- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02593305
Dietary Nitrate and Physiological Aging
September 24, 2019 updated by: Darren P Casey
Dietary Nitrate Supplementation and Physiological Function in Older Adults
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Interventional
Enrollment (Actual)
23
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Iowa
-
Iowa City, Iowa, United States, 52242
- University of Iowa
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Beetroot crystals (nitrate), then placebo
Participants will receive a nitrate rich beetroot powder (10g/day) for 4 weeks.
After a washout period of 4 weeks, they will then receive the placebo (beetroot powder, no nitrate) for 4 weeks.
|
Nitrate rich beetroot powder (10g/day) for 4 weeks
Other Names:
Nitrate deficient beetroot powder (10g/day) for 4 weeks
Other Names:
|
Experimental: Placebo, then beetroot crystals (nitrate)
Participants will receive a beetroot powder placebo (no nitrate) for 4 weeks.
After a 4 week washout period, they will receive the nitrate rich beetroot powder for 4 weeks.
|
Nitrate rich beetroot powder (10g/day) for 4 weeks
Other Names:
Nitrate deficient beetroot powder (10g/day) for 4 weeks
Other Names:
|
No Intervention: Young Comparison
Young control group, used for age-related comparisons.
This group did not go through any intervention.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.
|
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.
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Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Darren Casey, PhD., University of Iowa
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2015
Primary Completion (Actual)
April 28, 2017
Study Completion (Actual)
April 28, 2017
Study Registration Dates
First Submitted
October 27, 2015
First Submitted That Met QC Criteria
October 29, 2015
First Posted (Estimate)
November 1, 2015
Study Record Updates
Last Update Posted (Actual)
October 14, 2019
Last Update Submitted That Met QC Criteria
September 24, 2019
Last Verified
September 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Neurotransmitter Uptake Inhibitors
- Membrane Transport Modulators
- Dopamine Agents
- Dopamine Uptake Inhibitors
- Central Nervous System Stimulants
- Sympathomimetics
- Adrenergic Uptake Inhibitors
- Methamphetamine
Other Study ID Numbers
- 201507735
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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