Trial of Pistachio Consumption on Cognition, Cardiometabolic Risk Factors, and Life Satisfaction in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- Mobile Toolbox
研究概览
简要总结
The goal of this study is to evaluate whether a pistachio-enriched diet leads to changes in cognitive function, cardiometabolic risk factors, and life satisfaction in older adults over a 6-month period.
详细描述
In this remote-based, parallel-arm RCT, the investigators will recruit participants from the recently completed COcoa Supplement and Multivitamin Outcomes Study (COSMOS) trial cohort. Eligible COSMOS participants will be invited to participate in the proposed RCT, screened to verify eligibility and willingness to participate, and asked to provide informed consent. Eligible and willing participants will be enrolled and randomized on a rolling basis. Risk factors and Outcome assessments will be conducted at baseline, 3 months and 6 months via the MyCap Mobile Toolbox application, REDCap questionnaires (for life satisfaction, dietary, and other phenotypic assessments), or at a local Quest Diagnostics (for biospecimen collection and return to our biorepository).
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 平行分组
- 主要目的
- 预防
- 盲法
- 开放（无盲法）
盲法说明
Outcome assessments will be blinded.
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- Active participant in COSMOS
- Current age 65 to 80 years
- Does not reside in the states of Arizona, Hawaii, or Wyoming (since Quest Diagnostics does not have locations in these states)
排除标准
- Tree nut allergy
- Current intake of pistachios, peanuts, walnuts, or other nuts >1 serving/week
- Diagnosis of Alzheimer's disease or any other type of dementia
- Diagnosis of cancer or CVD (MI, stroke, CABG, PTCA, or stent) within last 12 months
- Changes in the dose or number of anti-hypertensive, lipid-lowering, or diabetic medications over the past 3 months prior to randomization
- Does not own a smartphone or tablet
- Unable or unwilling to abstain from pistachio intake for 6 months
- Unable or unwilling to limit nut consumption to ≤1 serving/week for 6 months
- Unable or unwilling to complete online questionnaires and cognitive assessments
- Unable or unwilling to travel to a local Quest site for biospecimen collection
- Unable or unwilling to provide consent to participate in the trial
- Failure to complete the baseline Life Satisfaction Questionnaire
- Failure to complete the baseline cognitive assessments
- Failure to complete the baseline biospecimen collection
研究组 & 干预措施
Pistachio-enriched diet
1 packet/day of approximately 1.25 oz (35 g) of dry roasted, unsalted, shelled pistachio kernels
干预措施: Pistachio-enriched diet (Other)
Usual diet
Usual diet (while abstaining from pistachio consumption and limiting other nut consumption to ≤1 serving/week)
干预措施: Usual diet (Other)
结局指标
主要结局
Mobile Toolbox
时间窗: Baseline and 6 months
The investigators will assess 6-month changes in the Mobile Toolbox (MTB) fluid cognition composite (FCC) score via MyCap. Participants will be instructed to install the MyCap app on their personal smartphones to complete the assessments. The FCC score considers the following domains (tests): associative memory (Face and Names), episodic memory (Arranging Pictures), working memory (Sequences), processing speed (Number-Symbol Match), and executive function (Arrow Matching for inhibitory control, Shape-Color Sorting for cognitive flexibility). The FCC score will be calculated by standardizing scores for each MTB test using means and standard deviations (SD) across the entire sample and averaging z-scores across the six tests (mean=0; SD=1). Higher FCC scores will indicate better cognitive function.
次要结局
- Faces and Names(Baseline and 6 months)
- Body weight(Baseline and 6 months)
- Arranging Pictures(Baseline and 6 months)
- Sequences(Baseline and 6 months)
- Number-Symbol Match(Baseline and 6 months)
- Waist circumference(Baseline and 6 months)
- Shape-Color Sorting(Baseline and 6 months)
- Arrow Matching(Baseline and 6 months)
- Blood pressure(Baseline and 6 months)
- Insulin-like growth factor-1(Baseline and 6 months)
- Interleukin-6(Baseline and 6 months)
- Fasting blood glucose(Baseline and 6 months)
- Life Satisfaction for the Third Age-Short Form(Baseline and 6 months)
- Lipid profile(Baseline and 6 months)
研究者
Howard D. Sesso, ScD, MPH
Associate Epidemiologist
Brigham and Women's Hospital
研究点 (1)
标识符
- NCT 编号
- NCT06992544
- 其他研究编号
- 2024P002479
日期
- 首次提交
- (去年)
- 首次发布
- (去年)
- 主要完成日期
- (下个月)
- 研究完成日期
- (下个月)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- UNDECIDED
- 是否有结果
- 否