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

The Pennsylvania State University (PENNSTATE) logo

The Pennsylvania State University (PENNSTATE)

Status and phase

Completed
Phase 2

Conditions

Postmenopausal Women

Treatments

Drug: Beetroot juice
Drug: Beetroot juice placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT03380000
00043633

Details and patient eligibility

About

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.

Full description

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.

Enrollment

16 patients

Sex

Female

Ages

55 to 80 years old

Volunteers

Accepts Healthy Volunteers

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:

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

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

16 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice
Active Comparator group
Description:
Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.
Treatment:
Drug: Beetroot juice
Nitrate depleted beetroot juice
Placebo Comparator group
Description:
Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Treatment:
Drug: Beetroot juice placebo

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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