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

NCT ID: NCT03380000

Last Updated: 2022-07-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-09-12
• Study Completion Date: 2020-01-31

Brief 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.

Detailed 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.

Conditions

Postmenopausal Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Nitrate rich beetroot juice

Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.

Group Type: ACTIVE_COMPARATOR

Beetroot juice

Intervention Type: DRUG

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

Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.

Group Type: PLACEBO_COMPARATOR

Beetroot juice placebo

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Beet-It Organic Shot; Beet-It Organic placebo

Eligibility Criteria

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

David N. Proctor, PhD

Professor of Kinesiology, Physiology, and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David N Proctor, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

00043633

Identifier Type: -

Identifier Source: org_study_id