Effect of Candida Rugosa Lipase on Serum Triglyceride Lowering

Summary

The primary objective of this study was to evaluate the safety and tolerability of 3 doses of fungal lipase in the treatment of adults with mildly elevated serum triglycerides. The secondary objective was to assess the efficacy of fungal lipase in reducing serum triglycerides in adults with mildly elevated serum triglycerides.

Conditions

• Hypertriglyceridemia

Interventions

DIETARY_SUPPLEMENT

Placebo

Participants were directed to consume 1 placebo capsule containing maltodextrin, three times daily, for 90 days. Subjects were directed to consume the capsules with their three largest eating occasions of the day.

DIETARY_SUPPLEMENT

Candida cylindracea lipase (225,000 FIP lipase units per day)

Participants were directed to consume 1 capsule containing lipase (75,000 FIP lipase units per capsule), three times daily, for 90 days. Subjects were directed to consume the capsules with their three largest eating occasions of the day.

DIETARY_SUPPLEMENT

Candida cylindracea lipase (450,000 FIP lipase units per day)

Participants were directed to consume 2 capsules containing lipase (75,000 FIP lipase units per capsule), three times daily, for 90 days. Subjects were directed to consume the capsules with their three largest eating occasions of the day.

DIETARY_SUPPLEMENT

Candida cylindracea lipase (675,000 FIP lipase units per day)

Participants were directed to consume 2 capsules containing lipase (112,500 FIP lipase units per capsule), three times daily, for 90 days. Subjects were directed to consume the capsules with their three largest eating occasions of the day.

Sponsors & Collaborators

• Atlantia Food Clinical Trials

  collaborator INDUSTRY

• Cork University Hospital

  collaborator OTHER

• BIO-CAT, Inc.

  lead INDUSTRY

Principal Investigators

• Fergus Shanahan, MD, PhD · Cork University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2014-03-13

Primary Completion

2014-10-06

Completion

2014-11-04

Countries

• Ireland

Study Locations