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Completed

NCT Number: NCT05410327

Health Effects of Traditional Indigenous 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.

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Key information

Conditions

Inflammation Historical Trauma Mental Disorders Mental Health Wellness 1 Oxidative Stress Pathologic Processes Pathological Conditions, Signs and Symptoms Psychological Trauma Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Dakota School of Medicine & Health Sciences

Grand Forks, North Dakota, 58202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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'.

Primary outcomes

  1. Epigenetics

    Time frame: Baseline and 6 weeks

    The assessment of change in methylation targeted genes

Secondary outcomes

  1. Urinary Hydroxydeoxyguanosine (8-OHdG)

    Time frame: Baseline and 6 weeks

    A commonly used marker of oxidative stress-derived DNA assessed through urine. Assessment of the change in 8-OHdG.

  2. Interleukin 6 (IL-6)

    Time frame: Baseline and 6 weeks

    Is a pro-inflammatory cytokine assessed from the blood that stimulates inflammation. Assessment of the change in IL-6 processes

  3. Lipid panel

    Time frame: Baseline and 6 weeks

    Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels

  4. C-reactive Protein (CRP)

    Time frame: Baseline and 6 weeks

    Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.

  5. Blood pressure

    Time frame: Baseline and 6 weeks

    Measure of the change in systolic blood pressure and diastolic blood pressure

  6. Patient Health Questionnaire-2 (PHQ-2)

    Time frame: Baseline and 6 weeks

    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.

  7. 2-item Generalized Anxiety Disorder Scale (GAD)

    Time frame: Baseline and 6 weeks

    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.

  8. Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)

    Time frame: Baseline and 6 weeks

    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.

  9. Adverse Childhood Experiences (ACEs) survey (10-item version)

    Time frame: Baseline

    Collects some of the most intensive and frequently occurring sources of stress that children may suffer early in life.

  10. Historical Loss Scale

    Time frame: Baseline

    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.

Sponsors and collaborators

Lead sponsor

University of North Dakota

Other

Collaborators

  • Altru Health System
  • USDA Grand Forks Human Nutrition Research Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 8, 2022
Registry last updated
May 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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