Isocaloric Navy-Bean Substitution in Adults With MASLD (NCT07730853)
Randomized Feasibility Trial of Isocaloric Navy-Bean Substitution in Adults With MASLD (Metabolic Dysfunction-Associated Steatotic Liver Disease)
🩺 Plain-English Summary (8th-Grade Level)
This study is a 24-week randomized crossover feasibility trial evaluating an isocaloric navy-bean dietary substitution in 40 adults with metabolic dysfunction-associated steatotic liver disease (MASLD) and intermediate-stage (F2-F3) fibrosis. Participants are randomized to one of two sequences-habitual diet followed by a navy-bean-rich diet, or a navy-bean-rich diet followed by habitual diet-with each 12-week phase guided by registered dietitians so that navy beans replace an equivalent caloric load without changing total energy intake. The primary aim is to establish feasibility and acceptability, measured by recruitment and retention, adherence with biomarker (plasma pipecolic-acid) concordance, and patient acceptability.
Who can join: Review the eligibility criteria below.
Location: Mount Sinai Hospital — New York, New York
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
- Dietary Supplement/Behavioral: Navy Bean-Rich Diet (OTHER)
- Habitual Diet (Control) (OTHER)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- Mount Sinai Hospital — New York, New York
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
- A Phase 2a Study of ALN-PNP With and Without a GLP1R Agonist in Adult Patients With Homozygous PNPLA3-Related MASLD — Coronado, California
- Fibrosis Lessens After Metabolic Surgery — Phoenix, Arizona
- Stimulating Fat Tissue Storage With Niacin to Reduce Fat Accumulation in the Liver. — Sherbrooke, Quebec
Explore by condition: All Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD) clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.