A Randomized, Placebo-Controlled Trial Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations

OvationLab12 sites in 1 country150 target enrollmentOctober 12, 2024

ConditionsWellness Health

InterventionsUbiquinone Placebo Geranylgeraniol Ubiquinol + geranylgeraniol Ubiquinol

Overview

Phase: Phase 2
Intervention: Ubiquinone
Conditions: Wellness
Sponsor: OvationLab
Enrollment: 150
Locations: 12
Primary Endpoint: Plasma Coenzyme Q10
Status: Completed
Last Updated: last month

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The primary purpose of this study is to compare the safety and effectiveness of commercially available dietary supplements believed to increase coenzyme Q10 (CoQ10) concentrations.

An 8-week, randomized, placebo-controlled clinical trial will be conducted comparing the effectiveness of four commercially available dietary supplements on increasing CoQ10 concentrations and self-reported health outcomes.

Registry

clinicaltrials.gov

Start Date

October 12, 2024

End Date

September 17, 2025

Last Updated

last month

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

OvationLab

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Adult males or females age ≥ 40 years
•Ability to read and speak English

Exclusion Criteria

•Daily use within the past 2 months of any dietary supplements containing CoQ10 or geranylgeraniol (GG)
•Taking a statin medication within the past 6 months
•Current daily usage of H2 blockers or PPI medications
•Current daily use of bisphosphonates
•Current daily tobacco smoker
•Known allergies to any substance in the study products
•Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
•Current diagnosis of a chronic health condition (e.g., cancer, Crohn's disease) deemed clinically contraindicated for the study protocol.
•Participant in a clinical trial in the previous 30 days.
•Participants unable to provide consent

Arms & Interventions

Ubiquinone (NOW CoQ10 200mg)

Intervention: Ubiquinone

Placebo

Intervention: Placebo

Geranylgeraniol (Annatto-GG™ 300)

Intervention: Geranylgeraniol

Ubiquinol + geranylgeraniol combination (Designs for Health - CoQnol™ 200)

Intervention: Ubiquinol + geranylgeraniol

Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)

Intervention: Ubiquinol

Outcomes

Primary Outcomes

Plasma Coenzyme Q10

Time Frame: Baseline and 8 weeks

Secondary Outcomes

Comprehensive metabolic panel(Baseline and 8 weeks)
Lipid panel(Baseline and 8 weeks)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health(Baseline and 8 weeks)
Profile of Mood States - Vigor Subscale(Baseline and 8 weeks)
Short Form 36 (SF-36) - Vitality Subscale(Baseline and 8 weeks)