Clinical trial NCT05410327: Health Effects of Traditional Indigenous Chokeberry
Official title: Historical Trauma and Resilience as a Biological State and Its Association With the Effects of the Traditional Indigenous Food Chokeberry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation
Mental Health Wellness 1
Oxidative Stress
Keywords: American Indian
Epigenetics
chokeberry
Aronia melanocarpa
Historical Trauma
Lead sponsor: University of North Dakota
Sponsor class: OTHER
Collaborators: name: USDA Grand Forks Human Nutrition Research Center
name: Altru Health System
First posted: 2022-06-08
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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:

1. If there are gene expression changes that are mediated by consumption of traditional Indigenous chokeberry in urban adult Great Plains Indians.
2. 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.

Eligibility criteria: Inclusion Criteria:

* Great Plains located American Indians
* Adults between the ages of 18-65

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Epigenetics
timeFrame: Baseline and 6 weeks
Secondary outcomes:
measure: Urinary Hydroxydeoxyguanosine (8-OHdG)
timeFrame: Baseline and 6 weeks
measure: Interleukin 6 (IL-6)
timeFrame: Baseline and 6 weeks
measure: Lipid panel
timeFrame: Baseline and 6 weeks
measure: C-reactive Protein (CRP)
timeFrame: Baseline and 6 weeks
measure: Blood pressure
timeFrame: Baseline and 6 weeks
measure: Patient Health Questionnaire-2 (PHQ-2)
timeFrame: Baseline and 6 weeks
measure: 2-item Generalized Anxiety Disorder Scale (GAD)
timeFrame: Baseline and 6 weeks
measure: Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)
timeFrame: Baseline and 6 weeks
measure: Adverse Childhood Experiences (ACEs) survey (10-item version)
timeFrame: Baseline
measure: Historical Loss Scale
timeFrame: Baseline
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: University of North Dakota School of Medicine & Health Sciences
state: North Dakota
Study officials:
affiliation: University of North Dakota School of Medicine & Health Sciences
name: Nicole Redvers, ND, MPH
role: PRINCIPAL_INVESTIGATOR
References: