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

NCT ID: NCT07109115

Last Updated: 2025-08-07

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-09-01

Brief 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. This could lead to safer ways to protect females from heart disease without using hormone therapy.

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.

Conditions

Females; Males; Menopause; Sedentary; Healthy Participants

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Active Comparator 1: 200mg vitamin C

Subjects 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.

Group Type: EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type: DIETARY_SUPPLEMENT

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

Active Comparator 1: 500mg vitamin C

Subjects 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.

Group Type: EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type: DIETARY_SUPPLEMENT

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

Active Comparator 1: 1000mg vitamin C

Subjects 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.

Group Type: EXPERIMENTAL

Vitamin C (Ascorbic Acid)

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo Comparator 1: 0mg Vitamin C

Subjects 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.

Group Type: PLACEBO_COMPARATOR

Vitamin C (Ascorbic Acid)

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Vitamin C (Ascorbic Acid)

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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
• 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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Jason Allen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

UVA

Central Contacts

Casey Derella, PhD

Role: CONTACT

bxg7vn@uvahealth.org

434-924-1655

Ben Stephenson, M.Ed

Role: CONTACT

bls4qq@uvahealth.org

434-924-1062

Other Identifiers

302767

Identifier Type: -

Identifier Source: org_study_id