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AgeingNITRITENCT02393742

Nitrite Supplementation for Improving Physiological Function in Older Adults

A study testing Sodium nitrite in people with Ageing, run by University of Colorado, Boulder at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes reductions in vascular, movement ("motor") and cognitive functions. This study will determine if daily oral supplementation (3 months) with a compound that increases NO in the body, i.e., sodium nitrite, improves vascular… Read more about this study

Who is it for?
Ages 60 to 79 years, women onlyHealthy volunteers can take part
Conditions the study is for
Ageing
What is being tested?
Sodium nitrite
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
49 participants
Where
1 siteUnited States
Study dates
Mar 2015to May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 79 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • • Age 60-79 years. Women will be confirmed as postmenopausal (either natural or surgical) based on cessation of menses for >1 year.
  • Ability to provide informed consent
  • Score >22 on the mini mental state exam (MMSE) to allow a broad range of normal and mildly-impaired cognitive abilities, but function adequate to understand and complete trials (214)
  • Baseline brachial flow-mediated dilation (FMD) < 7%Δ (rationale: non-invasive screening to ensure exclusion of subjects with exceptionally high baseline endothelial function(215))
  • Blood pressure (BP) >100/60 mmHg for past 3 mo (rationale: blood pressure below 100/60 mmHg may elevate the normally small risk of hypotension with sodium nitrite treatment)
  • Ability to perform motor and cognitive tests (e.g., can rise from a chair, walk for 2 min, climb 10 stairs)
  • Willing to accept random assignment to condition (older adults)

Who cannot join

  • • High dietary nitrate intake or current nitrite supplementation; hypersensitivity to nitrates or nitrites
  • Glucose-6-phosphate dehydrogenase deficiency or blood methemoglobin >2%
  • Current smoking
  • Having past or present alcohol dependence or abuse, as defined by the American Psychiatry Association, Diagnostic and Statistical Manual of Mental Disorders
  • Body mass index (BMI) >40 kg/m2 (FMD measurements can be inaccurate in severely obese patients)
  • Chronic clinical diseases (e.g., coronary artery/peripheral artery/cerebrovascular diseases, diabetes, chronic kidney disease requiring dialysis, neurological disorders or diseases that may affect motor/cognitive functions [multiple sclerosis, Parkinson's disease, polio, Alzheimer's disease, dementia or other brain diseases of aging]), except hypertension and hyperlipidemia.
Show all 12Show fewer
  • Regular vigorous aerobic/endurance exercise (>3 vigorous bouts/week)
  • Not weight stable in the prior 3 months (>2 kg weight change) or unwilling to remain weight stable throughout study (rationale: recent weight change or weight loss can influence vascular function and small metabolite signature(216))
  • Current treatment or recent cessation (< 3 mo) of hormone replacement therapy.
  • Moderate or severe peripheral artery disease (ankle-brachial index <0.7)(183)
  • A graded exercise test will be performed by all subjects, if there is physician concern or an adverse event, the subject will not participate in a maximal oxygen consumption test (this will be determined in accordance with stated contraindications for exercise testing provided by the American Heart Association)(217)
  • Claustrophobia, metal implants, etc., affecting feasibility and/or safety of the fMRI scanning.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Clinical Translational Research Center

    Boulder, Colorado, 80309

Other trials in United States

About this study

Official title: Efficacy of Oral Sodium Nitrite for Improving Physiological Functions in Older Adults

Nitric oxide (NO) is an essential molecule in the body that decreases with aging and causes reductions in vascular, movement ("motor") and cognitive functions. This study will determine if daily oral supplementation (3 months) with a compound that increases NO in the body, i.e., sodium nitrite, improves vascular, motor and cognitive function in older adults. The project also seeks to provide insight into the biological reasons (mechanisms) by which supplementation with sodium nitrite improves physiological function in older adults. Overall, this research will provide scientific evidence supporting the use of sodium nitrite for preserving physiological function and preventing clinical disease and disability with aging.

Conditions
Ageing
Being tested
Sodium nitrite, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Sodium nitriteDrug

  • PlaceboDrug

Study groups in NCT02393742
Study groupRoleWhat they receive
Sodium Nitrite SupplementationExperimental80 mg/day (40 mg 2x/day) slow release sodium nitrite (TheraVasc, Inc) for 3 months
Receives: Drug: Sodium nitrite
PlaceboPlacebo comparatorplacebo 2x/day for 3 months
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Vascular Function

    flow mediated dilation

    Measured: 3 months

  2. Motor Function

    rate of torque development

    Measured: 3 months

Secondary outcomes (5)

  1. Systemic oxidative stress and inflammation

    circulating markers of oxidative stress and inflammation

    Measured: 3 months

  2. Number of participants with additional measures of motor ability

    tests of balance, endurance, strength, and dexterity

    Measured: 3 months

  3. endothelial cell oxidative stress and inflammation

    inflammatory and oxidative stress markers in biopsied endothelial cells

    Measured: 3 months

  4. plasma metabolites

    Measured: 3 months

  5. NIH Toolbox cognition test battery

    Cognitive Function

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startMar 2015
  3. Primary completionMay 2019
  4. Study completionMay 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
49 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02393742
Sponsor's protocol ID
R01AG013038-19
Acronym
NITRITE
Status last verified
Dec 2019
First submitted
13 Mar 2015
Last updated
5 Dec 2019
Results posted
No
Data monitoring committee
No

Publications

  • Rossman MJ, Gioscia-Ryan RA, Santos-Parker JR, Ziemba BP, Lubieniecki KL, Johnson LC, Poliektov NE, Bispham NZ, Woodward KA, Nagy EE, Bryan NS, Reisz JA, D'Alessandro A, Chonchol M, Sindler AL, Seals DR. Inorganic Nitrite Supplementation Improves Endothelial Function With Aging: Translational Evidence for Suppression of Mitochondria-Derived Oxidative Stress. Hypertension. 2021 Apr;77(4):1212-1222. doi: 10.1161/HYPERTENSIONAHA.120.16175. Epub 2021 Mar 1.

    PubMed 33641356

  • Jones AM, Vanhatalo A, Seals DR, Rossman MJ, Piknova B, Jonvik KL. Dietary Nitrate and Nitric Oxide Metabolism: Mouth, Circulation, Skeletal Muscle, and Exercise Performance. Med Sci Sports Exerc. 2021 Feb 1;53(2):280-294. doi: 10.1249/MSS.0000000000002470.

    PubMed 32735111

Questions about this trial

What is this clinical trial studying?

A study testing Sodium nitrite in people with Ageing, run by University of Colorado, Boulder at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Vascular Function (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02393742, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2019.

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