Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure

Not Applicable

Withdrawn

• Conditions: Heart Failure With Preserved Ejection Fraction; Heart Failure
• Interventions: Other: Usual diet; Other: DASH Diet

• Registration Number: NCT04113291
• Lead Sponsor: Wake Forest University Health Sciences

Brief Summary

This is a study of the DASH diet (Dietary Approaches to Stop Hypertension) in the exploration of effective strategies for Heart failure (HF) with preserved ejection fraction (HFPEF) prevention.

Detailed Description

This is a feasibility pilot, randomized clinical trial (RCT), DASH diet feeding trial in 40 older adults. It will also elicit trends in left ventricular remodeling and pathophysiology. This trial investigates the feasibility of performing a DASH diet RCT intervention in HFPEF prevention in older adults of low socioeconomic status (LSES).

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2019-10-01
• Study First Submitted QC: 2019-10-01
• Study First Posted: 2019-10-02
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-01
• Last Update Posted: 2020-10-05
• Study Start: 2021-12
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Participants will have an education level of less than college as a surrogate marker of LSES.

Read More

Exclusion Criteria

• Participants should not have a diagnosis of heart failure or loop diuretics on their medication list in the EHR or symptoms of dyspnea, edema (assessed via questionnaire)
• poorly controlled diabetes mellitus ( HBA 1c >9%)
• or uncontrolled hypertension ( SBP>180, DBP>110)
• cardiovascular event (MI, stroke, HF, angina, atrial fibrillation) within the previous six months
• chronic diseases that might interfere with participation (dementia, schizophrenia, dialysis or transplant recipient patients)
• body-mass index (the weight in kilograms divided by the square of the height in meters) of more than 35

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Attention Control Group	Usual diet	Participants randomized to attention control will continue their usual diet, but they will be instructed to limit their sodium intake to 2300 mg/day. They will be requested and voluntarily agree to not make additional diet or exercise changes during the 12-week study.
DASH diet group	DASH Diet	Participants randomized to receive the DASH diet will be prescribed an isocaloric DASH diet using meals (lunch, dinner, snacks) prepared by a Clinical Research Metabolic Kitchen under the direction of a registered dietician. Participants will prepare their own breakfast from a menu. The subjects will be instructed to drink no more than three caffeinated beverages and no more than two alcoholic beverages per day.

Primary Outcome Measures

Name	Time	Method
Number of enrolled participants per week	Up to week 12
Proportion of participants that adhere to the to intervention	Up to week 12
Number participants that were retained in the trial	Up to week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of participants that adhere to the diet	Up to week 12

Trial Locations

Locations (1)

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States