Heart FailureFAM-HFNCT04847973
Food As Medicine for Heart Failure
A study testing Medically-Tailored Meals (MTMs) and Protein supplementation shakes in people with Heart Failure and Malnutrition, run by Tufts Medical Center at 1 site in United States.
Trial summary
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Malnutrition
- What is being tested?
- Medically-Tailored Meals (MTMs) and Protein supplementation shakes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2021to 31 Dec 2023
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms
- At least one prior hospitalization in the preceding 12 months
- Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
- Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
- Able and willing to sign study consent
- 18 years or above
- Not currently pregnant and not imminently planning a pregnancy
Who cannot join
- Prior heart transplantation or implantation of a left ventricular assist device
- Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer
- Currently pregnant or planning to become pregnant
- Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
- Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm
- Galactosemia
Trial locations and contacts
1 site in 1 country.
About this study
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of 'food as medicine' to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) or protein supplementation shakes to patients with HFrEF and malnutrition. The investigators hypothesize that home delivery of MTMs or protein supplementation shakes will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The current pilot phase is a single arm non-randomized study. An initial phase has delivered a 12-week MTM dietary intervention. The MTMs are designed, prepared and delivered by our community based organized partner, Community Servings. A second phase will deliver a 12-week protein supplementation shake intervention, with 1 bottle to be consumed daily in addition to the participants' standard home diet. The investigators will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of nutritional intervention for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
Read the detailed description
We plan to conduct a single-center pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals to patients with heart failure with reduced ejection fraction and malnutrition. We hypothesize that a nutritionally complete meal plan, targeting 1.1-1.5 g/kg/day protein intake, will improve symptomatology, functional capacity, and serum biomarkers of heart failure in this patient population. We have two primary objectives for this pilot study: 1) confirm tolerability, feasibility, and efficacy of prescribing MTMs or oral protein supplementation and 2) measure changes in functional capacity, patient-reported health status, and biomarkers of nutritional status and heart failure over the course of the study period. For this proposed study, we will test the following elements of this central hypothesis with 2 aims:
Aim 1 Tolerability, feasibility, and efficacy of prescribing medically-tailored meals or protein supplementation: Tolerability will be assessed with the validated 28-item dietary satisfaction score (DSat-28). Efficacy will be assessed by improvement in patient-reported health status questionnaires and feasibility will be assessed by the macronutrient intakes achieved on facilitated food recalls.
Aim 2 Functional capacity and serum biomarkers of nutrition/heart failure: Determine whether medically tailored meals improve symptomatology, functional capacity, and serum biomarkers of nutrition and heart failure in patients with advanced heart failure.
- Conditions
- Heart Failure, Malnutrition
- Being tested
- Medically-Tailored Meals (MTMs), Protein supplementation shakes
- Keywords
- heart failure, malnutrition, weight loss, cachexia, nutrition
- Medical subject headings
- Heart Failure, Malnutrition, Weight Loss, Cachexia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medically-Tailored Meals (MTMs)Other
12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week
Protein supplementation shakesDietary supplement
12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet
| Study group | Role | What they receive |
|---|---|---|
| 12 weeks of medically-tailored meals (MTMs) | Experimental | 12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day. Receives: Other: Medically-Tailored Meals (MTMs) |
| 12 weeks of protein supplementation shakes | Experimental | Participants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery. Receives: Dietary Supplement: Protein supplementation shakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Patient reported health measure (scale 0 to 100, higher indicates better health status)
Measured: Change from start to end of 12-week MTM period
Handgrip strength measurement in kg
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Measured: Change from start to end of 12-week MTM period
Sit-to-stand test
Lower extremity strength measure (lower time indicates greater strength)
Measured: Change from start to end of 12-week MTM period
6 minute walk test
Strength and endurance measure
Measured: Change from start to end of 12-week MTM period
Diet Satisfaction scale (DSat-28)
Dietary satisfaction measure
Measured: Change from start to end of 12-week MTM period
Secondary outcomes (3)
Short Nutritional Assessment Questionnaire (SNAQ)
Appetite questionnaire (score ranges 0 to 7, >/=3 indicating a severe malnutrition risk)
Measured: Change from start to end of 12-week MTM period
Facilitated food recall
3-day 24-hour facilitated food recall
Measured: Change from start to end of 12-week MTM period
Weight
Subject's body weight, measured on standing scale
Measured: Change from start to end of 12-week MTM period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start16 Apr 2021
- Primary completion31 Dec 2023
- Study completion31 Dec 2023
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Community Servings
- Responsible party
- Sponsor
- Investigators
- Amanda Vest, MBBS MPH, Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847973
- Sponsor's protocol ID
- 00001214
- Acronym
- FAM-HF
- Status last verified
- Mar 2024
- First submitted
- 7 Apr 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Food As Medicine for Heart Failure
- ClinicalTrials.gov ID
- NCT04847973
- Acronym / sponsor ID
- FAM-HF / 00001214
- Conditions
- Heart Failure, Malnutrition
- Keywords
- heart failure, malnutrition, weight loss, cachexia, nutrition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Tufts Medical CenterUniversity, hospital or other
- Collaborators
- Community Servings
- Study start
- 16 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 19 Apr 2021 (actual)
- 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.
