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NCT05367596 · ClinicalTrials.gov registry record · NA
OPTIMIzing muScle Preservation in paTients wIth Cirrhosis
A NA study, sponsored by University of Kansas Medical Center.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
NCT05367596 is a NA study that has completed, run by University of Kansas Medical Center. The registered enrollment target is 20 participants.
The verdict
NCT05367596, a NA study, has completed, sponsored by University of Kansas Medical Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
Study Summary
Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function). This study proposes to test a specialized weight loss program Alternative-day Modified Fasting (ADMF) designed to promote weight loss and preserve skeletal muscle mass, strength, and function in patients with both Child-Pugh (CP) class A cirrhosis and obesity. This study will compare the effectiveness of the ADMF to Continuous Energy Restriction (CER) for 24-weeks. Both arms will receive a high-protein, high-BCAA diet, a late-night snack, supervised aerobic and resistance exercise, increased physical activity through self-monitoring, and group behavioral counseling. The primary aim of this trial is to evaluate the feasibility and acceptability of ADMF and CER for 6 months in patients with cirrhosis and obesity. The secondary aim is to compare changes in body composition in both diets.
Interventions
- BEHAVIORAL Physical activity
- BEHAVIORAL Continuous Energy Restriction (CER)
- BEHAVIORAL Alternate Day Modified Fasting (ADMF)
- BEHAVIORAL Group Health Education Sessions
- BEHAVIORAL Late Evening Snack
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2022-06-22 |
| Est. Completion | 2022-12-16 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05367596
The ClinicalTrials.gov registry entry for NCT05367596 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Kansas Medical Center, which has 408 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Physical activity is the first listed.
NCT05367596 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05367596 about?
NCT05367596 is a clinical study titled "OPTIMIzing muScle Preservation in paTients wIth Cirrhosis". Patients with obesity and cirrhosis benefit from weight loss but are prone to sarcopenia (loss of muscle mass, strength, and function). This study proposes to test a specialized weight loss program Alternative-day Modified Fasting (ADMF) designed to promote weight loss and preserve skeletal muscle ...
What is the current status of trial NCT05367596?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2022-06-22. Estimated completion is 2022-12-16.
What interventions are being tested in trial NCT05367596?
The interventions under investigation include: Physical activity (BEHAVIORAL), Continuous Energy Restriction (CER) (BEHAVIORAL), Alternate Day Modified Fasting (ADMF) (BEHAVIORAL), Group Health Education Sessions (BEHAVIORAL), Late Evening Snack (BEHAVIORAL).
Who is sponsoring clinical trial NCT05367596?
This trial is sponsored by University of Kansas Medical Center, which has 408 total clinical trials registered on ClinicalTrials.gov.
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