N/A
N=29
Brain Healthy Soul Food Diet Intervention Among Older African Americans
Cardiovascular Diseases · Cognitive Decline
Bottom Line
View on ClinicalTrials.gov: NCT05414682 ↗Enrolled (actual)
29
Serious AEs
0.0%
Results posted
Oct 2025
Primary outcome: Primary: Feasibility: Retention Rate — 28 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- MIND+SOUL Diet (Other)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- University of Kansas Medical Center
- Primary completion
- Nov 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Retention Rate |
28 | — |
| SECONDARY Total Fat Mass |
37,395.1 | — |
| SECONDARY Android Fat Mass |
3,301.2 | — |
| SECONDARY Waist Circumference |
98.5 | — |
| SECONDARY Body Mass Index |
34.6 | — |
| SECONDARY Total Cholesterol |
177.5; 181.5 | — |
| SECONDARY Systolic Blood Pressure |
127.31; 132.40 | — |
| SECONDARY Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) Skin Carotenoid Score (Veggie Meter) |
245.2; 270.9 | — |
| SECONDARY Self-Reported Fruit and Vegetable Intake (NHANES Dietary Screener) |
0.626; 0.891 | — |
| SECONDARY Cognitive Function |
90.2 | — |
| SECONDARY Feasibility: Reasons for Refusal |
— | — |
| SECONDARY Satisfaction - Visual Analog Scale |
9.4 | — |
| SECONDARY Acceptability |
91.8 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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 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
- 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
Data sourced from ClinicalTrials.gov (NCT05414682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.