- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06640465
Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
A Randomized, Placebo-Controlled Trial Comparing the Effects of Commercially Available Dietary Supplements on CoQ10 Concentrations
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.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
-
-
California
-
El Dorado Hills, California, United States, 95762
- True Health Center for Precision Medicine
-
-
Colorado
-
Centennial, Colorado, United States, 80111
- Cornerstone Health Community
-
-
Florida
-
Palm Springs, Florida, United States, 33046
- CTMD Research
-
-
Idaho
-
Eagle, Idaho, United States, 83616
- Functional Medicine of Idaho
-
-
Texas
-
Houston, Texas, United States, 77082
- New Dawn Wellness and Medical Center
-
-
Washington
-
Seattle, Washington, United States, 98122
- Vida Integrated Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Placebo Comparator: Placebo
|
Placebo capsule
|
|
Experimental: Geranylgeraniol (Annatto-GG™ 300)
|
Geranylgeraniol alone
|
|
Experimental: Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)
|
Ubiquinol alone
|
|
Experimental: Ubiquinone (NOW CoQ10 200mg)
|
Ubiquinone alone
|
|
Experimental: Ubiquinol + geranylgeraniol combination (Designs for Health - CoQnol™ 200)
|
Combination of ubiquinol and geranylgeraniol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Plasma Coenzyme Q10
Time Frame: Baseline and 8 weeks
|
Baseline and 8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comprehensive metabolic panel
Time Frame: Baseline and 8 weeks
|
Alanine aminotransferase (ALT) in units per liter (U/L)
|
Baseline and 8 weeks
|
|
Lipid panel
Time Frame: Baseline and 8 weeks
|
Low-density lipoprotein (LDL) in milligrams per deciliter (mg/dL)
|
Baseline and 8 weeks
|
|
Patient-Reported Outcomes Measurement Information System (PROMIS) - Global Health
Time Frame: 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
|
Baseline and 8 weeks
|
|
Profile of Mood States - Vigor Subscale
Time Frame: Baseline and 8 weeks
|
Scores range from 0 to 32, with higher scores indicating better energy levels
|
Baseline and 8 weeks
|
|
Short Form 36 (SF-36) - Vitality Subscale
Time Frame: Baseline and 8 weeks
|
Scores range from 0 to 100, with higher scores indicating greater vitality
|
Baseline and 8 weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OvationLab
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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