Ubiquinol + Ubiquinone for Borderline High Cholesterol
What You Need to Know Before You Apply
What is the purpose of this trial?
This randomized, double-blind, placebo-controlled clinical trial will evaluate the effects of Ubiquinol and Ubiquinone on vascular endothelial function in generally healthy adults with borderline high LDL-cholesterol. Participants will receive Ubiquinol 200 mg/day, Ubiquinone 200 mg/day, or placebo for 8 weeks. The primary outcome is change in flow-mediated dilation (FMD), a measure of vascular endothelial function, assessed at baseline, Week 4, and Week 8. The study will also evaluate changes in plasma CoQ10 levels, nitric oxide, LDL oxidation susceptibility, oxidative stress markers, and treatment-emergent adverse events.
Are You a Good Fit for This Trial?
This trial is for generally healthy adults who have borderline high LDL cholesterol. People with major health problems or on certain medications may not be eligible.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive Ubiquinol 200 mg/day, Ubiquinone 200 mg/day, or placebo for 8 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Trial Overview
The study tests whether taking Ubiquinol or Ubiquinone (both forms of CoQ10) daily for 8 weeks improves blood vessel function compared to a placebo. Participants are randomly assigned and neither they nor the researchers know which treatment they're getting.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Placebo Group
Participants will receive Ubiquinone 200 mg/day, administered orally as two soft capsules once daily for 8 weeks. Participants will be instructed to take the capsules with water or warm water after breakfast or lunch containing fat.
Participants will receive Ubiquinol 200 mg/day, administered orally as two soft capsules once daily for 8 weeks. Participants will be instructed to take the capsules with water or warm water after breakfast or lunch containing fat.
Participants will receive identical placebo soft capsules orally as two capsules once daily for 8 weeks, according to the study randomization schedule.
Find a Clinic Near You
Who Is Running the Clinical Trial?
SF Research Institute, Inc.
Lead Sponsor
Kaneka Corporation
Industry Sponsor
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