Food As Medicine for Heart Failure

NCT04847973 | Completed

• 1 other identifier: 00001214
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Failure; Malnutrition

Keywords

heart failure; malnutrition; weight loss; cachexia; nutrition

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (3)

• Short Nutritional Assessment Questionnaire (SNAQ)

  Change from start to end of 12-week MTM period

• Facilitated food recall

  Change from start to end of 12-week MTM period

• Weight

  Change from start to end of 12-week MTM period

Study Arms (2)

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.

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.

Dietary Supplement: Protein supplementation shakes

Interventions

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

12 weeks of medically-tailored meals (MTMs)

Protein supplementation shakes DIETARY_SUPPLEMENT

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

12 weeks of protein supplementation shakes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or above
• Not currently pregnant and not imminently planning a pregnancy

You may not qualify if:

• 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

Sponsors & Collaborators

• Tufts Medical Center: lead
• Community Servings: collaborator

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Heart Failure; Malnutrition; Weight Loss; Cachexia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Thinness

Study Officials

• Amanda Vest, MBBS MPH

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2021
• First Posted: April 19, 2021
• Study Start: April 16, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 19, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)