Clinical trial NCT04847973: Food As Medicine for Heart Failure
Official title: Food As Medicine for Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Malnutrition
Keywords: heart failure
malnutrition
weight loss
cachexia
nutrition
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: Community Servings
First posted: 2021-04-19
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. Systolic heart failure (left ventricular ejection fraction \</=40%), with New York Heart Association (NYHA) class II-III symptoms
2. At least one prior hospitalization in the preceding 12 months
3. Evidence of malnutrition on the Short Nutritional Assessment Questionnaire (SNAQ) screening tool for malnutrition (score of 2 or more)
4. Have a fixed address within the Metro Boston region and availability of home refrigeration to accommodate the MTM deliveries
5. Able and willing to sign study consent
6. 18 years or above
7. Not currently pregnant and not imminently planning a pregnancy

Exclusion Criteria:

1. Prior heart transplantation or implantation of a left ventricular assist device
2. Patients with a non-cardiac etiology for a skeletal muscle disorder e.g. muscular dystrophy, cancer
3. Currently pregnant or planning to become pregnant
4. Food allergy, aversion, or dietary preference that cannot be accommodated by Community Servings
5. Systolic blood pressure at screening \<90 mmHg, or heart rate \>110 bpm
6. Galactosemia

Primary outcomes:
measure: Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: Change from start to end of 12-week MTM period
measure: Handgrip strength measurement in kg
timeFrame: Change from start to end of 12-week MTM period
measure: Sit-to-stand test
timeFrame: Change from start to end of 12-week MTM period
measure: 6 minute walk test
timeFrame: Change from start to end of 12-week MTM period
measure: Diet Satisfaction scale (DSat-28)
timeFrame: Change from start to end of 12-week MTM period
Secondary outcomes:
measure: Short Nutritional Assessment Questionnaire (SNAQ)
timeFrame: Change from start to end of 12-week MTM period
measure: Facilitated food recall
timeFrame: Change from start to end of 12-week MTM period
measure: Weight
timeFrame: Change from start to end of 12-week MTM period
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Amanda Vest, MBBS MPH
role: PRINCIPAL_INVESTIGATOR
References: