AzTrials
AzTrials

FemalesPM-VitCNCT07109115

The Effects of Vitamin C on Acute-Exercise in Postmenopausal Females

A study testing Vitamin C (Ascorbic Acid) in people with Females and Males, run by University of Virginia at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This study is looking at whether vitamin C can help improve oxidative stress and blood vessel health in females after menopause. We will see if taking different amounts of vitamin C for a few days changes how the body handles stress from exercise. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Females, Males, Menopause
What is being tested?
Vitamin C (Ascorbic Acid)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1 participants
Where
1 siteUnited States
Study dates
1 Sep 2025to 1 Jul 2026
Phase
Interventional
Are there results?
None posted in the registry

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 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Post-menopausal (for females; defined as no menstrual cycle for 1-year)
  • Sedentary (<150min of moderate-intensity exercise per week or not engaged in a regular exercise program)
  • Non-smoking
  • Weight stable (+/-3 kg over the past 3 months)

Who cannot join

  • Overt CVD
  • Any condition or medication contraindicating safe exercise
  • Hormone replacement therapy (last 3-months)
  • Use of vasoactive medications (e.g., calcium channel blockers, statins, ACE inhibitors, ARBs, nitrates, alpha-/beta-blockers, diuretics), diabetes, or unstable medication regimens
  • Diabetes
  • Oral antibiotic use within previous four weeks
Show all 9Show fewer
  • Oral disease or poor oral health as determined by the Oral Health Questionnaire
  • Using an antibacterial mouthwash or a mouthwash containing chlorhexidine and unwilling to discontinue use
  • Cancer diagnosis

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Student Health and Wellness Building - Department of Kinesiology

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: The Effects of Vitamin C on Exercise-Induced Oxidative Stress in Postmenopausal Females

This study is looking at whether vitamin C can help improve oxidative stress and blood vessel health in females after menopause. We will see if taking different amounts of vitamin C for a few days changes how the body handles stress from exercise. This could lead to safer ways to protect females from heart disease without using hormone therapy.

Read the detailed description

Cardiovascular disease (CVD) remains the leading cause of death in the United States. After menopause, females face a significantly increased risk of CVD due to declines in estrogen, which negatively impact nitric oxide (NO) production and vascular health. This coincides with an increase in reactive oxygen species (ROS), leading to an imbalance in redox signaling that may blunt beneficial adaptations to exercise.

Vitamin C (ascorbic acid) is a potent antioxidant that may restore redox balance and endothelial function. However, most studies have been conducted in males using high doses that may suppress beneficial ROS signaling. In contrast, this trial focuses on the dose-response effects of short-term vitamin C supplementation (200 mg, 500 mg, and 1000 mg/day for 3 days) on ROS/NO balance, both at rest and in response to acute exercise, in PMF versus age-matched males.

The study includes 15 sedentary PMF and 15 sedentary age-matched males, ages 45 and older. Participants complete 5-6 total study visits: one baseline/screening visit and four intervention visits in a randomized crossover design. Each intervention visit consists of 3 days of supplementation followed by fasting blood draws, vascular testing, and a 200-kcal high-intensity exercise bout on a cycle ergometer.

Being tested
Vitamin C (Ascorbic Acid)
Keywords
Vitamin C, Postmenopausal Females, Exercise, Oxidative Stress, Vascular Health
Medical subject headings
Sedentary Behavior, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vitamin C (Ascorbic Acid)Dietary supplement

    Subjects will be supplemented with the following vitamin C doses: 0mg, 200mg, 500mg, 1000mg.

Study groups in NCT07109115
Study groupRoleWhat they receive
Active Comparator 1: 200mg vitamin CExperimentalSubjects will supplement with 200mg of vitamin C 2x a day for 3 days. 100mg will be taken in the morning and 100mg in the evening. On the 3rd day, subjects will be scheduled to return for post-supplementation testing and be instructed to take a full 200mg dose 30-minutes prior to arriving.
Receives: Dietary Supplement: Vitamin C (Ascorbic Acid)
Active Comparator 1: 500mg vitamin CExperimentalSubjects will supplement with 500mg of vitamin C 2x a day for 3 days. Subjects will take half the dose in the morning and half the dose in the evening. On the 3rd day, subjects will be scheduled to return for post-supplementation testing and be instructed to take a full dose 30-minutes prior to arriving.
Receives: Dietary Supplement: Vitamin C (Ascorbic Acid)
Active Comparator 1: 1000mg vitamin CExperimentalSubjects will supplement with 1000mg of vitamin C 2x a day for 3 days. Subjects will take half the dose in the morning and half the dose in the evening. On the 3rd day, subjects will be scheduled to return for post-supplementation testing and be instructed to take a full dose 30-minutes prior to arriving.
Receives: Dietary Supplement: Vitamin C (Ascorbic Acid)
Placebo Comparator 1: 0mg Vitamin CPlacebo comparatorSubjects will supplement with 0mg of vitamin C 2x a day for 3 days. Subjects will take half the dose in the morning and half the dose in the evening. On the 3rd day, subjects will be scheduled to return for post-supplementation testing and be instructed to take a full dose 30-minutes prior to arriving.
Receives: Dietary Supplement: Vitamin C (Ascorbic Acid)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Flow-Mediated Dilation (FMD%) - Brachial Artery Endothelial Function

    Brachial artery endothelial function will be measured by flow-mediated dilation (FMD) in each participant 5x (at baseline and after 0mg (placebo) 200mg, 500mg, and 1000mg of vitamin C). Participants will be placed in a supine position with their left forearm slightly extended and supinated with legs straight. The brachial artery will be imaged using a high-resolution 7.5MHz linear array transducer at rest, during 5 minutes of forearm occlusion via cuff inflation (250mmHg), and continuously for 2 minutes post-occlusion; an EKG trigger will be used to capture images during end-diastole of the cardiac cycle.

    Measured: 5x: Baseline/un-supplemented; after 3-days of 200mg of vitamin C supplementation; after 3-days of 500mg of vitamin C supplementation; after 3-days of 1000mg of vitamin C supplementation; after 3-days of 0mg of vitamin C/placebo supplementation

  2. Basal ROS Concentrations - plasma 8-Isoprostane (8-iso) and malondialdehyde (MDA)

    A venous blood sample will be collected from a vein in the antecubital fossa. Plasma will be separated out and stored at -80C until concentrations of 8-Isoprostane (8-iso) and malondialdehyde (MDA) are measured via commerically available ELISA kits. ROS concentrations will be measured at 5x points: at baseline and after 0mg (placebo), 200mg, 500mg, and 1000mg of vitamin C

    Measured: baseline and after 0mg/placebo, 200mg, 500mg, and 1000mg dose of vitamin C for 3-days each

  3. Resting ROS/NO Balance - plasma N-oxides (nitrite and nitrate)

    Venous blood samples will be collected from an antecubital fossa vein. Plasma will be separated out and stored at -80C until analysis. Plasma N-oxides (nitrite and nitrate) will be evaluated from the plasma via ozone-based chemiluminescence using a Sievers NOA model 280i. The N-oxides will be compared with the basal ROS also measured to calculate a ROS/NO balance.

    Measured: Baseline and after 3-days of placebo, 200mg, 500mg, and 1000mg doses of vitamin C

  4. Exercise-Induced ROS (plasma 8-Isoprostane (8-iso) and malondialdehyde (MDA)) and NO (plasma nitrate and nitrite)

    An intravenous catheter will be placed into a vein in the antecubital fossa. Participants will complete 4 high-intensity exercise sessions (~200kcals). Each exercise session will be after 3-days of vitamin C supplementation (0mg/placebo, 200mg, 500mg, and 1000mg). Blood will be collected immediately before, immediately after, 15-min after, and 30-min after exercise. Plasma will be separated out and used to evaluate the changes in ROS (plasma 8-Isoprostane (8-iso) and malondialdehyde (MDA)) and NO (plasma nitrate and nitrite) from baseline/rest.

