Health Effects of Traditional Indigenous Chokeberry

NCT05410327 | Completed DMC

• 1 other identifier: UND0027177
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Mental Health Wellness 1; Oxidative Stress

Keywords

American Indian; Epigenetics; chokeberry; Aronia melanocarpa; Historical Trauma

Outcome Measures

Primary Outcomes (1)

• Epigenetics

  The assessment of change in methylation targeted genes

  Baseline and 6 weeks

Secondary Outcomes (10)

• Urinary Hydroxydeoxyguanosine (8-OHdG)

  Baseline and 6 weeks

• Interleukin 6 (IL-6)

  Baseline and 6 weeks

• Lipid panel

  Baseline and 6 weeks

• C-reactive Protein (CRP)

  Baseline and 6 weeks

• Blood pressure

  Baseline and 6 weeks

Study Arms (1)

Chokeberry consumption

EXPERIMENTAL

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

Interventions

Chokeberry (Aronia melanocarpa) juice OTHER

A water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'.

Chokeberry consumption

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Dakota: lead
• USDA Grand Forks Human Nutrition Research Center: collaborator
• Altru Health System: collaborator

Study Sites (1)

University of North Dakota School of Medicine & Health Sciences

Grand Forks, North Dakota, 58202, United States

Location

MeSH Terms

Conditions

Inflammation; Historical Trauma

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Psychological Trauma; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Nicole Redvers, ND, MPH

  University of North Dakota School of Medicine & Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 8, 2022
• Study Start: July 13, 2022
• Primary Completion: January 27, 2023
• Study Completion: January 27, 2023
• Last Updated: May 1, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)