NCT01733017

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for phase_2 heart-failure

Timeline
Completed

Started Nov 2011

Longer than P75 for phase_2 heart-failure

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

November 15, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

5.2 years

First QC Date

November 15, 2012

Last Update Submit

March 15, 2017

Conditions

Heart Failure

Keywords

heart failurenutrition therapysymptomsquality of lifelycopeneomega-3 fatty acids

Outcome Measures

Primary Outcomes (3)

  • Event-Free Survival

    Combined endpoint of cardiac-related hospitalization and all cause mortality

    12 months

  • Symptom burden

    combined score of symptom severity, frequency, and distress for common symptoms of heart failure

    baseline, 3, 6, 9, and 12 months

  • Quality of life

    heart failure related quality of life

    baseline, 3, 6, 9, 12 months

Secondary Outcomes (5)

  • omega-3 index

    baseline, 3, 6, 9, 12 months

  • oxidative stress

    baseline, 3, 6, 9, 12 months

  • Inflammation

    baseline, 3, 6, 9, 12 months

  • Lycopene

    baseline, 3, 6, 9, 12 months

  • Sodium intake

    baseline, 3, 6, 9, 12 months

Study Arms (2)

sodium reduction, omega-3, lycopene

EXPERIMENTAL

combination of dietary sodium restriction with supplementation of omega-3 capsules and lycopene containing juices or foods

Behavioral: Sodium reductionDietary Supplement: omega 3 and lycopene supplements

Control

PLACEBO COMPARATOR

Limited nutritional counseling, juice without lycopene, rice oil capsules

Dietary Supplement: rice bran oil capsulesBehavioral: Generic dietary feedback from

Interventions

Sodium reductionBEHAVIORAL

Teaching and skill building to reduce dietary sodium

sodium reduction, omega-3, lycopene
omega 3 and lycopene supplementsDIETARY_SUPPLEMENT

omega-3 fatty acid supplements and juices containing lycopene

sodium reduction, omega-3, lycopene
rice bran oil capsulesDIETARY_SUPPLEMENT

placebo capsules

Also known as: placebo
Control
Generic dietary feedback fromBEHAVIORAL

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

Also known as: attention control
Control

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • chronic heart failure with either preserved or non-preserved ejection fraction
  • for chronic heart failure, have undergone evaluation of heart failure and optimization of medical therapy, for patients discharged from hospital for acute/newly diagnosed heart failure, have undergone evaluation of heart failure and optimization of medical therapy for at least 1 month post discharge
  • New York Heart Association functional classification of II, III or IV
  • have not been referred for heart transplantation
  • able to read and speak English
  • no cognitive impairment that precludes giving informed consent or ability to follow protocol instruction.

You may not qualify if:

  • BMI \< 17 kg/m2 or \> 46 kg/m2
  • co-existing illness documented in the medical record known to be associated with systemic inflammation decreased appetite or absorption, fatigue, edema, or weight loss
  • currently taking dietary supplements that contain lycopene or omega-3 fatty acids
  • allergy to rice bran oil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Kentucky, College of Nursing

Lexington, Kentucky, 40536-0232, United States

Location

Norton Health Care

Louisville, Kentucky, 40217, United States

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Docosahexaenoic AcidsRice Bran Oil

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Fatty Acids, Omega-3Dietary Fats, UnsaturatedDietary FatsFatsLipidsFatty Acids, UnsaturatedFatty AcidsFish OilsOilsFats, UnsaturatedPlant OilsPlant PreparationsBiological ProductsComplex Mixtures

Study Officials

  • Terry A Lennie, PhD

    University of Kentucky College of Nursing

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
PI

Study Record Dates

First Submitted

November 15, 2012

First Posted

November 26, 2012

Study Start

November 1, 2011

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

March 17, 2017

Record last verified: 2017-03

Locations

US(2)