Borderline High LDL-cholesterolNCT07881601
Effects of Ubiquinol and Ubiquinone on Vascular Function in Healthy Adults With Borderline High LDL-Cholesterol
A study testing Ubiquinol and Ubiquinone in people with Borderline High LDL-cholesterol, run by SF Research Institute, Inc. at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Borderline High LDL-cholesterol
- What is being tested?
- Ubiquinol and Ubiquinone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2026to 22 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males aged 35-65 with BMI 18.5-29.9 kg/m².
- Post-menopausal females up to age 65 with BMI 18.5-29.9 kg/m².
- Generally healthy individuals with mild cardiovascular risk factors, specifically -borderline high LDL-C between 100 and 159 mg/dL.
- No current acute or uncontrolled chronic illness.
- Screening FMD: 2.5-6.0%.
Who cannot join
- Having been diagnosed with known allergies to any ingredients in the product.
- Relevant history or presence of any medical disorder potentially interfering with this study, including but not limited to malabsorption, significant gastrointestinal diseases (e.g., severe constipation, diarrhea, inflammatory bowel disease such as Crohn's disease or ulcerative colitis), severe psychiatric illness which in the opinion of the investigator would interfere with optimal participation in the study, and known cardiovascular disease or stroke, except for conditions deemed clinically insignificant by the investigator (e.g., clinically insignificant atherosclerotic lesions observed by imaging studies).
- Smokers >10 cigarettes per day.
- Subjects consuming >2 alcoholic units per day.
- Subjects reporting a change >5% in body weight within 1 month prior to Screening Visit.
- Subjects playing competitive or high-intensity physical activity.
Show all 16Show fewer
- Subjects using lipid-altering drug therapy or supplements, nitric oxide donors, phosphodiesterase inhibitors, high-dose antioxidant supplements (including vitamin C), flavonoid-enriched products, or Ubiquinol/Ubiquinone supplements within 4 weeks prior to Screening Visit.
- Having a history of cancer within the past 5 years.
- Having a history of immunosuppression/immune deficiency disorders, including HIV infection, AIDS, multiple sclerosis, Crohn's disease, rheumatoid arthritis, organ transplant, or currently using oral or systemic immunosuppressive medications and biologics and/or undergoing radiation or chemotherapy.
- Currently using or having regularly used corticosteroids (systemic or topical, not nasal or ocular) within the past 4 weeks.
- Having diseases such as asthma, diabetes, epilepsy, hypertension, hyperthyroidism, or hypothyroidism that are not controlled by diet or medication.
- Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Having started a long-term medication within the last 2 months.
- Having planned surgeries or invasive medical procedures during the study.
- Noninvasive medical procedures or surgeries will be reviewed for their impact on the study outcome and acceptability by the Investigator or designee.
- Currently participating in any other clinical trial at SFRI or another research facility or doctor's office.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
San Francisco Research Institute
San Francisco, California, 94132
About this study
Official title: Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Reduced and Oxidized CoQ10 on Vascular Function in Healthy Adults With Borderline High LDL-Cholesterol
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.
Read the detailed description
This randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate and compare the effects of reduced CoQ10 (Ubiquinol) and oxidized CoQ10 (Ubiquinone) on vascular endothelial function in generally healthy adults with borderline high LDL-cholesterol.
Coenzyme Q10 (CoQ10) exists in two interconvertible forms, reduced CoQ10 (Ubiquinol) and oxidized CoQ10 (Ubiquinone). The study is designed to determine whether Ubiquinol provides a superior effect on vascular endothelial function compared with Ubiquinone and placebo. Vascular endothelial function will be assessed using brachial artery flow-mediated dilation (FMD), a non-invasive measure of endothelial function.
A total of 120 eligible participants will be enrolled and randomized in a 1:1:1 ratio to one of three treatment groups: Ubiquinol 200 mg/day, Ubiquinone 200 mg/day, or identical placebo. Participants will take two soft capsules once daily for 8 weeks, preferably after breakfast or lunch containing fat, with water or warm water.
The study population will consist of generally healthy males aged 35-65 years and post-menopausal females up to 65 years of age, with a BMI of 18.5-29.9 kg/m² and borderline high LDL-cholesterol between 100 and 159 mg/dL. Eligible participants will also have a screening FMD value between 2.5% and 6.0% and no current acute or uncontrolled chronic illness.
Study assessments will be performed at baseline, Week 4, and Week 8. The primary endpoint is the change in FMD from baseline through Week 4 and Week 8. Secondary assessments will include changes in plasma CoQ10 levels, including total, reduced (Ubiquinol), and oxidized (Ubiquinone) CoQ10 concentrations and the reduced-to-total CoQ10 ratio. Additional secondary assessments will include plasma nitric oxide measured through nitrite/nitrate quantification, LDL oxidation susceptibility, and oxidative stress markers including malondialdehyde (MDA), oxidized LDL (oxLDL), and total antioxidant capacity (TAC).
