Historical Trauma and Resilience as a Biological State and Its Association With the Effects of the Traditional Indigenous Food Chokeberry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 2
- 主要终点
- Epigenetics
研究概览
简要总结
American Indian populations continue to suffer disproportionately from health problems including such nutrition-related chronic diseases as diabetes and heart disease. This research project will therefore investigate how a traditional Indigenous food called chokeberry (Aronia melanocarpa) impacts epigenetic and metabolic health in relation to resiliency markers in American Indian participants. The process of research with American Indian communities is significant in that it can inform best practices in community engagement orientations, approaches, and models in future research settings.
详细描述
This study aims to explore the gene expression and metabolic changes that are mediated by consumption of Indigenous chokeberry (Aronia melanocarpa) in adult urban American Indians and to examine the associations between metabolic endpoints, adverse childhood experiences and mental health. The investigators are doing this research study to answer questions about the impact of adult urban American Indians ingesting one of their traditional Indigenous foods called chokeberry on epigenetic, metabolic and mental health markers of trauma and resilience.
For this study, the investigators will be looking to determine:
- If there are gene expression changes that are mediated by consumption of traditional Indigenous chokeberry in urban adult Great Plains Indians.
- If there are associations between secondary outcomes such as metabolic endpoints (i.e., 8-OHdG, IL-6, lipids, glucose, CRP, blood pressure), epigenetic states, adverse childhood experiences, and mental health (historical trauma, resiliency, presence of anxiety and depression) in American Indians who have or have not consumed chokeberry as part of a controlled feeding study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Great Plains located American Indians
- •Adults between the ages of 18-65
排除标准
- •Individuals on blood thinning medications, insulin, those pregnant or breastfeeding and those unable to comply with the research schedule, those who have had stomach or upper gastric resection, those on biologic, chemotherapy and immune suppressant medications, those over 65 years of age due to substantially changing metabolic profiles, and those who have started a new hyperglycemic, hypercholesterolemia, anti-depressant, anti-anxiety, or anti-psychotic medication(s) in the last two months.
- •Those who have a current consumption history of chokeberry use (defined by regular use in the last 6 months) or those with a known allergy to chokeberry will also be excluded.
- •Those with an acute infection in the last month, those with a vaccination in the last two months, and those on NSAIDS within 93.5 hours of testing may be able to still participate if they do not carry these exclusions in the next testing period.
结局指标
主要结局
Epigenetics
时间窗: Baseline and 6 weeks
The assessment of change in methylation targeted genes
次要结局
- Historical Loss Scale(Baseline)
- Interleukin 6 (IL-6)(Baseline and 6 weeks)
- Blood pressure(Baseline and 6 weeks)
- 2-item Generalized Anxiety Disorder Scale (GAD)(Baseline and 6 weeks)
- Adverse Childhood Experiences (ACEs) survey (10-item version)(Baseline)
- Urinary Hydroxydeoxyguanosine (8-OHdG)(Baseline and 6 weeks)
- Lipid panel(Baseline and 6 weeks)
- C-reactive Protein (CRP)(Baseline and 6 weeks)
- Patient Health Questionnaire-2 (PHQ-2)(Baseline and 6 weeks)
- Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)(Baseline and 6 weeks)