MedDataX Logo

Effects of Inorganic Nitrate and Intensity of Exercise on Cardiovascular Health in Post-Menopausal Females

NCT ID: NCT05221905

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Post-menopausal females experience elevated cardiovascular disease risk (CVD), compared to premenopausal females and age-matched males. Current exercise guidelines appear inadequate to ameliorate this increased risk and higher intensity exercise may be necessary. Oral inorganic nitrate supplementation enhances both exercise performance and CVD risk profile in several clinical conditions. However, the effects of this intervention in post-menopausal females is unexplored.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The purpose of this study is to determine whether acute inorganic nitrate supplementation and exercising at different exercise intensities (high vs moderate) improve vascular health in post-menopausal females.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Vascular Dilation Arterial Stiffness

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Flow-mediated dilation Pulse wave velocity Exercise intensity Vascular function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subject are stratified randomized to consume either beetroot juice with, or without, inorganic nitrate and will consume this same supplement throughout all testing
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators
This is a double-blind study, where neither the investigators nor the subjects will know whether the participants are receiving the active supplement or placebo supplement until study conclusion.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acute High-Intensity Exercise

Subjects will exercise at an intensity of 75% of the difference between the lactate threshold and VO2peak until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.

Group Type ACTIVE_COMPARATOR

BEET IT - Concentrate Beet root juice

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\~6.5 mmol) will be consumed twice daily (totalling \~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.

BEET IT - Concentrate Beet root juice (nitrate depleted)

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\~0 mmol) will be consumed twice daily (totalling \~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.

Acute Moderate-Intensity Exercise

Subjects will exercise at an intensity at the lactate threshold until 200 kcal are expended. Pre- and post-testing measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, with exercise taking place during time points 0-60 min.

Group Type ACTIVE_COMPARATOR

BEET IT - Concentrate Beet root juice

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\~6.5 mmol) will be consumed twice daily (totalling \~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.

BEET IT - Concentrate Beet root juice (nitrate depleted)

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\~0 mmol) will be consumed twice daily (totalling \~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.

Non-Exercise Control

Measures of vascular health will be completed at baseline (0 min) and again 60, 90, 120, 150, 180 min post-baseline testing, without exercise taking place during time points 0-60 min.

Group Type PLACEBO_COMPARATOR

BEET IT - Concentrate Beet root juice

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\~6.5 mmol) will be consumed twice daily (totalling \~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.

BEET IT - Concentrate Beet root juice (nitrate depleted)

Intervention Type DRUG

Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\~0 mmol) will be consumed twice daily (totalling \~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BEET IT - Concentrate Beet root juice

Beet It Sport (James White Drinks, Ltd.) each containing 400mg of inorganic nitrate (\~6.5 mmol) will be consumed twice daily (totalling \~13 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits.

Intervention Type DRUG

BEET IT - Concentrate Beet root juice (nitrate depleted)

Beet It Sport (James White Drinks, Ltd.) each containing 0mg of inorganic nitrate (\~0 mmol) will be consumed twice daily (totalling \~0 mmol of inorganic nitrate per day) for at least 2 days prior to testing visits, as well as 2 hours prior to testing visits. It is provided by the same company that produces the concentrated beet root juice shots (James White Drinks) but the placebo version is nitrate-depleted.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dietary Nitrate supplementation (nitrate rich) Dietary Nitrate supplementation (nitrate depleted)

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Post-menopausal female, defined as having not had a menstrual cycle for at least 1 year
* Greater than age 45 but less than age 75
* Sedentary (does not exercise regularly)
* No major changes in medication in the last 3 months

Exclusion Criteria

* Smokers within last 5 years
* Weight unstable (loss/gain of more than 3kg in the past 3 months)
* Any medical condition that prevents the subject from exercising safely
* Hormone replacement therapy (current or within last 3 months)
* Currently or recently on vasoactive medications (i.e., calcium channel blockers, statins, ACE or renin inhibitors, ARBs, nitrates, alpha- or beta-blockers, diuretics, proton pump inhibitors, etc.)
* Hysterectomy or oophorectomy
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Virginia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Arthur L Weltman

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Arthur Weltman, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor of Kinesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Student Health and Wellness Center

Charlottesville, Virginia, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

HSR210326

Identifier Type: -

Identifier Source: org_study_id