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Completed

NCT Number: NCT03380000

Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women

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.

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Key information

Conditions

Postmenopausal Women

Age range

55 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Penn State University

University Park, Pennsylvania, 16802, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Resting systolic blood pressure less than or equal to 160 mmHg
  • Resting diastolic blood pressure less than or equal to 100 mmHg

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:
  • blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
  • lipid-lowering medication (e.g., statins)
  • nitrates (e.g. nitroglycerin) for angina
  • phosphodiesterase inhibitors (e.g., Viagra)
  • anti-inflammatory drugs
  • Individuals currently taking hormone replacement therapy

Treatment and study plan

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).

Other names: Beet-It Organic Shot

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).

Other names: Beet-It Organic placebo

Primary outcomes

  1. Resting Aortic Blood Pressures

    Time frame: Resting systolic blood pressure at 90 minutes after beetroot juice ingestion

    Aortic Blood pressures were measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).

Secondary outcomes

  1. Blood Measures of Nitrate Absorption and Conversion

    Time frame: Change from baseline measures of plasma nitrate and nitrite at 90 minutes and at approximately 6 hours

    Venous blood will be withdrawn (venipuncture) for determination of plasma nitrate and nitrite.

  2. Resting Arterial Stiffness/Wave Properties

    Time frame: Change from baseline resting pulse wave velocity at 90 minutes after beet root juice ingestion

    Carotid to femoral artery pulse wave velocity will be assessed using arterial tonometry.

  3. Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)

    Time frame: Approximately 180 minutes after ingestion of beetroot juice

    Beat-to-beat blood pressure (finger cuff) will be assessed at rest and during handgrip exercise to volitional fatigue.

  4. Peak Rate of Perceived Exertion Scores During Handgrip Exercise

    Time frame: Approximately 90 minutes after ingestion of beetroot juice

    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.

  5. Handgrip Exercise Tolerance

    Time frame: Approximately 90 minutes after ingestion of beetroot juice

    Time to fatigue (seconds) was assessed during a progressive blood flow restricted handgrip exercise protocol.

Sponsors and collaborators

Lead sponsor

Penn State University

Other

Registry information

Official study title

Acute Blood Pressure-lowering Effects of Beetroot Juice in Postmenopausal Women With and Without Hypertension

Important dates

Study start
2014
Primary completion
2019
Study completion
2020
First posted
Dec 20, 2017
Registry last updated
Jul 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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