Nutritional DeficiencyNCT00950976
Dose-response Enteral Citrulline for Normal Healthy Volunteers and Surgery Patients
A study testing citrulline and Lemonade in people with Nutritional Deficiency, run by Société des Produits Nestlé (SPN) at 1 site in United States.
Trial summary
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Nutritional Deficiency
- What is being tested?
- citrulline and Lemonade
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Aug 2010
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults, male \& female, non-pregnant
- BMI 18.5-29.9
Who cannot join
- cancer
- HIV positive
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.
- Conditions
- Nutritional Deficiency
- Being tested
- citrulline, Lemonade
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
citrullineOther
TID for 5 days
LemonadeOther
TID for 5 days
| Study group | Role | What they receive |
|---|---|---|
| Citrulline | Experimental | Not described Receives: Other: citrulline |
| lemonade | Placebo comparator | Equal volume and flavor to citrulline. Receives: Other: Lemonade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma amino acid levels
Measured: 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2009 (estimated)
- Study startMar 2008
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutritional DeficiencyStudies 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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Société des Produits Nestlé (SPN)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Juan B. Ochoa, MD Prof., Principal investigator, Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00950976
- Sponsor's protocol ID
- ACSC-CIT-04-06-US
- Status last verified
- Apr 2012
- First submitted
- 10 Jul 2009
- 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
- Clinical Trial of Enteral Citrulline in Volunteers With Surgical Repair of Ventral Hernias
- ClinicalTrials.gov ID
- NCT00950976
- Acronym / sponsor ID
- ACSC-CIT-04-06-US
- Conditions
- Nutritional Deficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Société des Produits Nestlé (SPN)Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 3 Aug 2009 (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.
To determine the level of citrulline to produce a given amount of arginine in healthy volunteers and surgical patients. Arginine-related amino acids are expected to increase as a result of increased substrate provided by citrulline.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Citrulline | Experimental | Other: citrulline |
| lemonade | Placebo comparator | Other: LemonadeEqual volume and flavor to citrulline. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adults, male \& female, non-pregnant
- BMI 18.5-29.9
Key exclusion criteria (2 listed)
- cancer
- HIV positive
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 |
|---|---|---|
| citrullineTID for 5 days | Other | Citrulline |
| LemonadeTID for 5 days | Other | lemonade |
Primary outcome
Plasma amino acid levels
Time frame: 8 hours
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.
Juan B. Ochoa, MD Prof. principal investigator
Associate Professor of Surgery and Critical Care, University of Pittsburgh Physicians
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing citrulline and Lemonade in people with Nutritional Deficiency, run by Société des Produits Nestlé (SPN) 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 2 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 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?
Plasma amino acid levels (time frame: 8 hours). 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.