Cardiovascular DiseasesMIND+SOUL DietNCT05414682
Brain Healthy Soul Food Diet Intervention Among Older African Americans
A study testing MIND+SOUL Diet in people with Cardiovascular Diseases and Cognitive Decline, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention. Read more about this study
- Who is it for?
- Ages 55 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Cognitive Decline
- What is being tested?
- MIND+SOUL Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2022to 1 Nov 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 55 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Identify as African American or Black
- Age 55 and older
- English Proficient
- 1 or more of the following CVD risk factors (high blood pressure, high cholesterol, overweight/obesity with a BMI of 25 or more)
- Cognitively Normal with an AD8 <2 (normal cognition)
Who cannot join
- No CVD risk factors
- AD8 equal to or greater than 2
- Existing diet plan prescribed by a clinician
- Non menopausal (because of DXA scan)
- No internet connection
- Uncontrolled hypertension, by history, or as indicated by supine systolic blood pressure >165 mmHg or diastolic blood pressure >95 mmHg at the baseline visit. If an initial blood pressure reading is higher than this, an additional attempt (at this visit or on another day) could be used before excluding a patient for uncontrolled hypertension
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- Neurological diseases that impact cognition
- Other medical conditions likely to be negatively impacted by a diet change or that could confound the study data
- Unable or unwilling to provide written consent
- PI determination that study is unsafe or unsuitable
- Active depression as determined by a score of 5 or above on the PHQ9 and deemed to be clinically significant by the medical monitor
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Health System
Kansas City, Kansas, 66160
About this study
Official title: Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention.
Read the detailed description
This is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older AA (n=30). Specifically, this study aims to evaluate the feasibility and acceptability of the brain healthy soul food diet intervention. As secondary outcomes, this study aims to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older AA to form the basis of estimating power and sample size for a future full-scale randomized controlled clinical trial.
- Conditions
- Cardiovascular Diseases, Cognitive Decline
- Being tested
- MIND+SOUL Diet
- Medical subject headings
- Cardiovascular Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIND+SOUL DietOther
The MIND+SOUL Diet is an adapted brain-healthy soul food diet.
| Study group | Role | What they receive |
|---|---|---|
| MIND+SOUL Diet | Experimental | The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. Receives: Other: MIND+SOUL Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility: Retention Rate
Feasibility will be assessed by retention rate. This will be calculated as the percentage of participants who complete all aspects of the intervention including cooking classes and coach directed dietary call support.
Measured: 12 weeks
Secondary outcomes (12)
Total Fat Mass
Total fat mass was assessed using dual-energy X-ray absorptiometry (DXA) to measure total fat mass. Assessments were conducted at baseline and again at the 12-week follow-up. The values reported below reflect the 12-week follow-up, with changes calculated from baseline to 12 weeks.
Measured: Assessed at baseline and 12 weeks; 12-week data reported
Android Fat Mass
Android fat mass was assessed using dual-energy X-ray absorptiometry (DXA) to measure android fat mass. Assessments were conducted at baseline and again at the 12-week follow-up. The values reported below reflect the 12-week follow-up, with changes calculated from baseline to 12 weeks.
Measured: Assessed at baseline and 12 weeks; 12-week data reported
Waist Circumference
Waist circumference was measured using a standard tape measure at baseline and 12 weeks. Data reported reflect 12-week follow-up values for participants who completed both time points.
Measured: Assessed at baseline and 12 weeks; 12-week data reported
Body Mass Index
Body mass index was calculated using measured height and weight at baseline and 12 weeks. The value below reflects BMI at the 12-week follow-up for participants who completed both assessments.
Measured: Assessed at baseline and 12 weeks; 12-week data reported
Total Cholesterol
Cardiovascular risk profile will be measured by cholesterol. Cholesterol will be measured using the PTS Diagnostics Cardiocheck Plus Analyzer Cholesterol and Glucose Check.
Measured: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Systolic Blood Pressure
Cardiovascular risk profile will be measured by systolic blood pressure. Blood pressure will be measured using the Omron 5 series blood pressure monitor. C
Measured: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter)
Skin carotenoid levels were assessed using the Veggie Meter®, which uses reflection spectroscopy to provide an objective measure of carotenoid-rich fruit and vegetable intake. Scores typically range from 0 to 800. Higher scores indicate higher carotenoid levels and greater intake of fruits and vegetables. Changes were evaluated from baseline to 12 weeks.
Measured: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.
Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener)
Self-reported fruit and vegetable intake was assessed using the NHANES Dietary Screener Questionnaire (DSQ). The DSQ estimates average daily intake in cups per day, based on participant-reported consumption over the past 30 days. There is no fixed score range; higher estimated intake reflects greater fruit and vegetable consumption and better nutritional health. Changes were assessed from baseline to 12 weeks.
Measured: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up
Cognitive Function
Cognitive function was assessed using the NIH Toolbox Cognition Battery. The following assessments were administered to evaluate specific cognitive domains: NIH Toolbox List Sorting Working Memory Test (working memory), Picture Vocabulary Test (language), Oral Reading Recognition Test (reading), Pattern Comparison Processing Speed Test (processing speed), and Flanker Inhibitory Control and Attention Test (executive function). Each test yields a fully normed T-score ranging from 0 to 200, with a normative mean of 100 and a standard deviation of 15. Higher scores reflect better cognitive performance. This outcome specifically focuses on changes in executive function, as measured by the Flanker Inhibitory Control and Attention Test. Scores were collected at two time points: baseline and 12 weeks. The value reported in the data table reflects the mean score at 12 weeks.
