InflammationNCT05410327
Health Effects of Traditional Indigenous Chokeberry
A study testing Chokeberry (Aronia melanocarpa) juice in people with Inflammation and Mental Health Wellness 1, run by University of North Dakota at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Mental Health Wellness 1, Oxidative Stress
- What is being tested?
- Chokeberry (Aronia melanocarpa) juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Jul 2022to 27 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Great Plains located American Indians
- Adults between the ages of 18-65
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Dakota School of Medicine & Health Sciences
Grand Forks, North Dakota, 58202
About this study
Official title: Historical Trauma and Resilience as a Biological State and Its Association With the Effects of the Traditional Indigenous Food 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.
Read the 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.
- Conditions
- Inflammation, Mental Health Wellness 1, Oxidative Stress
- Being tested
- Chokeberry (Aronia melanocarpa) juice
- Keywords
- American Indian, Epigenetics, chokeberry, Aronia melanocarpa, Historical Trauma
- Medical subject headings
- Inflammation, Historical Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chokeberry (Aronia melanocarpa) juiceOther
A water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Chokeberry (Aronia melanocarpa) juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epigenetics
The assessment of change in methylation targeted genes
Measured: Baseline and 6 weeks
Secondary outcomes (10)
Urinary Hydroxydeoxyguanosine (8-OHdG)
A commonly used marker of oxidative stress-derived DNA assessed through urine. Assessment of the change in 8-OHdG.
Measured: Baseline and 6 weeks
Interleukin 6 (IL-6)
Is a pro-inflammatory cytokine assessed from the blood that stimulates inflammation. Assessment of the change in IL-6 processes
Measured: Baseline and 6 weeks
Lipid panel
Assessment of the change in HDL, LDL, total cholesterol, triglycerides levels
Measured: Baseline and 6 weeks
C-reactive Protein (CRP)
Measure of systemic inflammation assessed from the blood. Assessment of the change in CRP.
Measured: Baseline and 6 weeks
Blood pressure
Measure of the change in systolic blood pressure and diastolic blood pressure
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2022
- Study start13 Jul 2022
- Primary completion27 Jan 2023
- Study completion27 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Dakota
- Sponsor type
- University, hospital or other
- Collaborators
- USDA Grand Forks Human Nutrition Research Center, Altru Health System
- Responsible party
- Sponsor
- Investigators
- Nicole Redvers, ND, MPH, Principal investigator, University of North Dakota School of Medicine & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05410327
- Sponsor's protocol ID
- UND0027177
- Status last verified
- Apr 2023
- First submitted
- 26 May 2022
- Last updated
- 1 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Historical Trauma and Resilience as a Biological State and Its Association With the Effects of the Traditional Indigenous Food Chokeberry
- ClinicalTrials.gov ID
- NCT05410327
- Acronym / sponsor ID
- UND0027177
- Conditions
- Inflammation, Mental Health Wellness 1, Oxidative Stress
- Keywords
- American Indian, Epigenetics, chokeberry, Aronia melanocarpa, Historical Trauma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of North DakotaUniversity, hospital or other
- Collaborators
- USDA Grand Forks Human Nutrition Research Center, Altru Health System
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 27 Jan 2023 (actual)
- Study completion
- 27 Jan 2023 (actual)
- First posted
- 8 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chokeberry consumption | Experimental | Other: Chokeberry (Aronia melanocarpa) juiceParticipants will be given 100ml of a water-infused chokeberry juice to consume twice per day for a period of 6 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Great Plains located American Indians
- Adults between the ages of 18-65
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Chokeberry (Aronia melanocarpa) juiceA water-infused chokeberry (Aronia melanocarpa) juice will be used as the intervention. The brand being used is called 'Superberries'. | Other | Chokeberry consumption |
Primary outcome
Epigenetics
Time frame: Baseline and 6 weeks
The assessment of change in methylation targeted genes
10 secondary outcomes
Urinary Hydroxydeoxyguanosine (8-OHdG)
Time frame: Baseline and 6 weeks
Interleukin 6 (IL-6)
Time frame: Baseline and 6 weeks
Lipid panel
Time frame: Baseline and 6 weeks
C-reactive Protein (CRP)
Time frame: Baseline and 6 weeks
Blood pressure
Time frame: Baseline and 6 weeks
Patient Health Questionnaire-2 (PHQ-2)
Time frame: Baseline and 6 weeks
2-item Generalized Anxiety Disorder Scale (GAD)
Time frame: Baseline and 6 weeks
Connor-Davidson Resilience Scale 2-item measure (CD-RISC2)
Time frame: Baseline and 6 weeks
Adverse Childhood Experiences (ACEs) survey (10-item version)
Time frame: Baseline
Historical Loss Scale
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Redvers, ND, MPH principal investigator
University of North Dakota School of Medicine & Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Chokeberry (Aronia melanocarpa) juice in people with Inflammation and Mental Health Wellness 1, run by University of North Dakota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epigenetics (time frame: Baseline and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2023.