Exercise Training Intensity and Nitrate Supplementation in Post-Menopausal Females

University of Virginia

Status: Enrolling

Conditions: Menopause

Treatments: Behavioral: High Intensity Exercise; Behavioral: Moderate Intensity Exercise; Dietary Supplement: Nitrate-Depleted Placebo Beetroot Juice; Dietary Supplement: Nitrate-Rich Beetroot Juice

Study type: Interventional

Funder types: Other

Identifiers

NCT06480695

HSR231665

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 4 patient groups, including a placebo group

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

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Nitrate-Rich Beetroot Juice

Behavioral: High Intensity Exercise

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

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nitrate-Depleted Placebo Beetroot Juice

Behavioral: High Intensity Exercise

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

Active Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nitrate-Rich Beetroot Juice

Behavioral: Moderate Intensity Exercise

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

Placebo Comparator group

Description:

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.

Treatment:

Dietary Supplement: Nitrate-Depleted Placebo Beetroot Juice

Behavioral: Moderate Intensity Exercise