Status:
COMPLETED
A Study to Evaluate the Effect of GFA-918 on Serum Triglyceride Levels in Individuals With Elevated Serum Triglyceride
Lead Sponsor:
BIO-CAT Microbials, LLC
Collaborating Sponsors:
KGK Science Inc.
Conditions:
Elevated Triglycerides
Eligibility:
All Genders
30-70 years
Phase:
PHASE2
Brief 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 produ...
Eligibility Criteria
Inclusion
- Females and male within the age range of 30 to 70 at screening;
- BMI of 20 - 34.9 kg/m2 at screening;
- Not of child bearing potential, which is defined as females who have had hysterectomy or oophorectomy, bilateral tubal ligation or are post-menopausal (natural or surgically with \> 1 year since last menstruation) OR,
- Female participants of childbearing potential must agree to use a medically approved method of birth control and have a negative urine pregnancy test result, prior to enrollment. All hormonal birth controls require a minimum stability of three months and remain consistent throughout the study. Acceptable methods of birth control include:
- Hormonal contraceptives; oral, hormone patch (Ortho Evra), vaginal ring (NuvaRing), injectable (Depo-Provera, Lunelle), or hormone implant (Norplant System)
- Double-barrier method
- Intrauterine devices
- Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)
- Vasectomy of partner (shown successful as per appropriate follow-up);
- Sedentary life style as defined by Sedentary Behavior Questionnaire (Appendix II) at screening;
- Serum triglycerides 1.91 - 3.93 mmol/L (175 - 350 mg/dL) (inclusive) at screening;
- Willing to maintain current levels of activity throughout the study;
- Stable with no health concerns for participating in the study as determined by laboratory results, and medical history;
- Willingness to complete all study visits and requirements associated with the study;
- Has access to a computer, tablet, or smart phone with internet connection;
- Has given voluntary, written, informed consent to participate in the study.
Exclusion
- Individuals who are pregnant, breastfeeding, or planning to become pregnant;
- LDL-C ≥ 4.1 mmol/L (160 mg/dL);
- Uncontrolled hypertension, defined as untreated systolic blood pressure \> 150 mmHg and/or diastolic blood pressure \> 90 mmHg;
- Cancer(s), except skin cancers completely excised with no chemotherapy or radiation with a negative follow up. and cancer(s) in full remission for more than five years after diagnosis
- Immunocompromised individuals such as those that have undergone organ transplantation, those with rheumatoid arthritis, or those diagnosed with human immunodeficiency virus (HIV) or AIDS by verbal confirmation;
- Verbal confirmation of current, or history of, bleeding disorders and/or medically prescribed anticoagulant/antiplatelet drugs (refer to Section 5.3);
- Verbal confirmation of current unstable thyroid disease state; however, participants who have been on stable medication for \>6 months will be eligible to participate but will be assessed on a case by case basis by the QI.
- Verbal confirmation of GI disorders and on anti-inflammatory drugs to control GI disorders; however, participants who have been on stable medication for \>6 months will be eligible to participate but will be assessed on a case by case basis by the QI
- Verbal confirmation of Type I and Type II Diabetes;
- Anti-inflammatory medication, corticosteroids, lipid lowering agents and diabetic medication (refer to Section 5.3) as assessed by the QI;
- Alcohol or drug abuse within the last 6 months;
- No more than 2 standard alcoholic drinks per day;
- Verbal confirmation of marijuana use \>4 times a week
- Tobacco products, including e-cigarette; dose and frequency will be assessed on a case by case basis by the QI
- Participation in a clinical research study within 30 days of enrollment;
- Allergy or sensitivity to study product ingredients;
- Clinically significant abnormal laboratory results at screening;
- Unstable medical conditions as assessed by the Qualified Investigator;
- Individuals who are cognitively impaired and/or unable to give informed consent;
- Any other condition which in the Qualified Investigator's opinion may adversely affect the participant's ability to complete the study or its measures or which may pose significant risk to the participant.
Key Trial Info
Start Date :
July 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2021
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT04754373
Start Date
July 13 2018
End Date
December 6 2021
Last Update
December 22 2021
Active Locations (2)
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1
KGK Science
London, Ontario, Canada, N6A 5R8
2
Canadian College of Naturopathic Medicine
Toronto, Ontario, Canada, M2K 1E2