NCT04754373

A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride

A Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: BIO-CAT Microbials, LLC · Industry
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Accepted

Summary

In this study, a lipase -sourced from a nonpyrogenic yeast, Candida rugosa, will be investigated to establish optimal TG levels in adults in a 12-week supplementation period. The investigational product provides a lipase formulation that is stable and active in acidic and neutral pH environments, while also fully digesting TGs into free fatty acids and glycerol which is beyond the scope of pancreatic lipase (Schuler et al. 2012). This will be a novel study investigating the effects of C. rugosa lipase on adults with slightly elevated TG levels.

Conditions

• Elevated Triglycerides

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GFA-918	Participants will be instructed to take one GFA-918 (125000 FIP Units of Lipase AY) capsule twice per day with their morning and evening meals for 12 weeks.
OTHER	Placebo	Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Timeline

• Start date: 2018-07-13
• Primary completion: 2021-12-06
• Completion: 2021-12-06
• First posted: 2021-02-15
• Last updated: 2021-12-22

Locations

2 sites across 1 country: Canada