Food As Medicine for Heart Failure (FAM-HF)

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Malnutrition
• Intervention / Treatment: Other: Medically-Tailored Meals (MTMs); Dietary supplement: Protein supplementation shakes

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 Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Amanda Vest, MBBS MPH; Phone Number: 3 617-636-8068; Email: avest@tuftsmedicalcenter.org
• Study Contact Backup: Name: Michele Esposito, MD; Email: mesposito@tuftsmedicalcenter.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 12 weeks of 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.	Other: 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
Experimental: 12 weeks of protein supplementation shakes; 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.	Dietary supplement: Protein supplementation shakes; 12 weeks of 1 bottle of Ensure Max Protein shake every day, in addition to partcipants' standard diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kansas City Cardiomyopathy Questionnaire (KCCQ)	Patient reported health measure (scale 0 to 100, higher indicates better health status)	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)	Change from start to end of 12-week MTM period
Sit-to-stand test	Lower extremity strength measure (lower time indicates greater strength)	Change from start to end of 12-week MTM period
6 minute walk test	Strength and endurance measure	Change from start to end of 12-week MTM period
Diet Satisfaction scale (DSat-28)	Dietary satisfaction measure	Change from start to end of 12-week MTM period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Short Nutritional Assessment Questionnaire (SNAQ)	Appetite questionnaire (score ranges 0 to 7, >/=3 indicating a severe malnutrition risk)	Change from start to end of 12-week MTM period
Facilitated food recall	3-day 24-hour facilitated food recall	Change from start to end of 12-week MTM period
Weight	Subject's body weight, measured on standing scale	Change from start to end of 12-week MTM period

Collaborators and Investigators

• Sponsor: Tufts Medical Center
• Collaborators: Community Servings
• Investigators: Principal Investigator: Amanda Vest, MBBS MPH, Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2021
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 7, 2021
• First Submitted That Met QC Criteria: April 12, 2021
• First Posted (Actual): April 19, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2024
• Last Update Submitted That Met QC Criteria: March 18, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: nutrition; heart failure; weight loss; malnutrition; cachexia
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Heart Failure; Malnutrition
• Other Study ID Numbers: 00001214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No