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

Postmenopausal Women Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03380000
• Other study ID #: 00043633
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2014
• Est. completion date: January 2020

Study information

• Verified date: June 2022
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: January 2020
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Drug:
• 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).
• 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).

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Resting Arterial Stiffness/Wave Properties	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
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.	Approximately 180 minutes after ingestion of beetroot juice
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.	Approximately 90 minutes after ingestion of beetroot juice
Secondary	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