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NCT Number: NCT04847973

Food As Medicine for Heart Failure

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.

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Key information

Conditions

Heart Failure Body Weight Body Weight Changes Cachexia Cardiovascular Diseases Heart Diseases Malnutrition Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms Signs and Symptoms Thinness Weight Loss

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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 shakes

Dietary Supplement

12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet

Primary outcomes

  1. 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)

  2. 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)

  3. 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)

  4. 6 minute walk test

    Time frame: Change from start to end of 12-week MTM period

    Strength and endurance measure

  5. Diet Satisfaction scale (DSat-28)

    Time frame: Change from start to end of 12-week MTM period

    Dietary satisfaction measure

Secondary outcomes

  1. Short Nutritional Assessment Questionnaire (SNAQ)

    Time frame: Change from start to end of 12-week MTM period

    Appetite questionnaire (score ranges 0 to 7, >/=3 indicating a severe malnutrition risk)

  2. Facilitated food recall

    Time frame: Change from start to end of 12-week MTM period

    3-day 24-hour facilitated food recall

  3. Weight

    Time frame: Change from start to end of 12-week MTM period

    Subject's body weight, measured on standing scale

Sponsors and collaborators

Lead sponsor

Tufts Medical Center

Other

Collaborators

  • Community Servings

Registry information

Acronym: FAM-HF

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Apr 19, 2021
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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