Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations

Phase 4

Not yet recruiting

• Conditions: Wellness; Health

• Registration Number: NCT06640465
• Lead Sponsor: OvationLab

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10
• Study First Submitted: 2024-10-10
• Study First Submitted QC: 2024-10-10
• Last Update Submitted: 2024-10-11
• Study First Posted: 2024-10-15
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-03
• Study Completion: 2025-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Adult males or females age ≥ 40 years
2. Ability to read and speak English

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Plasma Coenzyme Q10	Baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
Comprehensive metabolic panel	Baseline and 8 weeks	Alanine aminotransferase (ALT) in units per liter (U/L)
Lipid panel	Baseline and 8 weeks	Low-density lipoprotein (LDL) in milligrams per deciliter (mg/dL)
Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health	Baseline and 8 weeks	Raw scores range from 4 to 20, with higher scores indicating better global physical or mental health compared to the average
Profile of Mood States - Vigor Subscale	Baseline and 8 weeks	Scores range from 0 to 32, with higher scores indicating better energy levels
Short Form 36 (SF-36) - Vitality Subscale	Baseline and 8 weeks	Scores range from 0 to 100, with higher scores indicating greater vitality

Trial Locations

Locations (6)

True Health Center for Precision Medicine; 🇺🇸 El Dorado Hills, California, United States

Cornerstone Health Community; 🇺🇸 Centennial, Colorado, United States

CTMD Research; 🇺🇸 Palm Springs, Florida, United States

Functional Medicine of Idaho; 🇺🇸 Eagle, Idaho, United States

New Dawn Wellness and Medical Center; 🇺🇸 Houston, Texas, United States

Vida Integrated Health; 🇺🇸 Seattle, Washington, United States