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

October 1, 2020 updated by: Wake Forest University Health Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of enrolled participants per week
Time Frame: Up to week 12
Up to week 12
Proportion of participants that adhere to the to intervention
Time Frame: Up to week 12
Up to week 12
Number participants that were retained in the trial
Time Frame: Up to week 12
Up to week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of participants that adhere to the diet
Time Frame: Up to week 12
Up to week 12

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Weight
Time Frame: Baseline
Weight (kilograms)
Baseline
Weight
Time Frame: After intervention, Week 12
Weight (kilograms)
After intervention, Week 12
Waist circumference
Time Frame: Baseline
Waist circumference (cm)
Baseline
Waist circumference
Time Frame: After intervention, Week 12
Waist circumference (cm)
After intervention, Week 12
Body mass Index (BMI)
Time Frame: Baseline
Baseline
Body mass Index (BMI)
Time Frame: After intervention, Week 12
After intervention, Week 12
Systolic Blood Pressure
Time Frame: Baseline
Baseline
Systolic Blood Pressure
Time Frame: After intervention, Week 12
After intervention, Week 12
Diastolic Blood Pressure
Time Frame: Baseline
Baseline
Diastolic Blood Pressure
Time Frame: After intervention, Week 12
After intervention, Week 12
Total Cholesterol
Time Frame: Baseline
Baseline
LDL Cholesterol
Time Frame: Baseline
Baseline
HDL Cholesterol
Time Frame: Baseline
Baseline
serum creatinine
Time Frame: Baseline
Baseline
Total Cholesterol
Time Frame: After intervention, Week 12
After intervention, Week 12
LDL Cholesterol
Time Frame: After intervention, Week 12
After intervention, Week 12
HDL Cholesterol
Time Frame: After intervention, Week 12
After intervention, Week 12
Serum creatinine
Time Frame: After intervention, Week 12
After intervention, Week 12
Left Ventricle mass
Time Frame: Baseline
Doppler-echocardiograms
Baseline
Left Ventricle mass
Time Frame: After intervention, Week 12
Doppler-echocardiograms
After intervention, Week 12
Left atrial volume
Time Frame: Baseline
Doppler-echocardiograms
Baseline
Left atrial volume
Time Frame: After intervention, Week 12
Doppler-echocardiograms
After intervention, Week 12
Doppler echocardiogram velocity ratio
Time Frame: Baseline
Baseline
Doppler echocardiogram velocity ratio
Time Frame: After intervention, Week 12
After intervention, Week 12
CRP
Time Frame: Baseline
Inflammatory marker
Baseline
IL6
Time Frame: Baseline
Inflammatory marker
Baseline
TNF alpha
Time Frame: Baseline
Inflammatory marker
Baseline
CRP
Time Frame: After intervention, Week 12
Inflammatory marker
After intervention, Week 12
IL6
Time Frame: After intervention, Week 12
Inflammatory marker
After intervention, Week 12
TNF alpha
Time Frame: After intervention, Week 12
Inflammatory marker
After intervention, Week 12
6- minute walk test
Time Frame: Baseline
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
Time Frame: After intervention, Week 12
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
Time Frame: Baseline
Baseline
Plasma nitrate
Time Frame: After intervention, Week 12
After intervention, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Wake Forest University Health Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Claudia Campos, MD, Wake Forest University Health Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 1, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 5, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 1, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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