Postmenopausal Women and Their Endothelium

The Pennsylvania State University (PENNSTATE)

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Women

Treatments: Drug: nitrate depleted beetroot juice; Drug: nitrate rich beetroot juice

Study type: Interventional

Funder types: Other

Identifiers

NCT03644472

00010017

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Female

Ages: Under 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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37 participants in 2 patient groups, including a placebo group

Nitrate rich beetroot juice

Active Comparator group

Description:

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

Treatment:

Drug: nitrate rich beetroot juice

Nitrate depleted beetroot juice

Placebo Comparator group

Description:

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

Treatment:

Drug: nitrate depleted beetroot juice