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

Primary Purpose

Heart Failure, Heart Failure With Preserved Ejection Fraction

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
DASH Diet
Usual diet
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Heart Failure focused on measuring DASH Diet, Low socioeconomic status, HFPEF

Eligibility Criteria

60 Years - 74 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Wake Forest University Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DASH diet group

Attention Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Number of enrolled participants per week
Proportion of participants that adhere to the to intervention
Number participants that were retained in the trial

Secondary Outcome Measures

Proportion of participants that adhere to the diet

Full Information

First Posted
October 1, 2019
Last Updated
October 1, 2020
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04113291
Brief Title
Randomized Controlled Pilot Trial of DASH Feeding in Older Low Socioeconomic Adults Without Heart Failure
Acronym
DASHF
Official Title
Randomized Controlled Pilot Trial of Dietary Approached to Stop Hypertension (DASH) Feeding in Older Low Socioeconomic Adults Without Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Insufficient funding
Study Start Date
December 2021 (Anticipated)
Primary Completion Date
June 2022 (Anticipated)
Study Completion Date
June 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Failure With Preserved Ejection Fraction
Keywords
DASH Diet, Low socioeconomic status, HFPEF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DASH diet group
Arm Type
Experimental
Arm Description
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.
Arm Title
Attention Control Group
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
DASH Diet
Other Intervention Name(s)
Dietary Approaches to Stop Hypertension
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Usual diet
Intervention Description
12 weeks usual diet <2300 mg Na/day
Primary Outcome Measure Information:
Title
Number of enrolled participants per week
Time Frame
Up to week 12
Title
Proportion of participants that adhere to the to intervention
Time Frame
Up to week 12
Title
Number participants that were retained in the trial
Time Frame
Up to week 12
Secondary Outcome Measure Information:
Title
Proportion of participants that adhere to the diet
Time Frame
Up to week 12
Other Pre-specified Outcome Measures:
Title
Weight
Description
Weight (kilograms)
Time Frame
Baseline
Title
Weight
Description
Weight (kilograms)
Time Frame
After intervention, Week 12
Title
Waist circumference
Description
Waist circumference (cm)
Time Frame
Baseline
Title
Waist circumference
Description
Waist circumference (cm)
Time Frame
After intervention, Week 12
Title
Body mass Index (BMI)
Time Frame
Baseline
Title
Body mass Index (BMI)
Time Frame
After intervention, Week 12
Title
Systolic Blood Pressure
Time Frame
Baseline
Title
Systolic Blood Pressure
Time Frame
After intervention, Week 12
Title
Diastolic Blood Pressure
Time Frame
Baseline
Title
Diastolic Blood Pressure
Time Frame
After intervention, Week 12
Title
Total Cholesterol
Time Frame
Baseline
Title
LDL Cholesterol
Time Frame
Baseline
Title
HDL Cholesterol
Time Frame
Baseline
Title
serum creatinine
Time Frame
Baseline
Title
Total Cholesterol
Time Frame
After intervention, Week 12
Title
LDL Cholesterol
Time Frame
After intervention, Week 12
Title
HDL Cholesterol
Time Frame
After intervention, Week 12
Title
Serum creatinine
Time Frame
After intervention, Week 12
Title
Left Ventricle mass
Description
Doppler-echocardiograms
Time Frame
Baseline
Title
Left Ventricle mass
Description
Doppler-echocardiograms
Time Frame
After intervention, Week 12
Title
Left atrial volume
Description
Doppler-echocardiograms
Time Frame
Baseline
Title
Left atrial volume
Description
Doppler-echocardiograms
Time Frame
After intervention, Week 12
Title
Doppler echocardiogram velocity ratio
Time Frame
Baseline
Title
Doppler echocardiogram velocity ratio
Time Frame
After intervention, Week 12
Title
CRP
Description
Inflammatory marker
Time Frame
Baseline
Title
IL6
Description
Inflammatory marker
Time Frame
Baseline
Title
TNF alpha
Description
Inflammatory marker
Time Frame
Baseline
Title
CRP
Description
Inflammatory marker
Time Frame
After intervention, Week 12
Title
IL6
Description
Inflammatory marker
Time Frame
After intervention, Week 12
Title
TNF alpha
Description
Inflammatory marker
Time Frame
After intervention, Week 12
Title
6- minute walk test
Description
Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.
Time Frame
Baseline
Title
6- minute walk test
Description
Exercise capacity. 6- minute walk test (6 MWT) by the method of Guyatt 43. Percent predicted for age and gender.
Time Frame
After intervention, Week 12
Title
Plasma nitrate
Time Frame
Baseline
Title
Plasma nitrate
Time Frame
After intervention, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Campos, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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