Heart FailurePhase 2NIHFTNCT01733017
Nutrition Intervention to Decrease Symptoms in Patients With Heart Failure
A Phase 2 study testing Sodium reduction, omega 3 and lycopene supplements and rice bran oil capsules in people with Heart Failure, run by Terry Lennie at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Sodium reduction, omega 3 and lycopene supplements and rice bran oil capsules
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2011to Jan 2017
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Kentucky, College of Nursing
Lexington, Kentucky, 40536-0232
Norton Health Care
Louisville, Kentucky, 40217
About this study
Official title: Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure
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.
Read the 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.
- Conditions
- Heart Failure
- Being tested
- Sodium reduction, omega 3 and lycopene supplements, rice bran oil capsules, Generic dietary feedback from
- Keywords
- heart failure, nutrition therapy, symptoms, quality of life, lycopene, omega-3 fatty acids
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium reductionBehavioural
Teaching and skill building to reduce dietary sodium
omega 3 and lycopene supplementsDietary supplement
omega-3 fatty acid supplements and juices containing lycopene
rice bran oil capsulesDietary supplement
Also called placebo
placebo capsules
Generic dietary feedback fromBehavioural
Also called attention control
Provided a summary of the 3 day dietary recalls at baseline, 3 months, and 6 months
| Study group | Role | What they receive |
|---|---|---|
| sodium reduction, omega-3, lycopene | Experimental | combination of dietary sodium restriction with supplementation of omega-3 capsules and lycopene containing juices or foods Receives: Behavioral: Sodium reduction; Dietary Supplement: omega 3 and lycopene supplements |
| Control | Placebo comparator | Limited nutritional counseling, juice without lycopene, rice oil capsules Receives: Dietary Supplement: rice bran oil capsules; Behavioral: Generic dietary feedback from |
What is being measured
The primary outcome is the main question the study is designed to answer.
Event-Free Survival
Combined endpoint of cardiac-related hospitalization and all cause mortality
Measured: 12 months
Symptom burden
combined score of symptom severity, frequency, and distress for common symptoms of heart failure
Measured: baseline, 3, 6, 9, and 12 months
Quality of life
heart failure related quality of life
Measured: baseline, 3, 6, 9, 12 months
Secondary outcomes (5)
omega-3 index
the ratio of EPA plus DHA as a percentage of total fatty acids in the cell membrane of erythrocytes
Measured: baseline, 3, 6, 9, 12 months
oxidative stress
serum levels of malondialdehyde and 8-iso-PGF2a isoprostane will serve as markers of increased lipid peroxidation due to oxygen free radical production exceeding antioxidant capacity
Measured: baseline, 3, 6, 9, 12 months
Inflammation
Serum levels of tumor necrosis factor-alpha (TNFα), soluble TNF receptors: sTNFR1 and sTNFR2 will be measured as markers of proinflammatory cytokine activity; interleukin-10 (IL-10) will be measured as a marker of anti-inflammatory cytokine activity
Measured: baseline, 3, 6, 9, 12 months
Lycopene
Plasma lycopene will be measured as a marker intervention effectiveness
Measured: baseline, 3, 6, 9, 12 months
Sodium intake
Three 24-hour diet recall interviews at each timepoint will be used estimate sodium intake and to identify high sodium foods and eating patterns for the sodium reduction component of the intervention.
Measured: baseline, 3, 6, 9, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study startNov 2011
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Terry Lennie
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University
- Responsible party
- Sponsor-investigator, Terry Lennie, University of Kentucky
- Investigators
- Terry A Lennie, PhD, Principal investigator, University of Kentucky College of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733017
- Sponsor's protocol ID
- R01NR013430
- Acronym
- NIHFT
- Status last verified
- Mar 2017
- First submitted
- 15 Nov 2012
- Last updated
- 17 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutrition Intervention to Reduce Symptoms in Patients With Advanced Heart Failure
- ClinicalTrials.gov ID
- NCT01733017
- Acronym / sponsor ID
- NIHFT / R01NR013430
- Conditions
- Heart Failure
- Keywords
- heart failure, nutrition therapy, symptoms, quality of life, lycopene, omega-3 fatty acids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Terry LennieUniversity, hospital or other
- Collaborators
- Ohio State University
- Study start
- Nov 2011
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sodium reduction, omega-3, lycopene | Experimental | Behavioral: Sodium reduction, Dietary Supplement: omega 3 and lycopene supplementscombination of dietary sodium restriction with supplementation of omega-3 capsules and lycopene containing juices or foods |
| Control | Placebo comparator | Dietary Supplement: rice bran oil capsules, Behavioral: Generic dietary feedback fromLimited nutritional counseling, juice without lycopene, rice oil capsules |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sodium reductionTeaching and skill building to reduce dietary sodium | Behavioural | sodium reduction, omega-3, lycopene |
| omega 3 and lycopene supplementsomega-3 fatty acid supplements and juices containing lycopene | Dietary supplement | sodium reduction, omega-3, lycopene |
| rice bran oil capsulesAlso: placeboplacebo capsules | Dietary supplement | Control |
| Generic dietary feedback fromAlso: attention controlProvided a summary of the 3 day dietary recalls at baseline, 3 months, and 6 months | Behavioural | Control |
Primary outcome
Event-Free Survival
Time frame: 12 months
Combined endpoint of cardiac-related hospitalization and all cause mortality
Symptom burden
Time frame: baseline, 3, 6, 9, and 12 months
combined score of symptom severity, frequency, and distress for common symptoms of heart failure
Quality of life
Time frame: baseline, 3, 6, 9, 12 months
heart failure related quality of life
5 secondary outcomes
omega-3 index
Time frame: baseline, 3, 6, 9, 12 months
oxidative stress
Time frame: baseline, 3, 6, 9, 12 months
Inflammation
Time frame: baseline, 3, 6, 9, 12 months
Lycopene
Time frame: baseline, 3, 6, 9, 12 months
Sodium intake
Time frame: baseline, 3, 6, 9, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Terry A Lennie, PhD principal investigator
University of Kentucky College of Nursing
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sodium reduction, omega 3 and lycopene supplements and rice bran oil capsules in people with Heart Failure, run by Terry Lennie at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Event-Free Survival (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2017.