Health Effects of Traditional Indigenous Chokeberry

Historical Trauma and Resilience as a Biological State and Its Association With the Effects of the Traditional Indigenous Food Chokeberry

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Oxidative Stress; Mental Health Wellness 1
• Intervention / Treatment: Other: Chokeberry (Aronia melanocarpa) juice

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.

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Dakota
    • Grand Forks, North Dakota, United States, 58202
      • University of North Dakota School of Medicine & Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Chokeberry consumption; Participants will be given 100ml of a water-infused chokeberry juice to consume twice per day for a period of 6 weeks.	Other: Chokeberry (Aronia melanocarpa) juice; A water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epigenetics	The assessment of change in methylation targeted genes	Baseline and 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary Hydroxydeoxyguanosine (8-OHdG)	A commonly used marker of oxidative stress-derived DNA assessed through urine. Assessment of the change in 8-OHdG.	Baseline and 6 weeks
Interleukin 6 (IL-6)	Is a pro-inflammatory cytokine assessed from the blood that stimulates inflammation. Assessment of the change in IL-6 processes	Baseline and 6 weeks
Lipid panel	Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels	Baseline and 6 weeks
C-reactive Protein (CRP)	Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.	Baseline and 6 weeks
Blood pressure	Measure of the change in systolic blood pressure and diastolic blood pressure	Baseline and 6 weeks
Patient Health Questionnaire-2 (PHQ-2)	Validated tool to screen for depression. Assessment of the change PHQ-2 scores. The scale runs from a minimum value of zero to a maximum value of three for each item in the questionnaire. A higher value means a worse outcome.	Baseline and 6 weeks
2-item Generalized Anxiety Disorder Scale (GAD)	Validated tool to screen for anxiety. Assessment of the change in GAD scores. The scale runs from a minimum value of zero to a maximum value of three for each item in the questionnaire. A higher value means a worse outcome.	Baseline and 6 weeks
Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)	CD-RISC2 is a brief, self-rated measure of resilience with sound psychometric properties. Assessment of the change in CD-RISC2 scores. Assessment of the change in CD-RISC2 scores. The scale runs from a minimum value of one to a maximum value of four for each item in the questionnaire. A lower value means a worse outcome.	Baseline and 6 weeks
Adverse Childhood Experiences (ACEs) survey (10-item version)	Collects some of the most intensive and frequently occurring sources of stress that children may suffer early in life.	Baseline
Historical Loss Scale	This scale enumerates perceived losses and asks respondents how frequently these losses came to mind on a 12-item questionnaire specific to Indigenous Peoples. The scale runs from a minimum value of one to a maximum value of six for each item in the questionnaire. A lower value means a worse outcome and is reported in percentage frequency of perceived losses.	Baseline

Collaborators and Investigators

• Sponsor: University of North Dakota
• Collaborators: USDA Grand Forks Human Nutrition Research Center; Altru Health System
• Investigators: Principal Investigator: Nicole Redvers, ND, MPH, University of North Dakota School of Medicine & Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Actual): January 27, 2023
• Study Completion (Actual): January 27, 2023

Study Registration Dates

• First Submitted: May 26, 2022
• First Submitted That Met QC Criteria: June 2, 2022
• First Posted (Actual): June 8, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Epigenetics; American Indian; chokeberry; Aronia melanocarpa; Historical Trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation
• Other Study ID Numbers: UND0027177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No