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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in United States

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.

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 groups in NCT05414682
Study groupRoleWhat they receive
MIND+SOUL DietExperimentalThe 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  1. First posted10 Jun 2022
  2. Study start1 Aug 2022
  3. Primary completion1 Nov 2023
  4. Study completion1 Nov 2023

Resources

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)
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
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

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.

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