Excessive Physical Exercise, UnspecifiedNCT01073332
The Effects of a Dietary Supplement on Exercise Performance in Healthy Older Adults"
A study testing Arginine antioxidant supplements in people with Excessive Physical Exercise, Unspecified, run by University of California, Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Excessive Physical Exercise, Unspecified
- What is being tested?
- Arginine antioxidant supplements
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2004to Feb 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of California, Los Angeles
Los Angeles, California, 90095
About this study
Official title: Arginine and Antioxidant Supplement on Performance in Elderly Male Cyclists: A Randomized Controlled Trial
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.
Read the detailed 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.
- Conditions
- Excessive Physical Exercise, Unspecified
- Being tested
- Arginine antioxidant supplements, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arginine antioxidant supplementsDietary 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.
PlaceboDietary supplement
The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | The placebo group received a powder with all active ingredients replaced with M-100 maltodextrin. Receives: Dietary Supplement: Placebo |
| Arginine antioxidant supplements | Experimental | Dietary Supplement: Niteworks Receives: Dietary Supplement: Arginine antioxidant supplements |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arginine and antioxidant supplements, as compared with placebo will improve exercise performance
Measured: 3 weeks
Secondary outcomes (1)
Arginine and antioxidant Supplements improve maximal oxygen uptake and anaerobic threshold
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2010 (estimated)
- Study startOct 2004
- Primary completionFeb 2005
- Study completionFeb 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Excessive Physical Exercise, UnspecifiedStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoping Li, University of California, Los Angeles
- Investigators
- Zhaoping Li, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01073332
- Sponsor's protocol ID
- UCLA_IRB_03-08-087-01
- Status last verified
- Feb 2010
- First submitted
- 22 Feb 2010
- Last updated
- 8 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arginine and Antioxidant Supplement on Performance in Elderly Male Cyclists: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01073332
- Acronym / sponsor ID
- UCLA_IRB_03-08-087-01
- Conditions
- Excessive Physical Exercise, Unspecified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Feb 2005 (actual)
- Study completion
- Feb 2005 (actual)
- First posted
- 23 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboThe placebo group received a powder with all active ingredients replaced with M-100 maltodextrin. |
| Arginine antioxidant supplements | Experimental | Dietary Supplement: Arginine antioxidant supplementsDietary Supplement: Niteworks |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arginine antioxidant supplementsThe 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. | Dietary supplement | Arginine antioxidant supplements |
| PlaceboThe placebo group received a powder with all active ingredients replaced with M-100 maltodextrin. | Dietary supplement | Placebo |
Primary outcome
Arginine and antioxidant supplements, as compared with placebo will improve exercise performance
Time frame: 3 weeks
1 secondary outcome
Arginine and antioxidant Supplements improve maximal oxygen uptake and anaerobic threshold
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zhaoping Li, MD, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine antioxidant supplements in people with Excessive Physical Exercise, Unspecified, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arginine and antioxidant supplements, as compared with placebo will improve exercise performance (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2015.