Phase 2 N=16 Randomized Double-blind Basic Science

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

Postmenopausal Women

Bottom Line

View on ClinicalTrials.gov: NCT03380000 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jun 2021

Primary outcome: Primary: Resting Aortic Blood Pressures — 113.3; 116.9 mmHg

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Beetroot juice (Drug); Beetroot juice placebo (Drug)
Age: Adult, Older Adult · 55+ yrs
Sex: Female
Sponsor: Penn State University
Primary completion: Sep 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Resting Aortic Blood Pressures	113.3; 116.9	—
SECONDARY Blood Measures of Nitrate Absorption and Conversion	643.9; 39.2; 0.402; 0.115	—
SECONDARY Resting Arterial Stiffness/Wave Properties	7.328; 7.572	—
SECONDARY Handgrip Exercise Blood Pressure Responses (Relative Change From Baseline)	25; 30	—
SECONDARY Peak Rate of Perceived Exertion Scores During Handgrip Exercise	17.3; 17.7	—
SECONDARY Handgrip Exercise Tolerance	602.8; 541.0	—

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.

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:
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03380000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.