时间窗: 5 min
blood oxygenation level dependent response during flanker test
次要结局
未报告次要终点
研究者
Romain Meeusen
Prof.
Vrije Universiteit Brussel