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In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.
Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP) responses during exercise compared with either premenopausal women or men of similar age. Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. Previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising BP responses in older adults. However, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). Thus, the potential BP lowering effects of nitrate supplementation per se have not been established in postmenopausal women. The present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nitrate rich beetroot juice | Active Comparator | Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. |
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| Nitrate depleted beetroot juice | Placebo Comparator | Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Beetroot juice | Drug | This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). |
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| Measure | Description | Time Frame |
|---|---|---|
| Resting Aortic Blood Pressures | Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry). | Resting systolic blood pressure at 90 minutes after beetroot juice ingestion |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Measures of Nitrate Absorption and Conversion | Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate and nitrite. | Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hours |
| Resting Arterial Stiffness/Wave Properties |
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Inclusion Criteria:
Exclusion Criteria:
Overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
Body mass index greater than 35
Total cholesterol greater than 239 mg/dl
LDL cholesterol greater than 159 mg/dl
Fasting blood triglycerides greater than 199 mg/dl
Fasting blood glucose greater than 109 mg/dl and HbA1c greater than 6.0%
Individuals currently taking any of the following medications:
Individuals currently taking hormone replacement therapy
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| Name | Affiliation | Role |
|---|---|---|
| David N Proctor, PhD | Penn State University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State University | University Park | Pennsylvania | 16802 | United States |
16 of 20 participants were randomized. Of those not randomized, 3 did not meet inclusion criteria and 1 withdrew after the familiarization visit.
20 healthy postmenopausal women were screened for eligibility between October 15, 2013 and January 1, 2020 at State College community in State College, PA.
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| ID | Title | Description |
|---|---|---|
| FG000 | Nitrate Depleted Beetroot Juice First, Then Nitrate Rich Beetroot Juice | Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). |
| FG001 | Nitrate Rich Beetroot Juice First, Then Nitrate Depleted Beetroot Juice | Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (1day) |
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| Washout (>7days) |
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| Second Intervention (1day) |
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This was a crossover study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized, Nitrate-rich or -Depleted Beetroot Juice on Two Separate Days | Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. Nitrate-rich Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). Nitrate-depleted Beetroot juice (placebo): This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Resting Aortic Blood Pressures | Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry). | This was a crossover study where the same group of subjects was intervened with both nitrate-rich beetroot juice and nitrate depleted beetroot juice | Posted | Mean | Standard Error | mmHg | Resting systolic blood pressure at 90 minutes after beetroot juice ingestion |
|
4 years
not different from the clinicaltrials.gov definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Randomized, Nitrate Rich Beetroot Juice | Subjects consumed 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing. Beetroot juice: This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David N. Proctor | Penn State University | 8145715234 | dnp3@psu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 16, 2018 | Feb 5, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 16, 2018 | Feb 5, 2021 | ICF_001.pdf |
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Treatment order will be randomly assigned to participants by Clinical Research Center (CRC) staff using computer-based mathematical software. The generated list that determines each participants treatment order will be kept in a secure location in the CRC which cannot be accessed directly by research team members.
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| Beetroot juice placebo | Drug | This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). |
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Carotid to femoral artery pulse wave velocity will be assessed using arterial tonometry. |
| Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestion |
| Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline) | Beat-to-beat blood pressure (finger cuff) will be assessed at rest and during handgrip exercise to volitional fatigue. | Approximately 180 minutes after ingestion of beetroot juice |
| Peak Rate of Perceived Exertion Scores During Handgrip Exercise | The Borg Rating of Perceived Exertion Scale (RPE) was used to assess exercise intensity during handgrip exercise. The RPE scale ranges from a minimum of 6 (no exertion at all) to a maximum of 20 (maximal exertion) units on a scale. | Approximately 90 minutes after ingestion of beetroot juice |
| Handgrip Exercise Tolerance | Time to fatigue (seconds) was assessed during a progressive blood flow restricted handgrip exercise protocol. | Approximately 90 minutes after ingestion of beetroot juice |
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| Participants |
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| Age, Continuous | Mean | Standard Deviation | year |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Mean arterial pressure | Mean | Full Range | mmHg |
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Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). |
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| Secondary | Blood Measures of Nitrate Absorption and Conversion | Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate and nitrite. | This study is a crossover study. Same subjects for nitrate-rich beetroot juice were intervened for nitrate-depleted beetroot juice. | Posted | Mean | Standard Error | uM | Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hours |
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| Secondary | Resting Arterial Stiffness/Wave Properties | Carotid to femoral artery pulse wave velocity will be assessed using arterial tonometry. | Posted | Mean | Standard Error | m/s | Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestion |
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| Secondary | Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline) | Beat-to-beat blood pressure (finger cuff) will be assessed at rest and during handgrip exercise to volitional fatigue. | Posted | Mean | Standard Error | percentage of change from baseline | Approximately 180 minutes after ingestion of beetroot juice |
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| Secondary | Peak Rate of Perceived Exertion Scores During Handgrip Exercise | The Borg Rating of Perceived Exertion Scale (RPE) was used to assess exercise intensity during handgrip exercise. The RPE scale ranges from a minimum of 6 (no exertion at all) to a maximum of 20 (maximal exertion) units on a scale. | Posted | Mean | Standard Deviation | units on a scale | Approximately 90 minutes after ingestion of beetroot juice |
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| Secondary | Handgrip Exercise Tolerance | Time to fatigue (seconds) was assessed during a progressive blood flow restricted handgrip exercise protocol. | Posted | Mean | Standard Deviation | seconds | Approximately 90 minutes after ingestion of beetroot juice |
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| 13 |
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| EG001 | Randomized, Nitrate Depleted Beetroot Juice | Subjects consumed 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing. Beetroot juice placebo: This beverage is identical in look and taste to the Beet-It organic shot, but has the nitrate removed. It is also bottled and supplied by James White Drinks (UK). | 0 | 13 | 0 | 13 | 0 | 13 |
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