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

Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure

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.

Study Overview

• Status: Withdrawn
• Conditions: Heart Failure; Heart Failure With Preserved Ejection Fraction
• Intervention / Treatment: Other: DASH Diet; Other: Usual diet

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).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DASH diet group; 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.	Other: DASH Diet; 12 Weeks of isocaloric DASH diet <2300 mg Na/day using meals (lunch, dinner, snacks) prepared by the Wake Forest Clinical Research Metabolic Kitchen under the direction of a registered dietician (RD). 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.; Other Names: Dietary Approaches to Stop Hypertension
Active Comparator: Attention Control Group; 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.	Other: Usual diet; 12 weeks usual diet <2300 mg Na/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Proportion of participants that adhere to the diet	Up to week 12

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	Weight (kilograms)	Baseline
Weight	Weight (kilograms)	After intervention, Week 12
Waist circumference	Waist circumference (cm)	Baseline
Waist circumference	Waist circumference (cm)	After intervention, Week 12
Body mass Index (BMI)		Baseline
Body mass Index (BMI)		After intervention, Week 12
Systolic Blood Pressure		Baseline
Systolic Blood Pressure		After intervention, Week 12
Diastolic Blood Pressure		Baseline
Diastolic Blood Pressure		After intervention, Week 12
Total Cholesterol		Baseline
LDL Cholesterol		Baseline
HDL Cholesterol		Baseline
serum creatinine		Baseline
Total Cholesterol		After intervention, Week 12
LDL Cholesterol		After intervention, Week 12
HDL Cholesterol		After intervention, Week 12
Serum creatinine		After intervention, Week 12
Left Ventricle mass	Doppler-echocardiograms	Baseline
Left Ventricle mass	Doppler-echocardiograms	After intervention, Week 12
Left atrial volume	Doppler-echocardiograms	Baseline
Left atrial volume	Doppler-echocardiograms	After intervention, Week 12
Doppler echocardiogram velocity ratio		Baseline
Doppler echocardiogram velocity ratio		After intervention, Week 12
CRP	Inflammatory marker	Baseline
IL6	Inflammatory marker	Baseline
TNF alpha	Inflammatory marker	Baseline
CRP	Inflammatory marker	After intervention, Week 12
IL6	Inflammatory marker	After intervention, Week 12
TNF alpha	Inflammatory marker	After intervention, Week 12
6- minute walk test	Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.	Baseline
6- minute walk test	Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.	After intervention, Week 12
Plasma nitrate		Baseline
Plasma nitrate		After intervention, Week 12

Collaborators and Investigators

• Sponsor: Wake Forest University Health Sciences
• Investigators: Principal Investigator: Claudia Campos, MD, Wake Forest University Health Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): June 1, 2022
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: October 1, 2019
• First Posted (Actual): October 2, 2019

Study Record Updates

• Last Update Posted (Actual): October 5, 2020
• Last Update Submitted That Met QC Criteria: October 1, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: HFPEF; DASH Diet; Low socioeconomic status
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: DASHF-PRE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No