Nitrite Supplementation for Improving Physiological Function in Older Adults

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

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2019-05-31

Brief Summary

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

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nitrate Supplementation and Muscle Blood Flow

NCT03459027

Vasodilation Blood Pressure Active Hyperemia +1 more

COMPLETED NA

Nitrite Infusion Studies

NCT00102271

Healthy

COMPLETED PHASE1

Dietary Nitrate and Nitrite to Increase Nitric Oxide in Patients With Coronary Artery Disease

NCT00069654

Coronary Arteriosclerosis

COMPLETED PHASE2

Pilot Study On The Role Of Nitric Oxide In Alpha 1-Adrenergic Vasoreactivity

NCT00240058

Blood Pressure

COMPLETED NA

Role of Acetylcholine in Blood Flow Regulation in Healthy Adults: Effects of Age and Exercise Training

NCT03972683

Vasoconstriction Vasodilation

WITHDRAWN EARLY_PHASE1

Detailed Description

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

Conditions

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

Ageing

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

Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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

Sodium Nitrite Supplementation

80 mg/day (40 mg 2x/day) slow release sodium nitrite (TheraVasc, Inc) for 3 months

Group Type EXPERIMENTAL

Sodium nitrite

Intervention Type DRUG

Placebo

placebo 2x/day for 3 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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

Sodium nitrite

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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

Inclusion Criteria

* • 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)

Exclusion Criteria

* • 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.
* 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.

Minimum Eligible Age

60 Years

Maximum Eligible Age

79 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes