Clinical trial
Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females
Name
HSR210326
Description
Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.
Trial arms
Trial start
2021-11-01
Estimated PCD
2023-04-01
Trial end
2023-04-01
Status
Completed
Phase
Early phase I
Treatment
BEET IT - Concentrate Beet root juice
Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\~6.5 mmol) will be consumed twice daily (totalling \~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.
Arms:
Acute High-Intensity Exercise, Acute Moderate-Intensity Exercise, Non-Exercise Control
Other names:
Dietary Nitrate supplementation (nitrate rich)
BEET IT - Concentrate Beet root juice (nitrate depleted)
Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\~0 mmol) will be consumed twice daily (totalling \~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.
Arms:
Acute High-Intensity Exercise, Acute Moderate-Intensity Exercise, Non-Exercise Control
Other names:
Dietary Nitrate supplementation (nitrate depleted)
Size
24
Primary endpoint
Baseline Flow-Mediated Dilation
Baseline (minute 0).
Post-Exercise/Control Flow-Mediated Dilation (60 minutes)
60 minutes post-baseline.
Post-Exercise/Control Flow-Mediated Dilation (90 minutes)
90 minutes post-baseline.
Post-Exercise/Control Flow-Mediated Dilation (120 minutes)
120 minutes post-baseline.
Post-Exercise/Control Flow-Mediated Dilation (150 min)
150 minutes post-baseline.
Post-Exercise/Control Flow-Mediated Dilation (180 min)
180 minutes post-baseline.
Eligibility criteria
Inclusion Criteria:
* Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
* Greater than age 45 but less than age 75
* Sedentary (does not exercise regularly)
* 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)
* 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.)
* Hysterectomy or oophorectomy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': 'This is a double-blind study, where neither the investigators nor the subjects will know whether the participants are receiving the active supplement or placebo supplement until study conclusion.', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 24, 'type': 'ACTUAL'}}
Updated at
2023-11-30
1 organization
1 product
2 indications
Organization
University of VirginiaProduct
BEET ITIndication
Vascular DilationIndication
Arteriosclerosis