Postmenopausal Women and Their Endothelium

Phase 2

Completed

• Conditions: Postmenopausal Women
• Interventions: Drug: nitrate depleted beetroot juice; Drug: nitrate rich beetroot juice

• Registration Number: NCT03644472
• Lead Sponsor: Penn State University

Brief Summary

The purpose of this study is to test the effects of a one time dose and 7-days of inorganic nitrate (supplied in the form of beetroot juice) on blood vessel function and resting blood pressure in healthy, postmenopausal women. Participants will drink beetroot juice and a placebo juice on separate visits where blood pressure and blood vessel function will be measured.

Detailed Description

Cardiovascular disease is the leading cause of death in the United States. Due to the loss of estrogen, women experience a unique accelerated rise in cardiovascular disease risk factors following menopause. Postmenopausal women represent a population at heightened risk for cardiovascular disease development. Function of the endothelium has been shown to decline across the menopause transition, resulting in less production of nitric oxide. As such the investigators are investigating a potential therapeutic strategy in women have recently undergone menopause to boost nitric oxide availability.

Study Timeline

• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Study Start: 2018-11-07
• Status Verified: 2023-02
• Primary Completion: 2023-02-20
• Study Completion: 2023-02-20
• Last Update Submitted: 2023-02-23
• Last Update Posted: 2023-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 37

Inclusion Criteria

• Early post-menopausal women who are within 1-6 years following their final menstrual cycle
• Late post-menopausal women who are beyond 6 years following their final menstrual cycle

Exclusion Criteria

• Individuals with any 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)

• Individuals with a BMI > 35

• Individuals with resting blood pressure > or = 130/80 mm Hg

• Individuals with high blood lipids (total cholesterol > or = 240 mg/dl, LDL > or = 160 mg/dl, triglycerides > or = 200 mg/dl).

• Postmenopausal women with hyperglycemia (fasting glucose > or = 110 mg/dl and HbA1c >6.0%).

• Individuals 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 taking hormone therapy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Nitrate depleted beetroot juice	nitrate depleted beetroot juice	Subjects will consume 140 ml of beetroot juice (Beet-It Organic Placebo) approximately 90 min before physiological testing.
Nitrate rich beetroot juice	nitrate rich beetroot juice	Subjects will consume 140 ml of beetroot juice (Beet-It Organic Shot) approximately 90 min before physiological testing.

Primary Outcome Measures

Name	Time	Method
Micro-vascular reactivity	These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in micro-vascular reactivity	Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure area under the curve for tissue saturation index re-perfusion following 5 minutes of forearm cuff occlusion.
Macro-vascular reactivity	These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in macro-vascular reactivity	Using near-infrared spectroscopy, a probe placed on the forearm muscle will be used to measure the tissue saturation index re-perfusion slope following 5 minutes of forearm cuff occlusion.

Secondary Outcome Measures

Name	Time	Method
Brachial artery flow-mediated dilation	These measurements will take place before and after a ischemia-reperfusion injury (20 minutes inflation, 20 minutes deflation) induced in the upper arm to assess change in brachial artery flow-mediated dilation	Using doppler ultrasound the brachial artery diameter will be measured before and after 5 minutes of forearm cuff occlusion
Resting blood pressures	Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion	Resting systolic blood pressures will be measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).
Recovery of micro-vascular function and brachial artery flow mediated dilation	Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following	Micro-vascular and brachial artery flow-mediated dilation, as described above, will be reassessed 30 minutes following ischemia-reperfusion injury to determine recovery of vessel function.
Brachial ankle pulse wave velocity and ankle-brachial index	These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.	Using the VP-Colin 2000 brachial ankle pulse wave velocity and ankle brachial index will be measured before and after supplementation

Trial Locations

Locations (1)

Penn State University; 🇺🇸 University Park, Pennsylvania, United States