Safety will be evaluated throughout the 8-week study by assessing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
The primary objective is to evaluate the superiority of reduced CoQ10 (Ubiquinol) over oxidized CoQ10 (Ubiquinone) in improving vascular endothelial function as measured by FMD. The study will also generate scientific evidence regarding the effects of the two forms of CoQ10 and collect mechanistic and biomarker data that may support future structure/function claims and related scientific and commercial applications.
- Conditions
- Borderline High LDL-cholesterol
- Being tested
- Ubiquinol, Ubiquinone, Placebo
- Keywords
- Ubiquinol, Ubiquinone, Coenzyme Q10 CoQ10, Vascular endothelial function, Flow-mediated dilation FMD, LDL-cholesterol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UbiquinolDietary supplement
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.
UbiquinoneDietary supplement
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.
PlaceboOther
Identical placebo soft capsules administered orally as two capsules once daily for 8 weeks according to the study randomization schedule.
| Study group | Role | What they receive |
|---|---|---|
| Ubiquinol 200 mg/day | Experimental | 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. Receives: Dietary Supplement: Ubiquinol |
| Ubiquinone 200 mg/day | Experimental | 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. Receives: Dietary Supplement: Ubiquinone |
| Placebo | Placebo comparator | Participants will receive identical placebo soft capsules orally as two capsules once daily for 8 weeks, according to the study randomization schedule. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Flow-Mediated Dilation (FMD)
Change in Flow-Mediated Dilation (FMD), a measure of vascular endothelial function.
Measured: Baseline, Week 4, Week 8
Secondary outcomes (9)
Change in Total Plasma CoQ10 Concentration
Change from baseline in the absolute concentration of total coenzyme Q10 (CoQ10) in plasma, measured in μg/mL.
Measured: Baseline, Week 4, Week 8
Change in Plasma Ubiquinol Concentration
Change from baseline in the absolute concentration of reduced coenzyme Q10 (ubiquinol) in plasma, measured in μg/mL.
Measured: Baseline, Week 4, Week 8
Change in Plasma Ubiquinone Concentration
Change from baseline in the absolute concentration of oxidized coenzyme Q10 (ubiquinone) in plasma, measured in μg/mL.
Measured: Baseline, Week 4, Week 8
Change in Ratio of Reduced to Total CoQ10
Change from baseline in the ratio of reduced CoQ10 (ubiquinol) to total CoQ10 in plasma.
Measured: Baseline, Week 4, Week 8
Change in Plasma Nitric Oxide (NO)
Change from baseline in plasma nitric oxide (NO), assessed by nitrite/nitrate quantification.
Measured: Baseline, Week 4, Week 8
Change in LDL Oxidation Susceptibility
Change from baseline in LDL oxidation susceptibility, measured as lag time using a copper-induced assay.
Measured: Baseline, Week 4, Week 8
Change in Malondialdehyde (MDA) Levels
Change from baseline in serum levels of malondialdehyde (MDA), an oxidative stress marker.
Measured: Baseline, Week 4, Week 8
Change in Oxidized LDL (oxLDL) Levels
Change from baseline in serum levels of oxidized low-density lipoprotein (oxLDL), an oxidative stress marker.
Measured: Baseline, Week 4, Week 8
Change in Total Antioxidant Capacity (TAC)
Change from baseline in serum total antioxidant capacity (TAC).
Measured: Baseline, Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start4 Nov 2026 (estimated)
- Primary completion8 Jan 2027 (estimated)
- Study completion22 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Borderline High LDL-cholesterolStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SF Research Institute, Inc.
- Sponsor type
- Research network
- Collaborators
- Kaneka Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07881601
- Sponsor's protocol ID
- SF/2026/1360/CoQ10/01
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Effects of Reduced and Oxidized CoQ10 on Vascular Function in Healthy Adults With Borderline High LDL-Cholesterol
- ClinicalTrials.gov ID
- NCT07881601
- Acronym / sponsor ID
- SF/2026/1360/CoQ10/01
- Conditions
- Borderline High LDL-cholesterol
- Keywords
- Ubiquinol, Ubiquinone, Coenzyme Q10 CoQ10, Vascular endothelial function, Flow-mediated dilation FMD, LDL-cholesterol
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- SF Research Institute, Inc.Research network
- Collaborators
- Kaneka Corporation
- Study start
- 4 Nov 2026 (estimated)
- Primary completion
- 8 Jan 2027 (estimated)
- Study completion
- 22 Jan 2027 (estimated)
- First posted
- 19 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double-blind, placebo-controlled, parallel-group clinical trial is designed to evaluate and compare the effects of reduced CoQ10 (Ubiquinol) and oxidized CoQ10 (Ubiquinone) on vascular endothelial function in generally healthy adults with borderline high LDL-cholesterol.
Coenzyme Q10 (CoQ10) exists in two interconvertible forms, reduced CoQ10 (Ubiquinol) and oxidized CoQ10 (Ubiquinone). The study is designed to determine whether Ubiquinol provides a superior effect on vascular endothelial function compared with Ubiquinone and placebo. Vascular endothelial function will be assessed using brachial artery flow-mediated dilation (FMD), a non-invasive measure of endothelial function.
