Postmenopausal Women and Their Endothelium

NCT03644472 | Completed Phase 2 FDA Drug

• 1 other identifier: 00010017
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Postmenopausal Women

Keywords

dietary nitrate supplementation; beetroot juice

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (4)

• Resting blood pressures

  Change from baseline resting blood pressure and at 90 minutes after beet root juice ingestion

• 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

• 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

• 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.

Study Arms (2)

Nitrate rich beetroot juice

ACTIVE COMPARATOR

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

Drug: nitrate rich beetroot juice

Nitrate depleted beetroot juice

PLACEBO COMPARATOR

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

Drug: nitrate depleted beetroot juice

Interventions

nitrate rich beetroot juice DRUG

This beverage contains 0.3 g of inorganic nitrate per 70 ml container, and is bottled and supplied by James White Drinks (UK).

Also known as: Beet-It Organic Shot

Nitrate rich beetroot juice

nitrate depleted beetroot juice 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).

Also known as: Beet-it Organic Shot Placebo

Nitrate depleted beetroot juice

Eligibility Criteria

• Age: Up to 70 Years
• Gender Eligibility Details: Postmenopausal women assigned as female at birth
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• 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 taking hormone therapy

Sponsors & Collaborators

• Penn State University: lead

Study Sites (1)

Penn State University

University Park, Pennsylvania, 16802, United States

Location

Related Publications (1)

• 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.

  PMID: 38915856 DERIVED

Study Officials

• David N Proctor, PhD

  Penn State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Kinesiology, Physiology, and Medicine

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 23, 2018
• Study Start: November 7, 2018
• Primary Completion: February 20, 2023
• Study Completion: February 20, 2023
• Last Updated: February 27, 2023

Record last verified: 2023-02

Locations

US (1)