Oxidative StressNCT00721708
Pharmacokinetics of Carnosine
A study testing pure carnosine, Beef and Chicken in people with Oxidative Stress, run by Tufts University at 1 site in United States.
Trial summary
The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults. Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- pure carnosine, Beef and Chicken
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2007to Jul 2008
- 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 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adult
- normal hematological parameters, normal serum albumin, normal liver function, normal kidney function
Who cannot join
- History of smoking or alcoholism
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA-Human Nutrition Research Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.
- Conditions
- Oxidative Stress
- Being tested
- pure carnosine, Beef, Chicken, Chicken broth
- Keywords
- histidine dipeptides, carnosine, anserine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pure carnosineDietary supplement
one time dose of pure carnosine (450 mg)
BeefOther
one time dose, 150 g of beef
ChickenOther
One time dose, 150g of chicken breast
Chicken brothOther
one time dose of chicken broth obtained from 150g of chicken breast
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Carnosine(450 mg) Receives: Dietary Supplement: pure carnosine |
| 2 | Experimental | Beef (150g) Receives: Other: Beef |
| 3 | Experimental | chicken (150g) Receives: Other: Chicken |
| 4 | Experimental | Chicken broth (obtained from 150 g of chicken breast) Receives: Other: Chicken broth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma histidine-dipeptide
Measured: 0, 30, 60, 100, 180, 240, & 300 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2008 (estimated)
- Study startApr 2007
- Primary completionOct 2007
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- 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
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Investigators
- Kyung-Jin Yeum, Ph.D., Principal investigator, Tufts Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00721708
- Sponsor's protocol ID
- TMC/TUHS IRB 7737
- Status last verified
- Dec 2009
- First submitted
- 22 Jul 2008
- Last updated
- 15 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Yeum KJ, Orioli M, Regazzoni L, Carini M, Rasmussen H, Russell RM, Aldini G. Profiling histidine dipeptides in plasma and urine after ingesting beef, chicken or chicken broth in humans. Amino Acids. 2010 Mar;38(3):847-58. doi: 10.1007/s00726-009-0291-2. Epub 2009 Apr 19.
PubMed 19381778
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Carnosine
- ClinicalTrials.gov ID
- NCT00721708
- Acronym / sponsor ID
- TMC/TUHS IRB 7737
- Conditions
- Oxidative Stress
- Keywords
- histidine dipeptides, carnosine, anserine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 24 Jul 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.
The absorption kinetics of dietary carnosine (β-alanyl-L-histidine) will be determined in the healthy adults.
Study design
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: pure carnosineCarnosine(450 mg) |
| 2 | Experimental | Other: BeefBeef (150g) |
| 3 | Experimental | Other: Chickenchicken (150g) |
| 4 | Experimental | Other: Chicken brothChicken broth (obtained from 150 g of chicken breast) |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy adult
- normal hematological parameters, normal serum albumin, normal liver function, normal kidney function
Key exclusion criteria (1 listed)
- History of smoking or alcoholism
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 |
|---|---|---|
| pure carnosineone time dose of pure carnosine (450 mg) | Dietary supplement | 1 |
| Beefone time dose, 150 g of beef | Other | 2 |
| ChickenOne time dose, 150g of chicken breast | Other | 3 |
| Chicken brothone time dose of chicken broth obtained from 150g of chicken breast | Other | 4 |
Primary outcome
Plasma histidine-dipeptide
Time frame: 0, 30, 60, 100, 180, 240, & 300 min
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 15 Dec 2009.
- Results publication: PubMed 19381778Yeum KJ, Orioli M, Regazzoni L, Carini M, Rasmussen H, Russell RM, Aldini G. Profiling histidine dipeptides in plasma and urine after ingesting beef, chicken or chicken broth in humans. Amino Acids. 2010 Mar;38(3):847-58. doi: 10.1007/s00726-009-0291-2. Epub 2009 Apr 19.
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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.
Kyung-Jin Yeum, Ph.D. principal investigator
Tufts Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pure carnosine, Beef and Chicken in people with Oxidative Stress, run by Tufts University 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 2 inclusion and 1 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 15 Dec 2009. 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. 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?
Plasma histidine-dipeptide (time frame: 0, 30, 60, 100, 180, 240, & 300 min). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00721708, which also lists 1 linked publication.
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 15 Dec 2009.