A total of 120 eligible participants will be enrolled and randomized in a 1:1:1 ratio to one of three treatment groups: Ubiquinol 200 mg/day, Ubiquinone 200 mg/day, or identical placebo. Participants will take two soft capsules once daily for 8 weeks, preferably after breakfast or lunch containing fat, with water or warm water.
The study population will consist of generally healthy males aged 35-65 years and post-menopausal females up to 65 years of age, with a BMI of 18.5-29.9 kg/m² and borderline high LDL-cholesterol between 100 and 159 mg/dL. Eligible participants will also have a screening FMD value between 2.5% and 6.0% and no current acute or uncontrolled chronic illness.
Study assessments will be performed at baseline, Week 4, and Week 8. The primary endpoint is the change in FMD from baseline through Week 4 and Week 8. Secondary assessments will include changes in plasma CoQ10 levels, including total, reduced (Ubiquinol), and oxidized (Ubiquinone) CoQ10 concentrations and the reduced-to-total CoQ10 ratio. Additional secondary assessments will include plasma nitric oxide measured through nitrite/nitrate quantification, LDL oxidation susceptibility, and oxidative stress markers including malondialdehyde (MDA), oxidized LDL (oxLDL), and total antioxidant capacity (TAC).
Safety will be evaluated throughout the 8-week study by assessing treatment-emergent adverse events (TEAEs) and treatment-emergent serious adverse events (TESAEs).
The primary objective is to evaluate the superiority of reduced CoQ10 (Ubiquinol) over oxidized CoQ10 (Ubiquinone) in improving vascular endothelial function as measured by FMD. The study will also generate scientific evidence regarding the effects of the two forms of CoQ10 and collect mechanistic and biomarker data that may support future structure/function claims and related scientific and commercial applications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ubiquinol 200 mg/day | Experimental | Dietary Supplement: UbiquinolParticipants 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. |
| Ubiquinone 200 mg/day | Experimental | Dietary Supplement: UbiquinoneParticipants 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. |
| Placebo | Placebo comparator | Other: PlaceboParticipants will receive identical placebo soft capsules orally as two capsules once daily for 8 weeks, according to the study randomization schedule. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Males aged 35-65 with BMI 18.5-29.9 kg/m².
- Post-menopausal females up to age 65 with BMI 18.5-29.9 kg/m².
- Generally healthy individuals with mild cardiovascular risk factors, specifically -borderline high LDL-C between 100 and 159 mg/dL.
- No current acute or uncontrolled chronic illness.
- Screening FMD: 2.5-6.0%.
Key exclusion criteria (16 listed)
- Having been diagnosed with known allergies to any ingredients in the product.
- Relevant history or presence of any medical disorder potentially interfering with this study, including but not limited to malabsorption, significant gastrointestinal diseases (e.g., severe constipation, diarrhea, inflammatory bowel disease such as Crohn's disease or ulcerative colitis), severe psychiatric illness which in the opinion of the investigator would interfere with optimal participation in the study, and known cardiovascular disease or stroke, except for conditions deemed clinically insignificant by the investigator (e.g., clinically insignificant atherosclerotic lesions observed by imaging studies).
- Smokers >10 cigarettes per day.
- Subjects consuming >2 alcoholic units per day.
- Subjects reporting a change >5% in body weight within 1 month prior to Screening Visit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UbiquinolUbiquinol 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. | Dietary supplement | Ubiquinol 200 mg/day |
| UbiquinoneUbiquinone 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. | Dietary supplement | Ubiquinone 200 mg/day |
| PlaceboIdentical placebo soft capsules administered orally as two capsules once daily for 8 weeks according to the study randomization schedule. | Other | Placebo |
Primary outcome
Change in Flow-Mediated Dilation (FMD)
Time frame: Baseline, Week 4, Week 8
Change in Flow-Mediated Dilation (FMD), a measure of vascular endothelial function.
9 secondary outcomes
Change in Total Plasma CoQ10 Concentration
Time frame: Baseline, Week 4, Week 8
Change in Plasma Ubiquinol Concentration
Time frame: Baseline, Week 4, Week 8
Change in Plasma Ubiquinone Concentration
Time frame: Baseline, Week 4, Week 8
Change in Ratio of Reduced to Total CoQ10
Time frame: Baseline, Week 4, Week 8
Change in Plasma Nitric Oxide (NO)
Time frame: Baseline, Week 4, Week 8
Change in LDL Oxidation Susceptibility
Time frame: Baseline, Week 4, Week 8
Change in Malondialdehyde (MDA) Levels
Time frame: Baseline, Week 4, Week 8
Change in Oxidized LDL (oxLDL) Levels
Time frame: Baseline, Week 4, Week 8
Change in Total Antioxidant Capacity (TAC)
Time frame: Baseline, Week 4, Week 8
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ubiquinol and Ubiquinone in people with Borderline High LDL-cholesterol, run by SF Research Institute, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Flow-Mediated Dilation (FMD) (time frame: Baseline, Week 4, Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.