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

NCT04754373 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2021-12-22

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • KGK Science Inc.

    collaborator INDUSTRY

  • BIO-CAT Microbials, LLC

    lead INDUSTRY

Principal Investigators

  • David Crowley, MD · KGK Science

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-07-13
Primary Completion
2021-12-06
Completion
2021-12-06

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04754373 on ClinicalTrials.gov