What is Ensure protein studying for heart failure?

Ensure protein supplements are being studied to see if they can help prevent muscle loss in people with heart failure with reduced ejection fraction. The trial also aims to understand muscle wasting pathways related to this condition. The study is sponsored by Tufts Medical Center and evaluates different protein doses over six months.

Who may be eligible for this heart failure clinical trial?

Adults aged 18 to 100 years with heart failure and reduced heart pumping function may be eligible. Participants must be on standard heart failure treatment unless not tolerated and have recent signs of severe heart failure or muscle loss. There is no gender restriction. Please review eligibility criteria for more details.

Is there any cost to participate in this heart failure clinical trial?

Study-related care, including the protein supplements and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered.

Actively Recruiting

Phase Not Applicable

Age: 18Years - 100Years

All Genders

ID05627440

Study of Dietary Protein Supplementation to Prevent Muscle Wasting in Adults with Heart Failure Comparing No, Low, and High Protein Doses Using Ensure Products

Led by Tufts Medical Center · Updated on 2025-11-25

120

Participants Needed

Research Sites

30 weeks

Total Duration

AI-Summary

What this Trial Is About

This research aims to study muscle loss in patients with heart failure with reduced ejection fraction HFrEF, a condition where the heart does not pump blood effectively. It focuses on severe muscle wasting and weight loss common in these patients. The trial will explore whether increasing dietary protein intake can help reverse muscle loss, and it also examines biological pathways like GDF-15 and ActRII that may drive this muscle wasting. Participants will be randomly assigned to one of three groups receiving different levels of protein supplementation using Ensure products by Abbott Nutrition. One group receives a high dose of 30 grams protein daily Ensure Max Protein, another a low dose of 9 grams protein daily Ensure Original, and the third group receives no supplementation. The intervention lasts for 6 months with monitoring at 3 and 6 months. During the study, participants will have their muscle mass measured in arms and legs appendicular lean mass at 3 and 6 months. Additional assessments include handgrip strength, walking ability with a 6-minute walk test, and physical performance tests. Researchers will monitor protein intake and evaluate safety throughout the trial, which is sponsored by Tufts Medical Center and runs up to 2027.

CONDITIONS

Brief Title

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Who Can Participate

Age: 18Years - 100Years

All Genders

Eligibility Criteria

You may qualify if you...

Left ventricular ejection fraction (LVEF) 40% or less, with NYHA class II to IV symptoms or NT-proBNP greater than 300 pg/mL
Age between 18 and 100 years, inclusive
Receiving guideline-directed medical therapy for heart failure, unless contraindicated or not tolerated
Presence of at least one marker of severe heart failure within the prior 12 months, such as inotropic therapy, heart failure hospitalizations, low peak oxygen consumption, limited 6-minute walk distance, significant unintentional weight loss, moderate or severe muscle wasting, or high NT-proBNP levels

You will not qualify if you...

Pregnancy, planning to become pregnant, or women of reproductive potential unwilling to complete pregnancy testing before randomization
History of left ventricular assist device, heart transplantation, or severe kidney impairment (eGFR less than 20 mL/min/1.73 m2)
Known clinical disorders causing muscle weakness or wasting such as muscular dystrophy, mitochondrial disorders, active cancer, or severe post-stroke disability
Allergies or intolerances to milk, protein, lactose, or galactose
Weight over 350 pounds or body mass index over 40 kg/m2
Recent or planned use of obesity-dosed GLP-1 or GIP/GLP-1 agonist medications within specified timeframes

Research Team

Amanda R Vest, MBBS

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