NCT07348406招募中1 期
Effects of Pecans on Brain Health in Older Americans With Mild Cognitive Impairment: Gut-brain Axis
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- fMRI measures
研究概览
简要总结
This project will investigate whether daily snack consumption can improve memory, mood, and overall brain function in people with cognitive impairment. Sixty participants, aged 50 and older, with cognitive impairment, will be randomly assigned to eat snacks, either pecans or pretzels, for three months. Researchers will also study how snacks (pecans and pretzels) may influence the body, including changes in gut bacteria, blood markers of inflammation, and signals that connect the gut and the brain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men and women > 50 years-old
- •self-reported IQCODE (informant questionnaire on cognitive decline in the elderly) average score < 4.5
- •self-reported significant functional impairment (related to cognitive impairment) in basic or advanced activities of daily living as evidenced by the Activities of Daily Living (ADLs) questionnaire. If answers to at least one endorsement in the "NO, dependence due to memory concerns".
- •Stable medications (≥ 12-week unchanged dose before baseline) with no planned changes during trial.
- •habitually consume less than two servings (2 ozs = 1/4 cup) of nuts or nut spreads per week
- •willing to accept randomization
排除标准
- •reported nut allergy or intolerance
- •self-reported untreated hypothyroidism, severe liver disease, or end-stage chronic kidney disease
- •heavy alcohol drinker: in the past 3 months: men ≥14 drinks/week or women ≥7 drinks/week
- •recent (<1 month) appearance of diarrhea or hematochezia before study intervention begins. Rationale: A one-month waiting period after diarrhea or hematochezia (blood in stool) is recommended for a gut microbiome test to ensure the results accurately reflect the state and microbial composition, since diarrhea and hematochezia can significantly alter the gut environment and skew test results.
- •recent (<1 month) exposure to antibiotics before study intervention begins. Rationale: A one-month waiting period after antibiotics is recommended for a gut microbiome test because it allows the microbial community time to recover and reach a more stable state, ensuring a more accurate and representative snapshot of the gut microbiome composition, since antibiotic usage can significantly reduce microbial diversity.
- •Self-reported unstable GI disorder
- •likeliness of moving during the trial, lack of transportation, or unavailability at sample collection times
研究组 & 干预措施
Pecan
Active Comparator
2.0 oz pecans daily for 3 months
干预措施: Pecan snack (Biological)
Pretzel
Placebo Comparator
3.5 oz pretzel snack daily for 3 months
干预措施: Pretzel snack (Biological)
结局指标
主要结局
fMRI measures
时间窗: baseline and after 3 months
connectivity of amygdala seed regions and broader bilateral mPFC using fMRI
次要结局
- NACC Uniform Data Set(baseline and after 3 months)
- Wisconsin Card Sorting Test(baseline and after 3 months)
- California Verbal Learning Test(baseline and after 3 months)
- Clock Draw Test(baseline and after 3 months)
- TRAILS A and B(baseline and after 3 months)
- Geriatric Depression Scale (GDS-15)(baseline and after 3 months)
- Beck Anxiety Inventory (BAI)(baseline and after 3 months)
- fecal zonulin concentration by ELISA(baseline and after 3 months)
- gut microbiome(baseline and after 3 months)
- fecal metabolites(baseline and after 3 months)
- neuroinflammation gene(baseline and after 3 months)
研究者
研究点 (1)
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