Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure

Sponsors

Lead Sponsor: Terry Lennie

Collaborator: Ohio State University

Source University of Kentucky
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.

Detailed Description

For a majority of patients with advanced heart failure, medical treatment is only partially effective in relieving heart failure symptoms. Therefore, it is recommended that palliative care be initiated soon after diagnosis. There is a need for complementary, nonpharmacologic interventions that could be easily implemented by health care providers to provide palliative care. Three major pathologic pathways underlying heart failure symptoms have been identified: fluid overload, inflammation, and oxidative stress. Prior research has demonstrated that three nutrients-sodium, omega-3 fatty acids, and lycopene-can alter these pathologic pathways. Clinical trials to date have only tested each nutrient individually. There is strong theoretical rationale that a combined intervention targeting all three nutrients would have substantial benefit in relieving symptoms in advanced heart failure. Therefore, the purposes of this study are 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. The aims of this placebo controlled study are 1) to determine the effects of a 6-month nutrition intervention on symptom burden (edema, shortness of air, and fatigue) and health related quality of life at 3 and 6 months, and time to heart failure rehospitalization or all-cause death over 12 months from baseline; 2) compare dietary sodium intake, inflammation, and markers of oxidative stress between the nutrition intervention group and a placebo group at 3 and 6 months; and 3) compare body weight, serum lycopene, and erythrocyte omega-3 index between the nutrition intervention group and a placebo group at 3 and 6 months. A total of 150 patients with advanced heart failure will be randomized to either the nutrition intervention or placebo group (75 per group). The nutrition intervention group will receive a theory based education and skill building intervention designed to decrease dietary sodium intake to ~2 g per day. A research nurse will make 4 home visits and one follow-up telephone call over 6 months to provide the education-skill building intervention. The intervention group will take 3 omega-3 fatty acid capsules (350 mg eicosapentaenoic acid and 50 mg docosahexaenoic acid) and consume tomato juice or other tomato-based products containing 20-25 mg of lycopene daily for six months. The placebo group will receive the same number of visits and phone calls but only general nutrition information will be provided. They will take 3 placebo capsules containing rice oil (500 mg/capsule) and consume their choice of fruit juices that do not contain lycopene daily for six months. Data will be collected in person at baseline, 3 months, and 6 months by a research assistant blinded to the group assignment. Patients will be followed for an additional 6 months by telephone to collect longer term data on symptom burden and quality of life as well as heart failure hospitalization and all-cause mortality at 9 and 12 months.

Overall Status Completed
Start Date November 2011
Completion Date January 2017
Primary Completion Date January 2017
Phase Phase 2
Study Type Interventional
Primary Outcome
Measure Time Frame
Event-Free Survival 12 months
Symptom burden baseline, 3, 6, 9, and 12 months
Quality of life baseline, 3, 6, 9, 12 months
Secondary Outcome
Measure Time Frame
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
Enrollment 150
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Sodium reduction

Description: Teaching and skill building to reduce dietary sodium

Arm Group Label: sodium reduction, omega-3, lycopene

Intervention Type: Dietary Supplement

Intervention Name: omega 3 and lycopene supplements

Description: omega-3 fatty acid supplements and juices containing lycopene

Arm Group Label: sodium reduction, omega-3, lycopene

Intervention Type: Dietary Supplement

Intervention Name: rice bran oil capsules

Description: placebo capsules

Arm Group Label: Control

Other Name: placebo

Intervention Type: Behavioral

Intervention Name: Generic dietary feedback from

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

Arm Group Label: Control

Other Name: attention control

Eligibility

Criteria:

Inclusion Criteria: - 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. Exclusion Criteria: - 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

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Terry A Lennie, PhD Principal Investigator University of Kentucky College of Nursing
Location
Facility:
University of Kentucky, College of Nursing | Lexington, Kentucky, 40536-0232, United States
Norton Health Care | Louisville, Kentucky, 40217, United States
Location Countries

United States

Verification Date

March 2017

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Kentucky

Investigator Full Name: Terry Lennie

Investigator Title: PI

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: sodium reduction, omega-3, lycopene

Type: Experimental

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

Label: Control

Type: Placebo Comparator

Description: Limited nutritional counseling, juice without lycopene, rice oil capsules

Acronym NIHFT
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov