Acute and Chronic Impacts of Muscadine Wine Polyphenols on Cognition, Memory, Mood, and Anxiety in Adults Over 50 Years of Age
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change from baseline cognitive performance score after intervention/placebo - continued
研究概览
简要总结
Previous studies have shown that polyphenol-rich foods can positively affect cognitive functions, memory, and mood in humans. We hypothesize that both acute and chronic intake of muscadine wine polyphenols will improve cognitive performance and mood through regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities
详细描述
Although the exact biological mechanisms for depression and Alzheimer's Disease are not fully understood, it's believed that they are caused by a combination of factors. An increasing amount of scientific research has proposed several possible pathophysiologies linking depression and AD. For example, increased production of pro-inflammatory cytokines in the nervous system, oxidative stress induced by chronic inflammation leads to dysregulation of the hypothalamic-pituitary-adrenal (HPA) axis, and disturbance in the brain-derived neurotrophic factor signal pathway. Polyphenol has been well recognized for its antioxidant and anti-inflammatory properties. Previous studies have shown that polyphenol-rich food such as concord grape juice, blueberries, blackcurrants, and green oats positively affect cognition, memory, and mood in humans. However, no one has examined the effects of muscadine wine polyphenol on cognitive and mental health. In addition, if they do have effects, through what mechanism? This clinical trial will allow us to investigate the questions raised. We hypothesize that intake of muscadine wine polyphenols enhances cognition and memory and improve depression and anxiety in healthy adults over 50 year-old via regulating the HPA axis, alleviating inflammation and oxidative stress, and/or inhibiting monoamine oxidase activities. The research will provide the first clinical evidence of how muscadine wine polyphenols affect the brain and mental health.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI (18.5-29.9)
- •Body weight ≥110 pounds
排除标准
- •Pregnancy
- •Breast-feeding
- •Heavy drinkers
- •Subjective but not clinically diagnosed cognitive impairment (Montreal cognitive assessment score <26),
- •Inability to understand the cognitive function tasks
- •Intake of medication that might influence the outcome of the study (e.g. psychostimulant)
- •cannabis product user
- •Clinically diagnosed mental illnesses
- •Cardiovascular and neurological disorders
- •Uncontrolled hypertension
研究组 & 干预措施
Intervention-Placebo
Participants in this arm will consume muscadine wine polyphenol for six weeks and then placebo for another six weeks. The two phases are separated by a 21-day washout period
干预措施: Placebo (Other)
Placebo-Intervention
Participants in this arm will first consume placebo for six weeks and then muscadine wine polyphenol for another six weeks. The two phases are separated by a 21-day washout period
干预措施: Muscadine Wine Polyphenol (Other)
Placebo-Intervention
Participants in this arm will first consume placebo for six weeks and then muscadine wine polyphenol for another six weeks. The two phases are separated by a 21-day washout period
干预措施: Placebo (Other)
Intervention-Placebo
Participants in this arm will consume muscadine wine polyphenol for six weeks and then placebo for another six weeks. The two phases are separated by a 21-day washout period
干预措施: Muscadine Wine Polyphenol (Other)
结局指标
主要结局
Change from baseline cognitive performance score after intervention/placebo - continued
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
3\. Picture Sequence Test (episodic memory): Item Response Theory (IRT) is used to score this test. score known as a theta score is calculated for each participant; it represents the relative overall ability or performance of the participant. A theta score is very similar to a z-score, which is a statistic with a mean of zero and a standard deviation of one. The higher the score, the better the performance. 4. List Sorting Test (working memory: scored by summing the total number of items correctly recalled and sequenced on the tests, which can range from 0-26. 5. Pattern and Comparison Test (processing speed): The participant's raw score is the number of items answered correctly in 85 seconds of response time, with a range of 0-130. higher score means better performance. Both individual test scores and composite scores will be compared to baseline score
Change from baseline neurotransmitters
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels of acetylcholine, dopamine, melatonin, serotonin, epinephrine, and γ-aminobutyric acid (GABA) will be quantified using the targeted metabolomic method on UHPLC-MS/MS
Change from baseline brain-derived neurotrophic factors
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
plasma BDNF will be measured using ELISA
Change from baseline cortisol, TNF-α, high sensitivity C-reactive protein, and LPS binding protein
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
Plasma levels will be measured using ELISA
Change from baseline monoamine oxidase (MAOs) activity
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
Blood samples will be drawn immediately after the completion test battery. Blood plasma level of monoamine oxidase (MAOs) activity will be determined using the Amplex Red Monoamine Oxidase Assay Kit to assess the inhibitory effects of muscadine wine/juice on MAOs.
Change from baseline cognitive performance score after intervention/placebo
时间窗: Baseline, acute (4-hour post single dose), chronic (end of six week)
Participants will complete the NIH Toolbox cognitive battery. The test battery incorporates multiple tests that assess various aspects of cognitive performance. The list of tests and the function they measure are the following.1. Flanker inhibitory control and attention test (executive function): scoring is based on a combination of accuracy and reaction time. A 2-vector scoring method is employed that uses accuracy and reaction time, where each of these vectors ranges in value between 0 and 5, and the computed score, combining each vector score, ranges in value 0-10. The higher the score the better the performance. 2. Dimensional Change Card Sort (cognitive flexibility): scoring is the same as Flanker's test.
次要结局
- Change from baseline mood and anxiety score after intervention/placebo(Baseline, acute (4-hour post single dose), chronic (end of six week))
- Change from baseline depression score after intervention/placebo(Baseline, acute (4-hour post single dose), chronic (end of six week))
- Change from baseline pro-inflammatory cytokines(Baseline, acute (4-hour post single dose), chronic (end of six week))