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Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

NCT01733017 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2017-03-17

No results posted yet for this study

Summary

The purpose of is to test the effects of a 6-month nutrition intervention of dietary sodium reduction combined with supplementation of lycopene and omega-3 fatty acids on heart failure symptoms, health-related quality of life, and time to heart failure rehospitalization or all-cause death.

Conditions

Interventions

BEHAVIORAL

Sodium reduction

Teaching and skill building to reduce dietary sodium

DIETARY_SUPPLEMENT

omega 3 and lycopene supplements

omega-3 fatty acid supplements and juices containing lycopene

DIETARY_SUPPLEMENT

rice bran oil capsules

placebo capsules

BEHAVIORAL

Generic dietary feedback from

Provided a summary of the 3 day dietary recalls at baseline, 3 months, and 6 months

Sponsors & Collaborators

  • Ohio State University

    collaborator OTHER

  • Terry Lennie

    lead OTHER

Principal Investigators

  • Terry A Lennie, PhD · University of Kentucky College of Nursing

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2017-01-31
Completion
2017-01-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01733017 on ClinicalTrials.gov