Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| USDA Grand Forks Human Nutrition Research Center | FED |
| Altru Health System | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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:
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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'. |
| Measure | Description | Time Frame |
|---|---|---|
| Epigenetics | The assessment of change in methylation targeted genes | Baseline and 6 weeks |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nicole Redvers, ND, MPH | University of North Dakota School of Medicine & Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Dakota School of Medicine & Health Sciences | Grand Forks | North Dakota | 58202 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 30, 2024 | |
| Reset | Sep 3, 2024 | |
| Release | Sep 27, 2024 | |
| Reset | Oct 15, 2024 | |
| Release | Dec 4, 2024 | |
| Reset | Dec 23, 2024 |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2021 | Jun 1, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 31, 2022 | May 26, 2022 | ICF_001.pdf |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 30, 2024 | Sep 3, 2024 | |||
| Sep 27, 2024 |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| D000080037 | Historical Trauma |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000067073 | Psychological Trauma |
| D040921 | Stress Disorders, Traumatic |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| Oct 15, 2024 |
| Dec 4, 2024 | Dec 23, 2024 |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |