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

NCT ID: NCT04754373

Last Updated: 2021-12-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-13
• Study Completion Date: 2021-12-06

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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

GFA-918

Participants will be instructed to take one GFA-918 capsule twice per day with their morning and evening meals for 12 weeks.

Group Type: EXPERIMENTAL

GFA-918

Intervention Type: DIETARY_SUPPLEMENT

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.

Placebo

Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Participants will be instructed to take one Placebo capsule twice per day with their morning and evening meals for 12 weeks.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

1. Females and male within the age range of 30 to 70 at screening;

2. BMI of 20 - 34.9 kg/m2 at screening;

3. 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);

4. Sedentary life style as defined by Sedentary Behavior Questionnaire (Appendix II) at screening;

5. Serum triglycerides 1.91 - 3.93 mmol/L (175 - 350 mg/dL) (inclusive) at screening;

6. Willing to maintain current levels of activity throughout the study;

7. Stable with no health concerns for participating in the study as determined by laboratory results, and medical history;

8. Willingness to complete all study visits and requirements associated with the study;

9. Has access to a computer, tablet, or smart phone with internet connection;

10. Has given voluntary, written, informed consent to participate in the study.

Exclusion Criteria

1. Individuals who are pregnant, breastfeeding, or planning to become pregnant;

2. LDL-C ≥ 4.1 mmol/L (160 mg/dL);

3. Uncontrolled hypertension, defined as untreated systolic blood pressure > 150 mmHg and/or diastolic blood pressure > 90 mmHg;

4. 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

5. 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;

6. Verbal confirmation of current, or history of, bleeding disorders and/or medically prescribed anticoagulant/antiplatelet drugs (refer to Section 5.3);

7. 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.

8. 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

9. Verbal confirmation of Type I and Type II Diabetes;

10. Anti-inflammatory medication, corticosteroids, lipid lowering agents and diabetic medication (refer to Section 5.3) as assessed by the QI;

11. Alcohol or drug abuse within the last 6 months;

12. No more than 2 standard alcoholic drinks per day;

13. Verbal confirmation of marijuana use >4 times a week

14. Tobacco products, including e-cigarette; dose and frequency will be assessed on a case by case basis by the QI

15. Participation in a clinical research study within 30 days of enrollment;

16. Allergy or sensitivity to study product ingredients;

17. Clinically significant abnormal laboratory results at screening;

18. Unstable medical conditions as assessed by the Qualified Investigator;

19. Individuals who are cognitively impaired and/or unable to give informed consent;

20. 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.

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

KGK Science Inc.

INDUSTRY

Sponsor Role: collaborator

BIO-CAT Microbials, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Crowley, MD

Role: PRINCIPAL_INVESTIGATOR

KGK Science

Locations

KGK Science

London, Ontario, Canada

Canadian College of Naturopathic Medicine

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

17GTHB

Identifier Type: -

Identifier Source: org_study_id