Effect of DASH Eating Pattern on Heart Failure Outcomes

NCT ID: NCT03538990

Last Updated: 2018-11-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-15
• Study Completion Date: 2019-12-31

Brief Summary

The objective of the study is to examine the effect of nutritional intake on cardiometabolic, inflammation, and physical function markers in advanced heart failure patients using a one-group pre-post test design feeding trial. Effects on hemodynamic markers will be assessed in a subsample of patients with implanted hemodynamic monitoring devices (CardioMEMS). The pre-test condition is represented by participants' self-selected diet, and the post-test condition is represented by a prescribed Dietary Approaches to Stop Hypertension (DASH) diet.

Conditions

Heart Failure NYHA Class III

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

DASH Eating Pattern

The DASH eating pattern meals prepared for study participants will strictly follow DASH meal planning guidelines published by National Heart, Lung, and Blood Institute of the National Institutes of Health. During the intervention phase of the study, all participants will exclusively consume prepared meals and provided beverages which will be delivered to participants' homes. Meals will be planned and prepared based on individual participant energy needs and dietary restrictions by a Registered Dietitian at the Georgia Clinical and Translational Science Alliance (CTSA) Bionutrition Unit located at Emory University.

Group Type: EXPERIMENTAL

DASH Eating Pattern

Intervention Type: OTHER

The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.

Interventions

DASH Eating Pattern

The DASH diet is a heart-healthy eating pattern that is focused on adequate consumption of fruits, vegetables, whole grains, low-fat dairy, fish, poultry, beans, nuts, and vegetables oils while emphasizing limited intake of foods containing saturated fat, such as fatty red meats, full-fat dairy products, and tropical oils, such as coconut, palm kernel, and palm oils, as well as sugar-sweetened beverages and sweets.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. 18+ years of age

2. English language literacy

3. Diagnosis of HF ≥ 3 months

4. Diagnosis of NYHA Class III HF (historical assessment)

5. Subjects must be stable on HF medication regimen for one month prior to study entry

6. At least 1 HF hospitalization within 24 months of enrollment

7. BNP >200 pg/ml

Exclusion Criteria

1. Subjects who have had an unplanned HF-related hospitalization within 2 months of enrollment

2. Subjects with a Glomerular Filtration Rate (GFR) <25 ml/min who are nonresponsive to diuretic therapy or who are on chronic renal dialysis

3. Subjects likely to undergo heart transplantation within 2 months of enrollment

4. Subjects with severe conditions limiting 6-month survival

5. Unavailability during scheduled data collection points

6. Cognitive impairment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emory University

OTHER

Sponsor Role: collaborator

University of Georgia

OTHER

Sponsor Role: lead

Responsible Party

Elisabeth Lilian Pia Sattler, Ph.D., B.S. Pharm

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elisabeth L Sattler, PhD, BSPharm

Role: PRINCIPAL_INVESTIGATOR

University of Georgia

Locations

University of Georgia Clinical and Translational Research Unit

Athens, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisabeth L Sattler, PhD, BSPharm

Role: CONTACT

lilian@uga.edu

706-542-1040

Facility Contacts

Kimberly Schmitz, MS

Role: primary

schmitzk@uga.edu

706-713-2721

Other Identifiers

STUDY00005216

Identifier Type: -

Identifier Source: org_study_id