Overview

Nitrite Supplementation for Improving Physiological Function in Older Adults

Status:
Completed
Trial end date:
2019-05-01
Target enrollment:
0
Participant gender:
Female
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, 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.
Phase:
N/A
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
University of Colorado, Boulder
Criteria
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.