Effect of Candida Rugosa Lipase on Serum Triglyceride Lowering

NCT05295134 | Completed

• 1 other identifier: AFCRO-047
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

triglyceride; lipase; cholesterol; cylindracea; rugosa; digestion; triacylglycerol

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability: Adverse events

  Self-reported adverse events at Visits 1, 2, and 3

  90 days

Secondary Outcomes (22)

• The change in levels of fasting serum triglycerides

  90 days

• The change in blood levels of fasting cholesterol

  90 days

• Safety: Glycated hemoglobin A1C (HbA1C)

  90 days

• Safety: Glucose

  90 days

• Safety: Alanine aminotransferase (ALT)

  90 days

Study Arms (4)

Placebo

PLACEBO COMPARATOR

Maltodextrin

Dietary Supplement: Placebo

Lipase: Low-Dose

ACTIVE COMPARATOR

Candida cylindracea lipase (75,000 FIP per serving)

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

Lipase: Medium-Dose

ACTIVE COMPARATOR

Candida cylindracea lipase (150,000 FIP per serving)

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

Lipase: High-Dose

ACTIVE COMPARATOR

Candida cylindracea lipase (225,000 FIP per serving)

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

Interventions

Placebo DIETARY_SUPPLEMENT

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.

Placebo

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

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.

Also known as: GFA-918, Candida rugosa lipase

Lipase: Low-Dose

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

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.

Also known as: GFA-918, Candida rugosa lipase

Lipase: Medium-Dose

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

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.

Also known as: GFA-918, Candida rugosa lipase

Lipase: High-Dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Be able to give written informed consent
• Be between 18 and 75 years of age
• Be in generally good health as determined by the investigator
• Serum triglyceride levels between 151 mg/dL (1.71 mmol/L) and 499 mg/dL (5.65 mmol/L)

You may not qualify if:

• Are less than 18 and greater than 75 years of age
• Females are pregnant, lactating or wish to become pregnant during the study
• Are hypersensitive to any of the components of the test product,
• Have a significant acute or chronic, unstable and untreated disease or any condition which contraindicates, in the investigator's judgement, entry to the study
• Have an active gastrointestinal disorder or previous gastrointestinal surgery
• Have a known family history of hyperlipidemia
• Having a condition or have taken a medication or supplement that the investigator believes would interfere with the objectives of the study, pose a safety risk or confound the interpretation of the study results, including triglyceride lowering medications (e.g., fibrates and statins) and supplements (e.g., plant sterols/stanols, fish oil supplements, and vitamin B complex supplements)
• Have not made any major dietary changes in the past 3 months
• History of illicit drug use
• Subjects who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the trial
• Subjects may not be receiving treatment involving experimental drugs
• If the subject has participated in a recent experimental trial, the trial must have been completed not less than 60 days prior to this study
• Have a malignant disease or any concomitant end-stage organ disease

Sponsors & Collaborators

• BIO-CAT, Inc.: lead
• Atlantia Food Clinical Trials: collaborator
• Cork University Hospital: collaborator

Study Sites (1)

Atlantia Food Clinical Trials, Western Gateway Bldg, University College Cork

Cork, Co. Cork, T12 XF62, Ireland

Location

Related Publications (2)

• Varbo A, Nordestgaard BG, Tybjaerg-Hansen A, Schnohr P, Jensen GB, Benn M. Nonfasting triglycerides, cholesterol, and ischemic stroke in the general population. Ann Neurol. 2011 Apr;69(4):628-34. doi: 10.1002/ana.22384. Epub 2011 Feb 18.

  PMID: 21337605 BACKGROUND

• Virani SS, Alonso A, Benjamin EJ, Bittencourt MS, Callaway CW, Carson AP, Chamberlain AM, Chang AR, Cheng S, Delling FN, Djousse L, Elkind MSV, Ferguson JF, Fornage M, Khan SS, Kissela BM, Knutson KL, Kwan TW, Lackland DT, Lewis TT, Lichtman JH, Longenecker CT, Loop MS, Lutsey PL, Martin SS, Matsushita K, Moran AE, Mussolino ME, Perak AM, Rosamond WD, Roth GA, Sampson UKA, Satou GM, Schroeder EB, Shah SH, Shay CM, Spartano NL, Stokes A, Tirschwell DL, VanWagner LB, Tsao CW; American Heart Association Council on Epidemiology and Prevention Statistics Committee and Stroke Statistics Subcommittee. Heart Disease and Stroke Statistics-2020 Update: A Report From the American Heart Association. Circulation. 2020 Mar 3;141(9):e139-e596. doi: 10.1161/CIR.0000000000000757. Epub 2020 Jan 29.

  PMID: 31992061 BACKGROUND

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

Lip4 protein, Candida rugosa

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Fergus Shanahan, MD, PhD

  Cork University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2022
• First Posted: March 24, 2022
• Study Start: March 13, 2014
• Primary Completion: October 6, 2014
• Study Completion: November 4, 2014
• Last Updated: March 24, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)