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Health Effects of Traditional Indigenous Chokeberry

Primary Purpose

Inflammation, Mental Health Wellness 1, Oxidative Stress

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Chokeberry (Aronia melanocarpa) juice
Sponsored by
University of North Dakota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Inflammation focused on measuring American Indian, Epigenetics, chokeberry, Aronia melanocarpa, Historical Trauma

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • University of North Dakota School of Medicine & Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chokeberry consumption

Arm Description

Participants will be given 100ml of a water-infused chokeberry juice to consume twice per day for a period of 6 weeks.

Outcomes

Primary Outcome Measures

Epigenetics
The assessment of change in methylation targeted genes

Secondary Outcome Measures

Urinary Hydroxydeoxyguanosine (8-OHdG)
A commonly used marker of oxidative stress-derived DNA assessed through urine. Assessment of the change in 8-OHdG.
Interleukin 6 (IL-6)
Is a pro-inflammatory cytokine assessed from the blood that stimulates inflammation. Assessment of the change in IL-6 processes
Lipid panel
Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels
C-reactive Protein (CRP)
Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.
Blood pressure
Measure of the change in systolic blood pressure and diastolic blood pressure
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.
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.
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.
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.
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.

Full Information

First Posted
May 26, 2022
Last Updated
April 27, 2023
Sponsor
University of North Dakota
Collaborators
USDA Grand Forks Human Nutrition Research Center, Altru Health System
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1. Study Identification

Unique Protocol Identification Number
NCT05410327
Brief Title
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

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 13, 2022 (Actual)
Primary Completion Date
January 27, 2023 (Actual)
Study Completion Date
January 27, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Dakota
Collaborators
USDA Grand Forks Human Nutrition Research Center, Altru Health System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Mental Health Wellness 1, Oxidative Stress
Keywords
American Indian, Epigenetics, chokeberry, Aronia melanocarpa, Historical Trauma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chokeberry consumption
Arm Type
Experimental
Arm Description
Participants will be given 100ml of a water-infused chokeberry juice to consume twice per day for a period of 6 weeks.
Intervention Type
Other
Intervention Name(s)
Chokeberry (Aronia melanocarpa) juice
Intervention Description
A water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'.
Primary Outcome Measure Information:
Title
Epigenetics
Description
The assessment of change in methylation targeted genes
Time Frame
Baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Urinary Hydroxydeoxyguanosine (8-OHdG)
Description
A commonly used marker of oxidative stress-derived DNA assessed through urine. Assessment of the change in 8-OHdG.
Time Frame
Baseline and 6 weeks
Title
Interleukin 6 (IL-6)
Description
Is a pro-inflammatory cytokine assessed from the blood that stimulates inflammation. Assessment of the change in IL-6 processes
Time Frame
Baseline and 6 weeks
Title
Lipid panel
Description
Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels
Time Frame
Baseline and 6 weeks
Title
C-reactive Protein (CRP)
Description
Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.
Time Frame
Baseline and 6 weeks
Title
Blood pressure
Description
Measure of the change in systolic blood pressure and diastolic blood pressure
Time Frame
Baseline and 6 weeks
Title
Patient Health Questionnaire-2 (PHQ-2)
Description
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.
Time Frame
Baseline and 6 weeks
Title
2-item Generalized Anxiety Disorder Scale (GAD)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)
Description
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.
Time Frame
Baseline and 6 weeks
Title
Adverse Childhood Experiences (ACEs) survey (10-item version)
Description
Collects some of the most intensive and frequently occurring sources of stress that children may suffer early in life.
Time Frame
Baseline
Title
Historical Loss Scale
Description
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.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicole Redvers, ND, MPH
Organizational Affiliation
University of North Dakota School of Medicine & Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Dakota School of Medicine & Health Sciences
City
Grand Forks
State/Province
North Dakota
ZIP/Postal Code
58202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Health Effects of Traditional Indigenous Chokeberry

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