Postmenopausal Women and Their Endothelium

Postmenopausal Women Clinical Trial

Official title:

Postmenopausal Women and Their Endothelium: Is Dietary Nitrate Supplementation Protective

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03644472
• Other study ID #: 00010017
• Status: Completed
• Phase: Phase 2
• Start date: November 7, 2018
• Est. completion date: February 20, 2023

Study information

• Verified date: February 2023
• Source: Penn State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: February 20, 2023
• Est. primary completion date: February 20, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Postmenopausal Women

Intervention

Drug:
• nitrate rich 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).
• nitrate depleted beetroot juice
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).

Locations

Country	Name	City	State
United States	Penn State University	University Park	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Penn State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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
Primary	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.	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
Secondary	Resting blood pressures	Resting systolic blood pressures will be measured in the arm (cuff) and estimated in the aorta (radial artery tonometry).	Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion
Secondary	Recovery of micro-vascular function and brachial artery flow mediated dilation	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.	Change in these measures from immediately after ischemia-reperfusion injury to 30 minutes following
Secondary	Brachial artery flow-mediated dilation	Using doppler ultrasound the brachial artery diameter will be measured before and after 5 minutes of forearm cuff occlusion	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
Secondary	Brachial ankle pulse wave velocity and ankle-brachial index	Using the VP-Colin 2000 brachial ankle pulse wave velocity and ankle brachial index will be measured before and after supplementation	These measurements will take place before (day 1) and 24 hours after (day 8) 7 days of supplementation.