Measured: Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.
Feasibility: Reasons for Refusal
Feasibility was planned to be assessed by tracking reasons for refusal to participate during the recruitment phase. Staff aimed to document participant-reported reasons for non-enrollment during initial outreach and screening efforts, however staff did not document participant-reported reasons for non-enrollment.
Measured: Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.
Satisfaction - Visual Analog Scale
Satisfaction with the MIND+SOUL diet was assessed using a Visual Analog Scale (VAS) for overall program satisfaction. The Visual Analog Scale is a single-item self-report tool ranging from 0 to 10, where 0 indicates the least amount of satisfaction and 10 indicates the highest level of satisfaction. Higher scores represent better outcomes, meaning greater satisfaction with the intervention.
Measured: Satisfaction assessment will be conducted at the 12-week mark.
Acceptability
Acceptability of the MIND+SOUL intervention was assessed using a REDCap-administered online survey developed to evaluate participant perceptions across five domains: affective attitude, burden, ethicality, perceived effectiveness, and self-efficacy. The survey includes 20 items, each scored on a 5-point Likert scale from 1 (strongly disagree) to 5 (strongly agree). The total score ranges from 20 to 100, with higher scores indicating greater acceptability of the intervention. Scores were collected at the 12-week follow-up.
Measured: Acceptability assessment will be conducted at the 12-week mark.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2022
- Study start1 Aug 2022
- Primary completion1 Nov 2023
- Study completion1 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05414682
- Sponsor's protocol ID
- 148307
- Acronym
- MIND+SOUL Diet
- Status last verified
- Sep 2025
- First submitted
- 19 May 2022
- Last updated
- 20 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw AR, Honea R, Mudaranthakam DP, Young K, Vidoni ED, Morris JK, Billinger S, Key MN, Berkley-Patton J, Burns JM. Feasibility of the MIND+SOUL Culturally Tailored Brain Healthy Diet: A Pilot Study. Am J Lifestyle Med. 2024 Oct 23:15598276241296052. doi: 10.1177/15598276241296052. Online ahead of print.
PubMed 39540187
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Healthy Soul Food Diet Intervention Among Older African Americans (Aim 2-3)
- ClinicalTrials.gov ID
- NCT05414682
- Acronym / sponsor ID
- MIND+SOUL Diet / 148307
- Conditions
- Cardiovascular Diseases, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 10 Jun 2022 (actual)
- Results
- Posted 20 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this project is to evaluate feasibility and acceptability of the MIND+SOUL diet and its implementation. Secondary goals of this project are to evaluate cardiovascular risk profile, nutritional health status, and cognition in relation to the MIND+SOUL diet intervention.
Detailed description
This is a single arm trial designed to pilot test an adapted brain healthy diet intervention among older AA (n=30). Specifically, this study aims to evaluate the feasibility and acceptability of the brain healthy soul food diet intervention. As secondary outcomes, this study aims to assess body composition, cardiovascular risk, nutritional health status, and changes in cognition among older AA to form the basis of estimating power and sample size for a future full-scale randomized controlled clinical trial.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MIND+SOUL Diet | Experimental | Other: MIND+SOUL DietThe MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Identify as African American or Black
- Age 55 and older
- English Proficient
- 1 or more of the following CVD risk factors (high blood pressure, high cholesterol, overweight/obesity with a BMI of 25 or more)
- Cognitively Normal with an AD8 <2 (normal cognition)
Key exclusion criteria (11 listed)
- No CVD risk factors
- AD8 equal to or greater than 2
- Existing diet plan prescribed by a clinician
- Non menopausal (because of DXA scan)
- No internet connection
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 |
|---|---|---|
| MIND+SOUL DietThe MIND+SOUL Diet is an adapted brain-healthy soul food diet. | Other | MIND+SOUL Diet |
Primary outcome
Feasibility: Retention Rate
Time frame: 12 weeks
Feasibility will be assessed by retention rate. This will be calculated as the percentage of participants who complete all aspects of the intervention including cooking classes and coach directed dietary call support.
12 secondary outcomes
Total Fat Mass
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Android Fat Mass
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Waist Circumference
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Body Mass Index
Time frame: Assessed at baseline and 12 weeks; 12-week data reported
Total Cholesterol
Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Systolic Blood Pressure
Time frame: All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.
Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter)
Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.
Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener)
Time frame: Self-reported dietary intake was assessed at baseline and at the 12-week follow-up
Cognitive Function
Time frame: Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.
Feasibility: Reasons for Refusal
Time frame: Reasons for refusal were supposed to be tracked throughout the recruitment period, which lasted approximately three months, but were not tracked.
Satisfaction - Visual Analog Scale
Time frame: Satisfaction assessment will be conducted at the 12-week mark.
Acceptability
Time frame: Acceptability assessment will be conducted at the 12-week mark.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39540187Shaw AR, Honea R, Mudaranthakam DP, Young K, Vidoni ED, Morris JK, Billinger S, Key MN, Berkley-Patton J, Burns JM. Feasibility of the MIND+SOUL Culturally Tailored Brain Healthy Diet: A Pilot Study. Am J Lifestyle Med. 2024 Oct 23:15598276241296052. doi: 10.1177/15598276241296052. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIND+SOUL Diet in people with Cardiovascular Diseases and Cognitive Decline, run by University of Kansas Medical Center 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 5 inclusion and 11 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 20 Oct 2025. 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?
Yes. Results are posted in the registry (first posted 20 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility: Retention Rate (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05414682, which also lists 1 linked publication.
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 20 Oct 2025.