Nitrate Supplementation and Exercise for Menopause

Overseen By Casey Derella, PhD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Virginia

Must not be taking: Vasoactive medications, Hormone therapy

Disqualifiers: Smoking, Diabetes, Oral disease, others

Compensation: Varies

Number of Visits: 13

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether beetroot juice can improve heart health and fitness in postmenopausal women, particularly when combined with varying exercise levels. Researchers aim to determine if drinking either nitrate-rich or nitrate-depleted beetroot juice, alongside high or moderate-intensity exercise, can lower the risk of cardiovascular disease, which often increases after menopause. The trial seeks postmenopausal women who do not exercise regularly and have not recently changed their medication. Participation involves a month-long exercise program with supervised treadmill sessions three times a week. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research on heart health and fitness.

Will I have to stop taking my current medications?

The trial requires that you are not currently or recently on certain medications like calcium channel blockers, statins, and others. If you are taking these, you would need to stop before participating.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that beetroot juice, high in nitrates, is generally safe for people. One study found that drinking this juice for a week improved blood vessel function in postmenopausal women. Other research suggests that beetroot juice can boost heart health and aid recovery after exercise.

Another study demonstrated that nitrate-rich beetroot juice helped protect blood vessels from damage in healthy, postmenopausal women. However, a different study found that while increased nitrates altered how the body processed them, they did not affect blood vessel function or blood pressure over four weeks.

Overall, evidence suggests that beetroot juice with nitrates is well-tolerated. Side effects are not commonly reported, making it a promising option for those considering this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about using nitrate-rich beetroot juice combined with exercise for menopause because it introduces a natural approach to managing symptoms, unlike traditional hormone replacement therapies. Nitrate-rich beetroot juice is notable for its high nitrate content, which can enhance blood flow and improve exercise efficiency, providing a potential boost in energy and cardiovascular health. This method also pairs with tailored exercise regimens, which could offer a holistic and non-invasive alternative for women seeking relief from menopause symptoms.

What evidence suggests that this trial's treatments could be effective for menopause-related cardiovascular risk?

Research has shown that beetroot juice, rich in nitrates, can enhance exercise performance and heart health in postmenopausal women. Studies have found that just three days of nitrate intake can improve blood vessel function after exercise. In this trial, researchers will assign participants to different groups to test the effects of nitrate-rich beetroot juice combined with either high or moderate intensity exercise. Consuming beetroot juice before workouts can increase fitness benefits. Another study found that beetroot juice can also boost muscle strength and heart function. Therefore, combining beetroot juice with exercise, especially more intense workouts, might offer additional heart health benefits for postmenopausal women. ^{1 6 7 8 9}

Who Is on the Research Team?

Jason Allen, PhD

Principal Investigator

UVA

Are You a Good Fit for This Trial?

This trial is for post-menopausal women aged 45-75 who are sedentary, meaning they exercise less than twice a week. They should not have had any major medication changes in the past three months.

Inclusion Criteria

I do not exercise regularly or less than twice a week.

My medications have been stable for the last 3 months.

I am a woman aged between 45 and 75 and have gone through menopause.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants are tested for maximal oxygen uptake and lactate threshold before randomization

1 week

1 visit (in-person)

Treatment

Participants undergo 1-month of exercise training with either nitrate-rich or nitrate-depleted beetroot juice

4 weeks

12 visits (in-person, 3x a week)

Follow-up

Participants are monitored for vascular function and fitness outcomes after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• High Intensity Exercise
• Moderate Intensity Exercise
• Nitrate-Depleted Placebo Beetroot Juice
• Nitrate-Rich Beetroot Juice

Trial Overview The study tests if beetroot juice with nitrates or without (placebo) combined with either high-intensity or moderate-intensity exercise affects cardiovascular health and fitness in postmenopausal females over one month.

How Is the Trial Designed?

Group I: Nitrate-Rich Beetroot Juice + High Intensity Exercise (HIE) Experimental Treatment 2 Interventions

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 II: Nitrate-Rich Beetroot Juice + Moderate Intensity Exercise (MIE) Active Control 2 Interventions

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 III: Nitrate-Depleted Placebo Beetroot Juice + Moderate Intensity Exercise (MIE) Placebo Group 2 Interventions

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 IV: Nitrate-Depleted Placebo Beetroot Juice + High Intensity Exercise (HIE) Placebo Group 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials

802

Recruited

1,342,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12524760/

Beetroot Supplementation as a Nutritional Strategy to Support ... Evidence from exercise trials suggests both benefits and limitations of beetroot juice (BJ) supplementation: BJ has been shown to improve blood ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06480695

Exercise Training Intensity and Nitrate Supplementation in ... The investigators recently reported that 3-days of nitrate supplementation in postmenopausal females enhances acute post-exercise vascular function, in an ...

3. physiology.org physiology.org/detail/news/2024/11/18/pre-workout-beetroot-juice-improves-fitness-gains-in-late-postmenopausal-women

Pre-Workout Beetroot Juice Improves Fitness Gains in Late ... Drinking beetroot juice before a workout could enhance the benefits of exercise training in postmenopausal women, according to new research.

4. examine.com examine.com/research-feed/study/1YYMo1/?srsltid=AfmBOoqE3UUP6WbeAqoftX2gWgTxBpSKO11A5LVAkbu51RHVM1Ncb4d_

The effect of nitrate supplementation on muscle strength ... In this 8-week randomized controlled trial in 22 postmenopausal women (average age of 66), daily supplementation with nitrate from beetroot ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0891584923011401

Acute and short-term beetroot juice nitrate-rich ingestion ... Acute and short-term BRJ-NO 3 − rich ingestion may enhance cardiovascular and autonomic behavior in response to aerobic exercise in postmenopausal women ...

6. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1359671/full

Seven-day dietary nitrate supplementation clinically ... Seven-day dietary nitrate supplementation clinically significantly improves basal macrovascular function in postmenopausal women.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36750904/

Nitrate-rich beet juice intake on cardiovascular ... We will investigate the effects of beetroot juice rich in NO3 acutely (800 mg) and during a week with daily doses (400 mg) on blood pressure, heart rate (HR), ...

8. cdnsciencepub.com cdnsciencepub.com/doi/10.1139/cjpp-2024-0061

The acute effects of dietary nitrate supplementation on ... We demonstrate that an acute dose of nitrate-rich beetroot juice enhances endothelial resistance to IR injury in healthy, postmenopausal women at two distinct ...

9. pubs.rsc.org pubs.rsc.org/en/content/articlehtml/2024/fo/d3fo03749e

Increased nitrate intake from beetroot juice over 4 weeks ... Increased nitrate intake from beetroot juice over 4 weeks affects nitrate metabolism, but not vascular function or blood pressure in older ...