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Follistatin 344

FS-344, Activin-Binding Protein, FST344

Quick Stats
Studies 2
Trials 73
Recruiting NA INTERVENTIONAL NCT05627440

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

View on ClinicalTrials.gov Updated Dec 15, 2025

Brief Summary

Severe skeletal wasting and catabolic weight loss are highly common among patients with heart failure with reduced ejection fraction (HFrEF). This prospective randomized controlled trial will compare changes in the muscle mass in the arms and the legs (appendicular lean mass) in patients with HFrEF randomized between 3 groups of no, low- or high-dose protein supplementation. The dietary protein supplementation will be Ensure(R) products manufactured by Abbott Nutrition. The Investigators hypothesize that skeletal muscle wasting in HFrEF is promoted by neurohumoral activation of catabolic metabolism (such as GDF-15 and ActRII pathways) and can be at least partially reversed by increased dietary protein intake. It is anticipated that this study will determine whether dietary protein supplementation helps to prevent muscle wasting and will advance understanding of the GDF-15 and ActRII muscle wasting pathways.

Interventions

Name: Ensure Max Protein
Type: DIETARY_SUPPLEMENT
Description: Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein
Name: Ensure Original
Type: DIETARY_SUPPLEMENT
Description: Ensure Original, 1 bottle daily (237 mL), 9 grams protein

Primary Outcomes

Measure: Appendicular Lean Mass (ALM)
TimeFrame: 6 month study visit
Description: ALM as measured by dual X-ray absorptiometry (DXA)

Trial Information

NCT ID

NCT05627440

Status

Recruiting

Study Type

INTERVENTIONAL

Phases

NA

Sponsor

Tufts Medical Center

Last Updated

December 15, 2025

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