Recruiting

DASH Eating Pattern

Sponsor:

University of Georgia

Code:

NCT03538990

Conditions

Heart Failure NYHA Class III

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

DASH Eating Pattern

Study Details

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 ID

NCT03538990

Start date

Nov 15, 2018

Status verified date

Nov, 2018

Completion date

Dec, 2019

Anticipated

Primary completion date

Sep, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

36 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Change in Cardiometabolic Marker Levels between Calibration and DASH Diet Intervention Phase [ Time Frame: Baseline, week 3, week 6 ]

Central Contacts and Locations

Central contacts

Elisabeth L Sattler, PhD, BSPharm

706-542-1040lilian@uga.edu

Locations

University of Georgia Clinical and Translational Research Unit

Recruiting

Athens, Georgia, United States, 30606

Contacts

Kimberly Schmitz, MS

706-713-2721schmitzk@uga.edu

More Information

Sponsor

University of Georgia

Last update posted

Nov 16, 2018

Last verified

Nov, 2018

Keywords

  • Nutrition
  • Dietary Approaches to Stop Hypertension
  • Cardiometabolic Outcomes
  • Pulmonary Artery Pressure
  • CardioMEMS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Georgia on 2018-11-16.