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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02593305
Other study ID # 201507735
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2015
Est. completion date April 28, 2017

Study information

Verified date September 2019
Source University of Iowa
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 23
Est. completion date April 28, 2017
Est. primary completion date April 28, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 85 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Super Beets
Nitrate rich beetroot powder (10g/day) for 4 weeks
Super Beets Placebo
Nitrate deficient beetroot powder (10g/day) for 4 weeks

Locations

Country Name City State
United States University of Iowa Iowa City Iowa

Sponsors (2)

Lead Sponsor Collaborator
Darren P Casey Neogenis Laboratories

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults 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. Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.
Primary Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults. 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. Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.
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