Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

NCT ID: NCT06480695

Last Updated: 2025-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-01

Study Completion Date

2026-12-31

Brief Summary

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Menopause greatly increases cardiovascular disease risk (CVD). Current exercise guidelines are inadequate to ameliorate this risk and higher intensity exercise may be necessary for cardiovascular benefits in postmenopausal females. Oral nitrate supplementation enhances exercise performance and CVD risk profile in several clinical conditions. The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an intensity dependent manner. The effects of nitrate supplementation and exercise training over a longer training program remains unexplored. This investigation will examine the impact of exercise training intensity with and without inorganic nitrate supplementation, on CVD and fitness outcomes. Postmenopausal females will be tested for maximal oxygen uptake and lactate threshold before randomization to one of four groups: that inorganic nitrate-rich beetroot juice, or beetroot juice with nitrate extracted; and assigned to one-month of calorie matched high-intensity or moderate-intensity exercise training. Vascular function and fitness will be evaluated before and after training.

Detailed Description

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Conditions

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Menopause

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized to one-month of either high or moderate aerobic exercise training and then further randomized to nitrate or placebo.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
A study team member not associated with the trial will perform the randomization scheme for the supplementation. Exercise groups will not be blinded but data will not be analyzed until the end or re-labeled by another team member so assessors are unaware while analyzing the data.

Study Groups

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Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.

Group Type EXPERIMENTAL

Nitrate-Rich Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day

High Intensity Exercise

Intervention Type BEHAVIORAL

exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17

Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 15-17 based on the participant's VO2peak test.

Group Type PLACEBO_COMPARATOR

High Intensity Exercise

Intervention Type BEHAVIORAL

exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17

Nitrate-Depleted Placebo Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.

Group Type ACTIVE_COMPARATOR

Nitrate-Rich Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day

Moderate Intensity Exercise

Intervention Type BEHAVIORAL

exercise at the RPE at LT associated an \~ RPE of 10-12

Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE)

Participants assigned to this group will be instructed to consume 1 bottle of nitrate-depleted beetroot juice 2x a day (morning a night) starting 2-hours before the first exercise session. Participants will complete a supervised bout of exercise on a treadmill 3x a week for 1-month. Participants will exercise at an RPE of 10-12 based on the participant's VO2peak test.

Group Type PLACEBO_COMPARATOR

Moderate Intensity Exercise

Intervention Type BEHAVIORAL

exercise at the RPE at LT associated an \~ RPE of 10-12

Nitrate-Depleted Placebo Beetroot Juice

Intervention Type DIETARY_SUPPLEMENT

Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Interventions

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Nitrate-Rich Beetroot Juice

subjects will consume 1 bottle of nitrate-rich beetroot juice (\~400mg of nitrate each) 2x a day

Intervention Type DIETARY_SUPPLEMENT

High Intensity Exercise

exercise at an intensity midway between the lactate threshold and VO2peak, from the screening test at an RPE of \~ 15-17

Intervention Type BEHAVIORAL

Moderate Intensity Exercise

exercise at the RPE at LT associated an \~ RPE of 10-12

Intervention Type BEHAVIORAL

Nitrate-Depleted Placebo Beetroot Juice

Subjects will consume 1 bottle of nitrate-depleted beetroot juice 2x a day

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Inorganic Nitrate James White Beet It

Eligibility Criteria

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Inclusion Criteria

* Post-menopausal female (greater than age 45 but less than age 75)
* Sedentary (does not exercise regularly or less than 2 bouts of exercise per week)
* No major changes in medication in the last 3 months

Exclusion Criteria

* Smokers within last 5 years
* Weight unstable (loss/gain of more than 3kg in the past 3 months)
* Any medical condition that prevents the subject from exercising safely
* Hormone replacement therapy (current or within last 3 months)
* Diabetes
* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
* 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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Virginia

OTHER

Sponsor Role lead

Responsible Party

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Jason Allen

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jason Allen, PhD

Role: PRINCIPAL_INVESTIGATOR

UVA

Locations

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Student Health and Wellness Building - Department of Kinesiology

Charlottesville, Virginia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Casey Derella, PhD

Role: CONTACT

434-924-1655

Facility Contacts

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Casey Derella, PhD

Role: primary

434-924-1655

Other Identifiers

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HSR231665

Identifier Type: -

Identifier Source: org_study_id

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