Cranberry Polyphenols and Human Stress Resilience: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial Integrating Cognitive, Physiological, and Microbiome Adaptations Underlying Nutritional Neuroprotection and Multitasking Performance in Healthy Adults.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Cognitive task performance (serial subtraction accuracy)
研究概览
简要总结
This randomized, double-blind, placebo-controlled clinical trial evaluates whether 70 days of daily cranberry juice consumption improves cognitive performance and motor accuracy and reduces psychological and physiological stress responses during a motor-cognitive dual-task multitasking challenge in healthy adults aged 30-55 (Aim 1). It is hypothesized that chronic cranberry juice intake will enhance dual-task performance and attenuate stress reactivity (Hypothesis 1). It is further hypothesized that cranberry juice will mitigate multitasking-related fatigue, mood fluctuations, and cognitive impairment, accompanied by favorable changes in circulating stress biomarkers and stress-regulatory neurochemical pathways (Aim 2/Hypothesis 2). Finally, the study incorporates gut analysis to determine whether cranberry juice induces beneficial shifts in the gut microbiota and microbial metabolites (e.g., SCFAs) and whether these changes are associated with improved cognitive and stress-related outcomes, consistent with a microbiome-gut-brain axis mechanism (Aim 3/Hypothesis 3).
详细描述
Recruitment and Screening
Individuals who express interest will complete an initial study interest form. If preliminarily qualified, individuals will proceed to a screening process conducted via Qualtrics. Study staff will review responses to confirm eligibility and identify exclusions based on predefined criteria.
Study Design, Visits, and Timeline
This randomized, double-blind, placebo-controlled, parallel-design trial spans 13 weeks and includes three in-person visits: the consent visit (V1), the baseline visit (V2), and the final visit (V3).
Consent Visit (V1)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Study coordinator and staff are also blinded.
入排标准
- 年龄范围
- 30 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 110 pounds
- •Between 30 and 55 years
- •BMI between 18.9 and 29.9 kg/m²
- •A minimum education level of high school or above
排除标准
- •Heavy caffeine users (consuming more than 300 mg/day or more than two cups of coffee per day)
- •Alcohol consumption exceeding three drinks per week
- •A smoking history of 10 years or more, or current use of cannabis products
- •Uncontrolled hypertension
- •Clinically diagnosed illnesses such as diabetes, cardiovascular disease, neurological disorders, or mental health conditions
- •Participants currently taking prescribed anti-inflammatory medications, antibiotics, or antidepressants that may affect study outcomes, particularly those related to blood and fecal sample analysis
- •Individuals who regularly take vitamin or mineral supplements and are unwilling to discontinue them for the duration of the study will not qualify.
- •Participants must be willing to maintain their current daily routine and lifestyle, undergo body weight and height measurements, and notify study coordinators of any illnesses or significant adverse life events during the study period
- •Those with specific dietary restrictions that prevent them from consuming the standardized breakfast sandwich required in the study protocol
- •Participants must successfully complete the on-site multitasking task as a screening measure prior to signing consent.
- •Beck's Depression Inventory score of 21 or higher
- •Beck's Anxiety Inventory score of 21 or higher
- •A history of severe suicidal tendencies, or seasonal depression
- •Pregnancy and breastfeeding (Female participants must complete four pregnancy tests throughout the study and track their menstrual cycle. Those unwilling to comply with these requirements will not be eligible.)
- •Potential participants must not have taken any anti-inflammatory medications, antibiotics, or antidepressants within the past three months prior to the start of the study
- •Individuals who were previously enrolled in IRB#202300950 will be excluded due to the learning effect of cognitive tests, ensuring accurate data collection for this study
研究组 & 干预措施
Cranberry juice
Cranberry juice will be provided by Ocean Spray Company.
干预措施: Cranberry juice (Other)
Placebo cranberry juice
Placebo juice will be provided from Ocean Spray Company to match the appearance, taste, and calories of the cranberry beverage; it contains no active cranberry components.
干预措施: Placebo juice (Other)
结局指标
主要结局
Cognitive task performance (serial subtraction accuracy)
时间窗: Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).
Total number of correct subtractions during the multitasking cognitive task Measure Description: Counting backward aloud from a random number between 800-999 by 3, 7, and 17; performance scored as total correct subtractions across the task.
Cognitive task performance (serial subtraction errors)
时间窗: Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).
Outcome Measure: Total number of incorrect subtractions during the multitasking cognitive task Measure Description: Same serial subtraction task; performance scored as total incorrect subtractions.
次要结局
- Mood(Baseline (Visit 2; pre- and post-multitasking task) and Final (Visit 3, Day 70; pre- and post-multitasking task). Through study completion (average of 2 years).)
- State anxiety(Baseline (Visit 2; pre- and post-multitasking task) and Final (Visit 3, Day 70; pre- and post-multitasking task). Through study completion (average of 2 years).)
- Mental fatigue(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- List sorting working memory test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Sleep quality(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Trait anxiety(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Food frequnecy questionnaire(Run-in (pre-intervention), Baseline (Visit 2), Mid-Intervention, and Day 70 (Visit 3). Through study completion (average of 2 years).)
- Picture vocabulary test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Flanker inhibitory control and attention test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Dimensional changes card sort test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Pattern comparison processing speed test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Picture sequence memory test(Time Frame: Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Auditory verbal learning test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Picture sequence memory test(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Heart rate(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Interbeat interval (IBI)(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Galvanic skin response (GSR)(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Salivary alpha-amylase activity(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)
- Salivary cortisol level(Baseline (Visit 2) and Final (Visit 3, Day 70). Through study completion (average of 2 years).)