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Completed

NCT Number: NCT02593305

Dietary Nitrate and Physiological Aging

The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity, and blood pressure responsiveness to a variety of physiological stressors in older healthy adults. We will also examine the effect of dietary nitrate supplementation on measures of central artery stiffness and aortic blood pressure in older adults. Lastly, we will also recruit a group of young subjects in order to help characterize the age-related changes associated with the physiological outcome measures of the present study.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

1 in 3 adults in the U.S. have hypertension which is known to increase the risk of heart disease and stroke. Blood pressure regulation is mediated by many factors including but not limited to metabolic factors, pressure/stretch sensing receptors located in the aorta and carotid arteries, endothelial cell function, and kidney function (via water and sodium absorption/excretion). It has been shown that many of these regulatory mechanisms are altered and/or become dysfunctional with aging. Specifically older adults commonly demonstrate a decreased sensitivity in pressure receptors and/or endothelial dysfunction. Additionally with aging, there is an increase in sympathetic nervous system activity and arterial stiffness which can contribute to higher blood pressure. The important vasodilator, nitric oxide (NO), has been implicated as a key signaling molecule involved in several of the mechanisms in blood pressure regulation outlined above. A decreased NO production or bioavailability is thought to contribute to several of the physiologic changes that come with aging. Therefore, the overall aim of this study is to use a randomized, double-blind crossover, placebo controlled study to examine the effects of acute dietary nitrate supplementation (to boost bioavailable NO) on various parameters of blood pressure regulation and responsiveness in normal healthy older adults. Our main hypothesis is that 4 weeks of dietary nitrate supplementation will decrease the blood pressure responses in older adults in response to a variety of physiological stressors.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Two separate age groups were included.

Inclusion criteria

  • Healthy young adults 18-35 years of age (comparison group)
  • Healthy older adults 60-85 years of age (intervention group)

Exclusion criteria

  • Hypertension, hyperlipidemia, current smoker or smoker within the last year, heart disease, diabetes, Chronic obstructive pulmonary disease, asthma, sleep apnea, Raynaud's disease, body mass index (BMI) > 30 kg/m2, allergy medication, clinical depression, autonomic disorders and other conditions or medications that might normally alter cardiovascular function, exercise tolerance, and/or blood pressure responses.

Treatment and study plan

Super Beets

Dietary Supplement

Nitrate rich beetroot powder (10g/day) for 4 weeks

Other names: Beetroot crystals

Super Beets Placebo

Dietary Supplement

Nitrate deficient beetroot powder (10g/day) for 4 weeks

Other names: Beetroot crystals no nitrate

Primary outcomes

  1. Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults

    Time frame: Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.

    Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.

  2. Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.

    Time frame: Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.

    Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.

Sponsors and collaborators

Lead sponsor

Darren P Casey

Other

Collaborators

  • Neogenis Laboratories

Registry information

Official study title

Dietary Nitrate Supplementation and Physiological Function in Older Adults

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Nov 2, 2015
Registry last updated
Oct 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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