Brain Healthy Soul Food Diet Intervention Among Older African Americans (MIND+SOUL Diet)

University of Kansas

Status: Completed

Conditions: Cognitive Decline; Cardiovascular Diseases

Treatments: Other: MIND+SOUL Diet

Study type: Interventional

Funder types: Other

Identifiers

NCT05414682

148307

Details and patient eligibility

About

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.

Full 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.

Enrollment: 29 patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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 <2 (normal cognition)

Exclusion criteria

• 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

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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29 participants in 1 patient group

MIND+SOUL Diet

Experimental group

Description:

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

Treatment:

Other: MIND+SOUL Diet