NCT05414682: MIND+SOUL Diet

Brain Healthy Soul Food Diet Intervention Among Older African Americans

Completed NA Results posted Last updated 20 October 2025

What this trial tests

NA trial testing MIND+SOUL Diet in Cardiovascular Diseases in 29 participants. Completed in 1 November 2023.

Timeline

1 August 2022

Primary endpoint
1 November 2023

1 November 2023

Quick facts

Lead sponsor	University of Kansas Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	29
Start date	1 August 2022
Primary completion	1 November 2023
Estimated completion	1 November 2023
Sites	1 location across United States

Drugs / interventions tested

• MIND+SOUL Diet

Conditions studied

• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →
• Cognitive Decline — all drugs for Cognitive Decline →

Sponsor

University of Kansas Medical Center

Who can join

55 and older, any sex, with Cardiovascular Diseases or Cognitive Decline. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility: Retention Rate Primary · 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.

Group	Value	95% CI
MIND+SOUL Diet	28	14.3 – 47.6

Total Fat Mass Secondary · Assessed at baseline and 12 weeks; 12-week data reported

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.

Group	Value	95% CI
MIND+SOUL Diet	37,395.1	± 13,218.4

Android Fat Mass Secondary · Assessed at baseline and 12 weeks; 12-week data reported

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.

Group	Value	95% CI
MIND+SOUL Diet	3,301.2	± 1,749.3

Waist Circumference Secondary · Assessed at baseline and 12 weeks; 12-week data reported

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.

Group	Value	95% CI
MIND+SOUL Diet	98.5	± 14.0

Body Mass Index Secondary · Assessed at baseline and 12 weeks; 12-week data reported

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.

Group	Value	95% CI
MIND+SOUL Diet	34.6	± 7.9

Total Cholesterol Secondary · All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.

Cardiovascular risk profile will be measured by cholesterol. Cholesterol will be measured using the PTS Diagnostics Cardiocheck Plus Analyzer Cholesterol and Glucose Check.

Cholesterol at baseline

Group	Value	95% CI
MIND+SOUL Diet	177.5	± 36.46

Cholesterol at 12-weeks

Group	Value	95% CI
MIND+SOUL Diet	181.5	± 53.88

Systolic Blood Pressure Secondary · All cardiovascular risk prolife assessments will be collected at baseline and at the 12-week mark.

Cardiovascular risk profile will be measured by systolic blood pressure. Blood pressure will be measured using the Omron 5 series blood pressure monitor. C

Systolic blood pressure at baseline

Group	Value	95% CI
MIND+SOUL Diet	127.31	± 12.421

Systolic blood pressure at 12 weeks

Group	Value	95% CI
MIND+SOUL Diet	132.40	± 14.602

Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Secondary · Self-reported dietary intake was assessed at baseline and at the 12-week follow-up.

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.

Skin Carotenoid Score (Veggie Meter) at baseline

Group	Value	95% CI
MIND+SOUL Diet	245.2	± 96.45

Skin Carotenoid Score (Veggie Meter) at 12 weeks

Group	Value	95% CI
MIND+SOUL Diet	270.9	± 91.24

Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) Secondary · Self-reported dietary intake was assessed at baseline and at the 12-week follow-up

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.

Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) at baseline

Group	Value	95% CI
MIND+SOUL Diet	0.626	± 0.5634

Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) at 12 weeks

Group	Value	95% CI
MIND+SOUL Diet	0.891	± 0.6052

Cognitive Function Secondary · Cognitive function was assessed at baseline and again at 12 weeks. The data table reports the outcome value from the 12-week time point.

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 perform

Group	Value	95% CI
MIND+SOUL Diet	90.2	± 4.1

Satisfaction - Visual Analog Scale Secondary · Satisfaction assessment will be conducted at the 12-week mark.

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.

Group	Value	95% CI
MIND+SOUL Diet	9.4	± 1.2

Acceptability Secondary · Acceptability assessment will be conducted at the 12-week mark.

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.

Group	Value	95% CI
MIND+SOUL Diet	91.8	± 11.4

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were monitored throughout the 12-week intervention period for each participant.. Reporting threshold: 0.08%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

MIND+SOUL Diet

Serious: 0/29 (0%)

Deaths: 0/29

Other adverse events (2 terms — click to expand)

Reaction	System	MIND+SOUL Diet
Dehydration	Gastrointestinal disorders	—
Bloating	Metabolism and nutrition disorders	—

Data from ClinicalTrials.gov NCT05414682 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Feasibility of the MIND+SOUL Culturally Tailored Brain Healthy Diet: A Pilot Study.
   Shaw AR, Honea R, Mudaranthakam DP, Young K, et al · · 2024 · cited 1× · PMID 39540187 · DOI 10.1177/15598276241296052