    Measured: 16x points: 4 exercise session with blood will be collected immediately before, immediately after, 15-min after, and 30-min after exercise

Secondary outcomes (7)
  1. Vitamin C

    Blood samples will be collected to evaluate compliance. We will measure vitamin C concentrations after each supplementation phase.

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

  2. Oral Nitrate Reducing Capacity

    Assessment of the oral microbiome's ability to reduce nitrate to nitrite. This will be measured through an unstimulated saliva sample and a rinse of a standard nitrate solution.

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

  3. Pulse Wave Analysis and Velocity

    Brachial artery blood pressures will be obtained using a standard sphygmomanometer. Aortic blood pressures will be obtained using applanation tonometry (SphygmoCor version 8.0, AtCor Medical).

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

  4. Microvascular Function

    Participants will remain in a supine position with their left or right forearm slight extended and supinated. The cuff used for FMD will remain in place and two circular discs will be placed on the participants extended forearm. A laser Doppler imager (Moor Instruments - FLPI2) will be positioned directly over the participants forearm to measure skin blood flow in three different ways: microvascular flow mediated dilation, acetylcholine, and local thermal heating.

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

  5. Exercise Capacity

    Participants will exercise using an incremental cycle ergometer protocol with increasing power output until volitional exhaustion is reached. The power output will increase in 3-minute stages, where blood is collected before the start of exercise and at the end of each stage. The LT will be established by analyzing the blood lactate-power output relationship. VO2 peak will be defined as the highest one min value attained during the test.

    Measured: Baseline only

  6. Tissue Perfusion (NIRS)

    Tissue oxygenation will be captured noninvasively using non-invasive, near-infrared spectrometry (NIRS, PortaMon, Artinis Medical Systems B.V., The Netherlands) positioned on the gastrocnemius (calf) or vastus lateralis (quad) muscle during the VO2/LT test and during each Experimental Visit (HIE sessions).

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

  7. Central Hemodynamics (Physioflow)

    : Measures of central hemodynamics (cardiac output, etc.) will be non-invasively captured throughout the VO2/LT test and during each Experimental Visit (HIE sessions). Using electrodes placed on the participant's body and the principles of signal morphology impedance cardiography PhysioFlow provides estimates of central cardiac measures at rest and during exercise non-invasively.

    Measured: 5x points over 5-6 weeks: (1) baseline/unsupplemented and after 3-days of (2) 0mg/placebo, (3) 200mg, (4) 500mg, and (5) 1000mg of vitamin C supplementation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start1 Sep 2025
  3. Primary completion1 Jul 2026
  4. Study completion1 Jul 2026

Why it stopped: Insufficient funds and study personal to complete the trial when the primary grant holder and coordinator resigned from UVA.

Resources

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
Other
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109115
Sponsor's protocol ID
302767
Acronym
PM-VitC
Status last verified
Jul 2026
First submitted
23 Jul 2025
Last updated
17 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Vitamin C (Ascorbic Acid) in people with Females and Males, run by University of Virginia 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 4 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Jul 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?

The study was stopped early (reason given: Insufficient funds and study personal to complete the trial when the primary grant holder and coordinator resigned from UVA.). Results are not available in the source record.

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?

Flow-Mediated Dilation (FMD%) - Brachial Artery Endothelial Function (time frame: 5x: Baseline/un-supplemented; after 3-days of 200mg of vitamin C supplementation; after 3-days of 500mg of vitamin C supplementation; after 3-days of 1000mg of vitamin C supplementation; after 3-days of 0mg of vitamin C/placebo supplementation). The study lists 4 primary outcomes in all. 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 17 Jul 2026.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in