NCT06640465

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2024

Shorter than P25 for phase_2

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 10, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

October 12, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 17, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 17, 2025

Completed
Last Updated

March 4, 2026

Status Verified

March 1, 2026

Enrollment Period

11 months

First QC Date

October 10, 2024

Last Update Submit

March 2, 2026

Conditions

WellnessHealth

Keywords

Coenzyme Q10CoQ10GeranylgeraniolGGUbiquinolUbiquinone

Outcome Measures

Primary Outcomes (1)

  • Plasma Coenzyme Q10

    Baseline and 8 weeks

Secondary Outcomes (5)

  • 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

Study Arms (5)

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

EXPERIMENTAL
Dietary Supplement: Ubiquinol + geranylgeraniol

Geranylgeraniol (Annatto-GG™ 300)

EXPERIMENTAL
Dietary Supplement: Geranylgeraniol

Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)

EXPERIMENTAL
Dietary Supplement: Ubiquinol

Ubiquinone (NOW CoQ10 200mg)

EXPERIMENTAL
Dietary Supplement: Ubiquinone

Placebo

PLACEBO COMPARATOR
Other: Placebo

Interventions

Ubiquinol + geranylgeraniolDIETARY_SUPPLEMENT

Combination of ubiquinol and geranylgeraniol

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

Geranylgeraniol alone

Geranylgeraniol (Annatto-GG™ 300)
UbiquinolDIETARY_SUPPLEMENT

Ubiquinol alone

Ubiquinol (Jarrow Formulas QH-absorb® 200 mg)
UbiquinoneDIETARY_SUPPLEMENT

Ubiquinone alone

Ubiquinone (NOW CoQ10 200mg)
PlaceboOTHER

Placebo capsule

Placebo

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

True Health Center for Precision Medicine

El Dorado Hills, California, 95762, United States

Location

Cornerstone Health Community

Centennial, Colorado, 80111, United States

Location

CTMD Research

Palm Springs, Florida, 33046, United States

Location

Functional Medicine of Idaho

Eagle, Idaho, 83616, United States

Location

New Dawn Wellness and Medical Center

Houston, Texas, 77082, United States

Location

Vida Integrated Health

Seattle, Washington, 98122, United States

Location

MeSH Terms

Interventions

ubiquinolgeranylgeraniolUbiquinone

Intervention Hierarchy (Ancestors)

BenzoquinonesQuinonesOrganic ChemicalsCoenzymesEnzymes and Coenzymes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2024

First Posted

October 15, 2024

Study Start

October 12, 2024

Primary Completion

September 17, 2025

Study Completion

September 17, 2025

Last Updated

March 4, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will share

Deidentified participant data will be made available upon reasonable request.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The IPD and supporting information will be available within 6 months after the completion of the study.

Locations

US(6)