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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-31

Study Completion Date

2022-06-30

Brief Summary

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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.

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Detailed Description

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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).

Conditions

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Heart Failure Heart Failure With Preserved Ejection Fraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DASH Diet

Intervention Type OTHER

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.

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.

Group Type ACTIVE_COMPARATOR

Usual diet

Intervention Type OTHER

12 weeks usual diet \<2300 mg Na/day

Interventions

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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.

Intervention Type OTHER

Usual diet

12 weeks usual diet \<2300 mg Na/day

Intervention Type OTHER

Other Intervention Names

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Dietary Approaches to Stop Hypertension

Eligibility Criteria

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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

Minimum Eligible Age

60 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes