Food As Medicine for Heart Failure

NCT ID: NCT04847973

Last Updated: 2024-03-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 6 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-16
• Study Completion Date: 2023-12-31

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.

Conditions

Heart Failure; Malnutrition

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Medically-Tailored Meals (MTMs)

Intervention Type: OTHER

12 weeks of home-delivered MTMs, delivered weekly, containing food for 3 meals per day on 5 days of the week

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.

Group Type: EXPERIMENTAL

Protein supplementation shakes

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: OTHER

Protein supplementation shakes

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Community Servings

OTHER

Sponsor Role: collaborator

Tufts Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amanda Vest, MBBS MPH

Role: PRINCIPAL_INVESTIGATOR

Tufts Medical Center

Locations

Tufts Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

00001214

Identifier Type: -

Identifier Source: org_study_id