Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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sodium reduction, omega-3, lycopene

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

Group Type EXPERIMENTAL

Sodium reduction

Intervention Type BEHAVIORAL

Teaching and skill building to reduce dietary sodium

omega 3 and lycopene supplements

Intervention Type DIETARY_SUPPLEMENT

omega-3 fatty acid supplements and juices containing lycopene

Control

Limited nutritional counseling, juice without lycopene, rice oil capsules

Group Type PLACEBO_COMPARATOR

rice bran oil capsules

Intervention Type DIETARY_SUPPLEMENT

placebo capsules

Generic dietary feedback from

Intervention Type BEHAVIORAL

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

Interventions

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Sodium reduction

Teaching and skill building to reduce dietary sodium

Intervention Type BEHAVIORAL

omega 3 and lycopene supplements

omega-3 fatty acid supplements and juices containing lycopene

Intervention Type DIETARY_SUPPLEMENT

rice bran oil capsules

placebo capsules

Intervention Type DIETARY_SUPPLEMENT

Generic dietary feedback from

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

Intervention Type BEHAVIORAL

Other Intervention Names

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placebo attention control

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No