Nutritional Therapy for Autonomic Dysfunction in Elderly Heart Failure Patients
1 other identifier
interventional
21
1 country
1
Brief Summary
Recent studies suggest that patients with heart failure (HF) may have a reduced ability to control the tone of their blood vessels, heart rate or blood pressure in response to stress. This study will test whether 16 weeks of protein supplements can improve control of blood pressure and heart rate in HF patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jul 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2018
CompletedFirst Submitted
Initial submission to the registry
February 2, 2024
CompletedFirst Posted
Study publicly available on registry
February 13, 2024
CompletedFebruary 13, 2024
January 1, 2024
1.5 years
February 2, 2024
February 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Cardiovascular assessment of blood pressure
Measuring orthostatic blood pressure
Change from baseline to 16 weeks
Cardiovascular assessment
Measuring heart rate before and after intervention
Change from baseline to 16 weeks
Study Arms (2)
Whey protein powder and L-carnitine capsules
EXPERIMENTALSubjects will daily consume whey protein powder to supplement normal daily protein intake up to 1.2g protein/kg body weight per day (1 or 2 scoops powder), as well as 2 capsules (1 gram) L-carnitine for 16 weeks.
Maltodextrin placebo powder and Psyllium Husk capsules
PLACEBO COMPARATORSubjects will daily consume maltodextrin powder as if to supplement normal daily protein intake up to 1.2g protein/kg body weight per day (1 or 2 scoops powder), as well as 2 capsules (1 gram) psyllium husk for 16 weeks.
Interventions
Dietary supplement intervention for 16 weeks
Maltodextrin placebo powder and Psyllium Husk capsules
Eligibility Criteria
You may qualify if:
- Mild to moderate heart failure (NYHA I, II, or III symptomology) as confirmed by study physician
You may not qualify if:
- Moderately-severe dementia (MoCA score)
- Active inflammatory bowel disease
- Active cancer or chemotherapy in the past year
- Self-reported allergy to whey protein
- Documented insulin-dependent diabetes mellitus, or uncontrolled diabetes with hemoglobin A1C \>8.5% (collected from medical record)
- \>50mg doses of metoprolol or atenolol daily or more than 12.5mg twice daily of carvedilol
- History of renal failure stage IV or V
- History of severe orthostasis (\>20mm Hg drop in systolic pressure)
- History of high grade second degree heart block
- History of arrhythmias (atrial or ventricular, tachy or brady)
- Other criteria as determined by the study physician
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gohar Azhar, M.D.
University of Arkansas
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2024
First Posted
February 13, 2024
Study Start
July 26, 2016
Primary Completion
January 11, 2018
Study Completion
February 1, 2018
Last Updated
February 13, 2024
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share