The Effects of a Dietary Supplement on Exercise Performance in Healthy Older Adults"

University of California, Los Angeles (UCLA)

Status: Completed

Conditions: Excessive Physical Exercise, Unspecified

Treatments: Dietary Supplement: Placebo; Dietary Supplement: Arginine antioxidant supplements

Study type: Interventional

Funder types: Other

Identifiers

NCT01073332

UCLA_IRB_03-08-087-01

Details and patient eligibility

About

Human exercise capacity decreases with aging. One explanation may be that blood vessels stiffen with age and release less of a compound called nitric oxide (NO). This compound normally relaxes blood vessels and increases blood flow to muscles, but damaging compounds called free radicals can interfere with this process. Antioxidants may help prevent free radicals from inactivating nitric oxide. The purpose of this study was to investigate the effects of an antioxidant supplement that supports NO production on exercise performance in elderly male cyclists.

Full description

Since the discovery of the vascular smooth muscle relaxant properties of nitric oxide (NO) over 25 years ago, studies have implicated this molecule in modulating such processes as atherosclerosis, impotence, angina, platelet function, and blood pressure, among others. Through vascular smooth muscle relaxation in both coronary and skeletal muscle arteries, as well as via independent mechanisms, nitric oxide has also been implicated in improvement of exercise capacity. In addition, NO may be involved in the immune system, assist in memory function and sleep regulation, and act as a cellular signaling messenger. Youthful, healthy and athletic individuals generally have a healthier NO system, compared to sedentary, unhealthy and aging individuals. NiteworksTM is a dietary supplement that includes L-arginine, an amino acid that acts as a nitric oxide donor and has been shown to increase levels of this molecule in the body. NiteworksTM has been formulated as a composite mixture along with other supplements, including antioxidants, that may act synergistically with L-arginine in enhancing exercise capacity.

Enrollment: 16 patients

Sex: All

Ages: 50 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Males and females
• Age 50-75 years, inclusive
• Ability to perform pulmonary function and exercise tests
• Willingness to take supplement powder for 3 weeks
• Ethical: Subject must sign the Institutional Review Board-approved written informed consent prior to he initiation of any study specific procedures or randomization. A subject will be excluded for any condition that might compromise the ability to give truly informed consent for participation in the study.

Exclusion criteria

• Existing pulmonary or cardiovascular disease
• Previous cardiac surgery
• Not able to tolerate breathing through mouthpiece for up to 20 minutes
• Musculoskeletal disease that would limit exercise

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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16 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.

Treatment:

Dietary Supplement: Placebo

Arginine antioxidant supplements

Experimental group

Description:

Dietary Supplement: Niteworks

Treatment:

Dietary Supplement: Arginine antioxidant supplements