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

Heart Failure Clinical Trial

— DASHF  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04113291
• Other study ID #: DASHF-PRE
• Status: Withdrawn
• Phase: N/A
• Start date: December 2021
• Est. completion date: June 2022

Study information

• Verified date: October 2020
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure
• Heart Failure With Preserved Ejection Fraction

Intervention

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.
• Usual diet
12 weeks usual diet <2300 mg Na/day

Locations

Country	Name	City	State
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Weight	Weight (kilograms)	Baseline
Other	Weight	Weight (kilograms)	After intervention, Week 12
Other	Waist circumference	Waist circumference (cm)	Baseline
Other	Waist circumference	Waist circumference (cm)	After intervention, Week 12
Other	Body mass Index (BMI)		Baseline
Other	Body mass Index (BMI)		After intervention, Week 12
Other	Systolic Blood Pressure		Baseline
Other	Systolic Blood Pressure		After intervention, Week 12
Other	Diastolic Blood Pressure		Baseline
Other	Diastolic Blood Pressure		After intervention, Week 12
Other	Total Cholesterol		Baseline
Other	LDL Cholesterol		Baseline
Other	HDL Cholesterol		Baseline
Other	serum creatinine		Baseline
Other	Total Cholesterol		After intervention, Week 12
Other	LDL Cholesterol		After intervention, Week 12
Other	HDL Cholesterol		After intervention, Week 12
Other	Serum creatinine		After intervention, Week 12
Other	Left Ventricle mass	Doppler-echocardiograms	Baseline
Other	Left Ventricle mass	Doppler-echocardiograms	After intervention, Week 12
Other	Left atrial volume	Doppler-echocardiograms	Baseline
Other	Left atrial volume	Doppler-echocardiograms	After intervention, Week 12
Other	Doppler echocardiogram velocity ratio		Baseline
Other	Doppler echocardiogram velocity ratio		After intervention, Week 12
Other	CRP	Inflammatory marker	Baseline
Other	IL6	Inflammatory marker	Baseline
Other	TNF alpha	Inflammatory marker	Baseline
Other	CRP	Inflammatory marker	After intervention, Week 12
Other	IL6	Inflammatory marker	After intervention, Week 12
Other	TNF alpha	Inflammatory marker	After intervention, Week 12
Other	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
Other	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
Other	Plasma nitrate		Baseline
Other	Plasma nitrate		After intervention, Week 12
Primary	Number of enrolled participants per week		Up to week 12
Primary	Proportion of participants that adhere to the to intervention		Up to week 12
Primary	Number participants that were retained in the trial		Up to week 12
Secondary	Proportion of participants that adhere to the diet		Up to week 12