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

NCT03380000 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 00043633
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Women

Keywords

Dietary nitrate supplementation; Beetroot juice

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Blood Measures of Nitrate Absorption and Conversion

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

• Resting Arterial Stiffness/Wave Properties

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

• Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)

  Approximately 180 minutes after ingestion of beetroot juice

• Peak Rate of Perceived Exertion Scores During Handgrip Exercise

  Approximately 90 minutes after ingestion of beetroot juice

• Handgrip Exercise Tolerance

  Approximately 90 minutes after ingestion of beetroot juice

Study Arms (2)

Nitrate rich beetroot juice

ACTIVE COMPARATOR

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

Drug: Beetroot juice

Nitrate depleted beetroot juice

PLACEBO COMPARATOR

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

Drug: Beetroot juice placebo

Interventions

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).

Also known as: Beet-It Organic Shot

Nitrate rich beetroot juice

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).

Also known as: Beet-It Organic placebo

Nitrate depleted beetroot juice

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Results Point of Contact

• Title: David N. Proctor
• Organization: Penn State University

dnp3@psu.edu

8145715234

Study Officials

• David N Proctor, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology, Physiology, and Medicine

Study Record Dates

• First Submitted: December 10, 2017
• First Posted: December 20, 2017
• Study Start: September 12, 2014
• Primary Completion: September 1, 2019
• Study Completion: January 1, 2020
• Last Updated: July 12, 2022
• Results First Posted: June 23, 2021

Record last verified: 2022-06

Locations

US (1)