Health Effects of Traditional Indigenous Chokeberry

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05410327
• Other study ID #: UND0027177
• Status: Completed
• Phase: N/A
• Start date: July 13, 2022
• Est. completion date: January 27, 2023

Study information

• Verified date: April 2023
• Source: University of North Dakota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 27, 2023
• Est. primary completion date: January 27, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inflammation
• Mental Health Wellness 1
• Oxidative Stress

Intervention

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'.

Locations

Country	Name	City	State
United States	University of North Dakota School of Medicine & Health Sciences	Grand Forks	North Dakota

Sponsors (3)

Lead Sponsor	Collaborator
University of North Dakota	Altru Health System, USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Epigenetics	The assessment of change in methylation targeted genes	Baseline and 6 weeks
Secondary	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
Secondary	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
Secondary	Lipid panel	Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels	Baseline and 6 weeks
Secondary	C-reactive Protein (CRP)	Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.	Baseline and 6 weeks
Secondary	Blood pressure	Measure of the change in systolic blood pressure and diastolic blood pressure	Baseline and 6 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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