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

This study has been completed.
Sponsor:
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT01073332
First received: February 22, 2010
Last updated: NA
Last verified: February 2010
History: No changes posted
  Purpose

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.


Condition Intervention
Exercise
Dietary Supplement: Arginine antioxidant supplements

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Arginine and Antioxidant Supplement on Performance in Elderly Male Cyclists: A Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Arginine and antioxidant supplements, as compared with placebo will improve exercise performance [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Arginine and antioxidant Supplements improve maximal oxygen uptake and anaerobic threshold [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: October 2004
Study Completion Date: February 2005
Primary Completion Date: February 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Placebo
The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.
Dietary Supplement: Arginine antioxidant supplements
The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.
Experimental: Arginine antioxidant supplements Dietary Supplement: Arginine antioxidant supplements
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.

  Eligibility

Ages Eligible for Study:   50 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01073332

Locations
United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Zhaoping Li, MD, PhD, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT01073332     History of Changes
Other Study ID Numbers: UCLA_IRB_03-08-087-01
Study First Received: February 22, 2010
Last Updated: February 22, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents

ClinicalTrials.gov processed this record on October 23, 2014