Postmenopausal Women and Their Endothelium

NCT ID: NCT03644472

Last Updated: 2023-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-07
• Study Completion Date: 2023-02-20

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.

Conditions

Postmenopausal Women

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Nitrate rich beetroot juice

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

Group Type: ACTIVE_COMPARATOR

nitrate rich beetroot juice

Intervention Type: DRUG

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

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

Group Type: PLACEBO_COMPARATOR

nitrate depleted beetroot juice

Intervention Type: 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).

Interventions

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).

Intervention Type: DRUG

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).

Intervention Type: DRUG

Other Intervention Names

Beet-It Organic Shot; Beet-it Organic Shot Placebo

Eligibility Criteria

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

• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Penn State University

OTHER

Sponsor Role: lead

Responsible Party

David N. Proctor, PhD

Professor of Kinesiology, Physiology, and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David N Proctor, PhD

Role: PRINCIPAL_INVESTIGATOR

Penn State University

Locations

Penn State University

University Park, Pennsylvania, United States

Countries

United States

References

Delgado Spicuzza JM, Gosalia J, Zhong L, Bondonno C, Petersen KS, De Souza MJ, Alipour E, Kim-Shapiro DB, Somani YB, Proctor DN. Seven-day dietary nitrate supplementation clinically significantly improves basal macrovascular function in postmenopausal women: a randomized, placebo-controlled, double-blind, crossover clinical trial. Front Nutr. 2024 Jun 10;11:1359671. doi: 10.3389/fnut.2024.1359671. eCollection 2024.

Reference Type: DERIVED

PMID: 38915856 (View on PubMed)

Other Identifiers

00010017

Identifier Type: -

Identifier Source: org_study_id