Status:
COMPLETED
Effect of Candida Rugosa Lipase on Serum Triglyceride Lowering
Lead Sponsor:
BIO-CAT, Inc.
Collaborating Sponsors:
Atlantia Food Clinical Trials
Cork University Hospital
Conditions:
Hypertriglyceridemia
Eligibility:
All Genders
18-75 years
Phase:
NA
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...
Detailed Description
According to the World Health Organization, ischemic heart diseases and stroke were the leading causes of death globally in 2019, accounting for 16% and 11% of the world's total deaths, respectively. ...
Eligibility Criteria
Inclusion
- 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)
Exclusion
- 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
Key Trial Info
Start Date :
March 13 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 4 2014
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT05295134
Start Date
March 13 2014
End Date
November 4 2014
Last Update
March 24 2022
Active Locations (1)
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1
Atlantia Food Clinical Trials, Western Gateway Bldg, University College Cork
Cork, Co. Cork, Ireland, T12 XF62