Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT05627440
NA

A SkeleTal Muscle Recovery Intervention With Dietary Protein in Heart Failure

Sponsor: Tufts Medical Center

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2023-04-24

Completion Date

2027-12-31

Last Updated

2025-11-25

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

Ensure Max Protein

Ensure Max Protein, 1 bottle daily (330 mL), 30 grams protein

DIETARY_SUPPLEMENT

Ensure Original

Ensure Original, 1 bottle daily (237 mL), 9 grams protein

Locations (2)

Tufts Medical Center

Boston, Massachusetts, United States

Cleveland Clinic

Cleveland, Ohio, United States