HealthyLitmusMagnetNCT00813553
Effect of β-alanine Supplementation on Muscle Carnosine
A study testing beta-alanine in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
Trial summary
Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle. Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- beta-alanine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2008to Oct 2009
- 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 18 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Stable health as evaluated by medical evaluation
- Body mass index higher than 18 kg/m2
- Body mass index lower than 25 kg/m2, unless body fat is less than 20%
Who cannot join
- intolerance to β-alanine,
- allergy to soy, fish and crustacean
- participation in another intervention study
- consumer of dietary supplement susceptible to contain beta-alanine
- determined to have very high baseline muscle carnosine concentration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Two 8-week β-alanine Supplementation Protocols on Muscle Carnosine
Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle.
Read the detailed description
Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain beta-alanine at different doses, the third supplement is a placebo.
- Conditions
- Healthy
- Being tested
- placebo, beta-alanine
- Keywords
- physical fitness, exercise, amino acid
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDietary supplement
daily
beta-alanineDietary supplement
daily
beta-alanineDietary supplement
daily
| Study group | Role | What they receive |
|---|---|---|
| beta-alanine 0 | Placebo comparator | Not described Receives: Dietary Supplement: placebo |
| beta-alanine 1 | Experimental | Not described Receives: Dietary Supplement: beta-alanine |
| beta-alanine 2 | Experimental | Not described Receives: Dietary Supplement: beta-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
muscle carnosine concentration
Measured: 0 to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionOct 2009
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Société des Produits Nestlé (SPN)The 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Bern, Insel Gruppe AG, University Hospital Bern
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00813553
- Sponsor's protocol ID
- 08.13.PER
- Acronym
- LitmusMagnet
- Status last verified
- Apr 2012
- First submitted
- 22 Dec 2008
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Two 8-week β-alanine Supplementation Protocols on Muscle Carnosine
- ClinicalTrials.gov ID
- NCT00813553
- Acronym / sponsor ID
- LitmusMagnet / 08.13.PER
- Conditions
- Healthy
- Keywords
- physical fitness, exercise, amino acid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Collaborators
- University of Bern, Insel Gruppe AG, University Hospital Bern
- Study start
- Dec 2008
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 23 Dec 2008 (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.
Carnosine is a natural acid buffering substance of muscle. The primary objective of this study is to test whether a nutritional supplement of beta-alanine enhances carnosine content in muscle.
Detailed description
Volunteers will be randomized to receiving 3 nutritional supplements. Two supplements contain beta-alanine at different doses, the third supplement is a placebo.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| beta-alanine 0 | Placebo comparator | Dietary Supplement: placebo |
| beta-alanine 1 | Experimental | Dietary Supplement: beta-alanine |
| beta-alanine 2 | Experimental | Dietary Supplement: beta-alanine |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Stable health as evaluated by medical evaluation
- Body mass index higher than 18 kg/m2
- Body mass index lower than 25 kg/m2, unless body fat is less than 20%
Key exclusion criteria (5 listed)
- intolerance to β-alanine,
- allergy to soy, fish and crustacean
- participation in another intervention study
- consumer of dietary supplement susceptible to contain beta-alanine
- determined to have very high baseline muscle carnosine concentration
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 |
|---|---|---|
| placebodaily | Dietary supplement | beta-alanine 0 |
| beta-alaninedaily | Dietary supplement | beta-alanine 1 |
| beta-alaninedaily | Dietary supplement | beta-alanine 2 |
Primary outcome
muscle carnosine concentration
Time frame: 0 to 8 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 25 Apr 2012.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing beta-alanine in people with Healthy, run by Société des Produits Nestlé (SPN) at 1 site in Switzerland.
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 3 inclusion and 5 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 25 Apr 2012. 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 Switzerland. 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?
muscle carnosine concentration (time frame: 0 to 8 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 25 Apr 2012.