Food Supplement Approach for Prevention of Age-associated Cognitive Decline in Older Adults With Obesity: the Nutrition for Brain and Body Health (BB-Health) Feasibility Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Cognitive function
研究概览
简要总结
The goal of the trial is to determine the feasibility of implementing a specific nutrition regimen used alone or in combination with a behavioral weight loss (WL) intervention on cognition and cerebral blood flow in older adults at risk of cognitive decline.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Masking occurs after randomization. Participants and investigators and outcome assessors are masked to the assignment to the nutritional supplement vs placebo. Investigators responsible for the weight loss intervention, and outcome assessors, are masked to the assignment to the behavioral weight loss intervention versus the wait-list control.
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Cognitive function
时间窗: Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization
Change in age-sensitive cognitive composite z-score from baseline, based on well-established standardized scores on 5 neuropsychological tests (Controlled Oral; Word Association Test, Digit Symbol Substitution Test; Stroop Interference Test; Trails Making Tests A and B)
次要结局
- Microvascular cerebral blood flow in fasting state(Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization)
- Microvascular cerebral blood flow in fed state(Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization)
- Macrovascular cerebral blood flow velocity in fed state(Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization)
- Macrovascular cerebral blood flow velocity in fasting state(Measure at baseline (pre-randomization), and 3, 6 and 12 months after randomization)