Effect of Daily Walnut Consumption on Memory in Subjects With Long-COVID
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Episodic Memory - RAVLT-Revised Long-Delay Free Recall (number of words recalled)
研究概览
简要总结
Approximately 30% of patients experience "Long-COVID" syndrome presenting with symptoms such as cognitive difficulties ('brain fog'), fatigue, dyspnea, autonomic dysfunction, depression and anxiety, lasting beyond 12 weeks causing significant disability, and threaten health and wellbeing of millions around the world. At the current time, there is no effective treatment for long-COVID. Walnuts contain a mixture of nutrients and phytochemicals include monounsaturated fatty acids (MUFA), polyunsaturated fatty acids (PUFA), and alpha-linolenic acid (ALA). Walnut consumption was directly associated with cognitive function. The investigators have shown pomegranate that share the same phytonutrient ellagitannins as walnut and mixed nuts including walnuts could increase blood microbiome metabolites of tryptophan metabolite indole propionate and serotonin levels via change of gut microbiota and therefore play an essential role in gut-brain axis including cognitive function. The proposed pilot study will include 76 adults (ages >40 years) with diagnosis of SARS-CoV2 infection presenting with long-COVID symptoms lasting longer than 12 weeks. They will be randomized 1:1 to usual care vs. an intervention group that will include 2 oz (57g) of walnuts daily into their habitual diet for 12 weeks. The investigators will compare the improvement in symptoms of cognitive complains of "brain fog", fatigue and depression of the active intervention group vs. usual care. The outcome of the investigation of the benefit of walnut consumption will provide important novel information on using dietary sources of polyunsaturated fatty acids and phytochemicals to mitigate the common symptoms of long-COVID. This application was submitted in response to the California Walnut Commission's commodity board topic.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40 years and older
- •History of confirmed SARS-CoV-2 infection
- •Presence of long-COVID symptoms lasting longer than 12 weeks, including one or more of the following:
- •Cognitive complaints ("brain fog," memory, attention, or processing speed difficulties)
- •Mood symptoms (e.g., depression)
- •Consumption of a low-polyphenol (Western) diet
- •Adequate visual acuity and hearing to complete neuropsychological testing
- •Screening laboratory results without clinically significant abnormalities that would interfere with study participation
- •Ability and willingness to provide written informed consent
排除标准
- •Diagnosis of probable Alzheimer's disease or other dementia (e.g., vascular, Lewy body, frontotemporal)
- •Other neurological or medical conditions that may cause cognitive impairment
- •Evidence of Parkinson's disease based on motor examination
- •Uncontrolled hypertension (systolic BP >170 mmHg or diastolic BP >100 mmHg)
- •Allergy to walnuts
- •Regular consumption of more than 5 oz of walnuts per week
- •Current diagnosis of a major psychiatric disorder according to DSM-5 criteria
- •Alcoholism or substance use disorder
- •Any condition that, in the investigator's judgment, would make participation unsafe or interfere with study completion
研究组 & 干预措施
Walnuts
干预措施: whole food - walnuts (Other)
Control
Habitual diet while avoiding nuts
结局指标
主要结局
Episodic Memory - RAVLT-Revised Long-Delay Free Recall (number of words recalled)
时间窗: Baseline to Week 12
Change in long-delay free recall score (number of words correctly recalled) on the RAVLT-Revised from baseline to week 12.
次要结局
- Blood Pressure(Baseline and Week 12)
- Dietary Intake(Baseline and 12)
- Blood and Urine Biomarkers(Baseline, 12 Weeks)
- WAIS-IV Symbol Search Score(Baseline and 12 weeks)
- Heart Rate(Baseline and Week 12)
- Body Weight(baseline and week 12)
- Executive Function(Baseline to Week 12)
- Trail Making Test Part A Completion Time(baseline and 12 weeks)
- Fatigue(Baseline and 12)
- Mood(baseline and 12 weeks)
- NIH Toolbox Cognitive Battery (NIHTB-CB) - Fluid Intelligence Composite(Baseline to Week 12)
- Quality of Life(Baseline and 12)
研究者
Zhaoping Li
Professor of Medicine and Chief of the Division of Clinical Nutrition at the University of California, Los Angeles
University of California, Los Angeles