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

NCT01073332 | Completed

• 1 other identifier: UCLA_IRB_03-08-087-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Excessive Physical Exercise, Unspecified

Outcome Measures

Primary Outcomes (1)

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

  3 weeks

Secondary Outcomes (1)

• Arginine and antioxidant Supplements improve maximal oxygen uptake and anaerobic threshold

  3 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Arginine antioxidant supplements

EXPERIMENTAL

Dietary Supplement: Niteworks

Dietary Supplement: Arginine antioxidant supplements

Interventions

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.

Arginine antioxidant supplements

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

Study Officials

• Zhaoping Li, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: February 23, 2010
• Study Start: October 1, 2004
• Primary Completion: February 1, 2005
• Study Completion: February 1, 2005
• Last Updated: May 8, 2015

Record last verified: 2010-02

Locations

US (1)