NCT05414682

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Aug 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2022

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 10, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
2 years until next milestone

Results Posted

Study results publicly available

October 20, 2025

Completed
Last Updated

October 20, 2025

Status Verified

September 1, 2025

Enrollment Period

1.3 years

First QC Date

May 19, 2022

Results QC Date

April 1, 2025

Last Update Submit

September 30, 2025

Conditions

Cardiovascular DiseasesCognitive Decline

Outcome Measures

Primary Outcomes (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.

    12 weeks

Secondary Outcomes (12)

  • Total Fat Mass

    Assessed at baseline and 12 weeks; 12-week data reported

  • Android Fat Mass

    Assessed at baseline and 12 weeks; 12-week data reported

  • Waist Circumference

    Assessed at baseline and 12 weeks; 12-week data reported

  • Body Mass Index

    Assessed at baseline and 12 weeks; 12-week data reported

  • Total Cholesterol

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

  • +7 more secondary outcomes

Study Arms (1)

MIND+SOUL Diet

EXPERIMENTAL

The MIND+SOUL diet is an adapted brain-healthy soul food diet. Participants follow the diet for 12 weeks.

Other: MIND+SOUL Diet

Interventions

MIND+SOUL DietOTHER

The MIND+SOUL Diet is an adapted brain-healthy soul food diet.

MIND+SOUL Diet

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Identify as African American or Black
  • Age 55 and older
  • English Proficient
  • 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)

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kansas Health System

Kansas City, Kansas, 66160, United States

Location

Related Publications (1)

  • 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.

    PMID: 39540187DERIVED

MeSH Terms

Conditions

Cardiovascular DiseasesCognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Dr. Ashley Shaw
Organization
University of Kansas Medical Center
ashaw10@kumc.edu
913-945-5023

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2022

First Posted

June 10, 2022

Study Start

August 1, 2022

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

October 20, 2025

Results First Posted

October 20, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)