Malnutrition and unintentional weight loss are highly prevalent among patients with heart failure (HF), with approximately 50% of patients with heart failure meeting malnutrition criteria. Poor dietary quality and micronutrient deficiencies are associated with higher rates of HF hospitalization and mortality. Therefore nutritional interventions to improve dietary quality and prevent malnutrition development may represent an effective strategy to improve HF-related health status and survival outcomes. To date, there are no large clinical trials investigating the efficacy of 'food as medicine' to improve morbidity and mortality for patients with heart failure with reduced ejection fraction (HFrEF). The investigators plan to conduct a single-center, randomized pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals (MTMs) or protein supplementation shakes to patients with HFrEF and malnutrition. The investigators hypothesize that home delivery of MTMs or protein supplementation shakes will be feasible, well-tolerated and achieve a high degree of satisfaction for patients with HFrEF. The current pilot phase is a single arm non-randomized study. An initial phase has delivered a 12-week MTM dietary intervention. The MTMs are designed, prepared and delivered by our community based organized partner, Community Servings. A second phase will deliver a 12-week protein supplementation shake intervention, with 1 bottle to be consumed daily in addition to the participants' standard home diet. The investigators will measure HF-related health status, functional capacity, and biomarkers of heart failure and nutritional status before and after each study phase. The proposed study will facilitate a larger future randomized trial of nutritional intervention for patients with HFrEF and malnutrition, powered to examine the impact on HF hospitalizations and mortality.
Detailed description
We plan to conduct a single-center pilot trial to assess the tolerability, feasibility, and efficacy of providing medically-tailored meals to patients with heart failure with reduced ejection fraction and malnutrition. We hypothesize that a nutritionally complete meal plan, targeting 1.1-1.5 g/kg/day protein intake, will improve symptomatology, functional capacity, and serum biomarkers of heart failure in this patient population. We have two primary objectives for this pilot study: 1) confirm tolerability, feasibility, and efficacy of prescribing MTMs or oral protein supplementation and 2) measure changes in functional capacity, patient-reported health status, and biomarkers of nutritional status and heart failure over the course of the study period. For this proposed study, we will test the following elements of this central hypothesis with 2 aims:
Aim 1 Tolerability, feasibility, and efficacy of prescribing medically-tailored meals or protein supplementation: Tolerability will be assessed with the validated 28-item dietary satisfaction score (DSat-28). Efficacy will be assessed by improvement in patient-reported health status questionnaires and feasibility will be assessed by the macronutrient intakes achieved on facilitated food recalls.
Aim 2 Functional capacity and serum biomarkers of nutrition/heart failure: Determine whether medically tailored meals improve symptomatology, functional capacity, and serum biomarkers of nutrition and heart failure in patients with advanced heart failure.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 12 weeks of medically-tailored meals (MTMs) | Experimental | Other: Medically-Tailored Meals (MTMs)12 weeks of home-delivered medically-tailored meals (MTMs), prepared and delivered by the non-profit Community Servings. The MTM has be developed specifically for patients with heart failure, with an approximate protein intake range of 1.1-1.5 g/kg body weight/day and a maximum of 2000 mg sodium/day. |
| 12 weeks of protein supplementation shakes | Experimental | Dietary Supplement: Protein supplementation shakesParticipants will receive 1 bottle of Ensure Max Protein shake every day (any flavor option without caffeine, daily for 12 weeks) to take in addition to their standard diet, without MTM delivery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Systolic heart failure (left ventricular ejection fraction </=40%), with New York Heart Association (NYHA) class II-III symptoms
- At least one prior hospitalization in the preceding 12 months
- Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
- Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
- Able and willing to sign study consent
Key exclusion criteria (6 listed)
- Prior heart transplantation or implantation of a left ventricular assist device
- Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer
- Currently pregnant or planning to become pregnant
- Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
- Systolic blood pressure at screening <90 mmHg, or heart rate >110 bpm
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 |
|---|---|---|
| Medically-Tailored Meals (MTMs)12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week | Other | 12 weeks of medically-tailored meals (MTMs) |
| Protein supplementation shakes12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet | Dietary supplement | 12 weeks of protein supplementation shakes |
Primary outcome
Kansas City Cardiomyopathy Questionnaire (KCCQ)
Time frame: Change from start to end of 12-week MTM period
Patient reported health measure (scale 0 to 100, higher indicates better health status)
Handgrip strength measurement in kg
Time frame: Change from start to end of 12-week MTM period
Upper extremity strength measured by dynamometer (higher kg achieved indicates greater strength)
Sit-to-stand test
Time frame: Change from start to end of 12-week MTM period
Lower extremity strength measure (lower time indicates greater strength)
6 minute walk test
Time frame: Change from start to end of 12-week MTM period
Strength and endurance measure
Diet Satisfaction scale (DSat-28)
Time frame: Change from start to end of 12-week MTM period
Dietary satisfaction measure
3 secondary outcomes
Short Nutritional Assessment Questionnaire (SNAQ)
Time frame: Change from start to end of 12-week MTM period
Facilitated food recall
Time frame: Change from start to end of 12-week MTM period
Weight
Time frame: Change from start to end of 12-week MTM period
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 19 Mar 2024.
- Individual participant dataSharing planned: No
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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.
Amanda Vest, MBBS MPH principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medically-Tailored Meals (MTMs) and Protein supplementation shakes in people with Heart Failure and Malnutrition, run by Tufts Medical Center at 1 site 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 7 inclusion and 6 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 19 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Kansas City Cardiomyopathy Questionnaire (KCCQ) (time frame: Change from start to end of 12-week MTM period). The study lists 5 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 19 Mar 2024.