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OpenTrials
Completed

NCT Number: NCT01073332

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

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.

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Key information

Age range

50 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Arginine antioxidant supplements

Dietary Supplement

The proprietary supplement Niteworks® was manufactured by Herbalife International Inc. (Century City, California, USA). Each serving contained 5.2g L-arginine in a proprietary blend with L-citrulline, 500mg ascorbic acid, 400IU vitamin E, 400ug folic acid, 300mg L-taurine, and 10mg alpha lipoic acid in a lemon-flavored powder form. One serving of supplement powder was mixed with 8 oz of water, administered at bedtime based on the rationale that nitric oxide levels are lowest during sleep due to inactivity, lack of food and low blood pressure.

Placebo

Dietary Supplement

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

Primary outcomes

  1. Arginine and antioxidant supplements, as compared with placebo will improve exercise performance

    Time frame: 3 weeks

Secondary outcomes

  1. Arginine and antioxidant Supplements improve maximal oxygen uptake and anaerobic threshold

    Time frame: 3 weeks

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Registry information

Official study title

Arginine and Antioxidant Supplement on Performance in Elderly Male Cyclists: A Randomized Controlled Trial

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Feb 23, 2010
Registry last updated
May 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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