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

• ClinicalTrials.gov Identifier: NCT03380000
• Recruitment Status: Active, not recruiting
• First Posted: December 20, 2017
• Results First Posted: June 23, 2021
• Last Update Posted: June 23, 2021
• Sponsor: Penn State University
• Information provided by (Responsible Party): David N. Proctor, PhD, Penn State University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Postmenopausal Women	Drug: Beetroot juice; Drug: Beetroot juice placebo	Phase 2

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 16 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Masking Description: 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.
• Primary Purpose: Basic Science
• Official Title: Acute Blood Pressure-lowering Effects of Beetroot Juice in Postmenopausal Women With and Without Hypertension
• Actual Study Start Date: September 12, 2014
• Actual Primary Completion Date: September 2019
• Estimated Study Completion Date: September 2021

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Nitrate rich beetroot juice; Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.	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).; Other Name: Beet-It Organic Shot
Placebo Comparator: Nitrate depleted beetroot juice; Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.	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).; Other Name: Beet-It Organic placebo

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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 [ 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. Handgrip Exercise Tolerance [ Time Frame: Approximately 180 minutes after ingestion of beetroot juice ]
   Ratings of perceived exertion and time to fatigue will be assessed during a progressive blood flow restricted handgrip exercise protocol.

Eligibility Criteria

• Ages Eligible for Study: 55 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, Pennsylvania

Penn State University

University Park, Pennsylvania, United States, 16802

Sponsors and Collaborators

Penn State University

Investigators

• Principal Investigator: David N Proctor, PhD; Penn State University

  Study Documents (Full-Text)

Documents provided by David N. Proctor, PhD, Penn State University:

Study Protocol and Statistical Analysis Plan  [PDF] July 16, 2018

Informed Consent Form  [PDF] July 16, 2018

More Information

• Responsible Party: David N. Proctor, PhD, Professor of Kinesiology, Physiology, and Medicine, Penn State University
• ClinicalTrials.gov Identifier: NCT03380000
• Other Study ID Numbers: 00043633
• First Posted: December 20, 2017
• Results First Posted: June 23, 2021
• Last Update Posted: June 23, 2021
• Last Verified: May 2021

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by David N. Proctor, PhD, Penn State University:

Dietary nitrate supplementation; Beetroot juice