Urinary Tract InfectionsPhase 1CUPACSNCT02087735
Measurement of Urinary Catabolites of PACs as Biomarkers of Consumption of Cranberry Extracts
A Phase 1 study testing Cranberry extract in people with Urinary Tract Infections, run by Laval University at 1 site in Canada.
Trial summary
The purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Urinary Tract Infections
- What is being tested?
- Cranberry extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Mar 2014
- Phase
- Phase 1
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy women.
- 18 to 40 years.
Who cannot join
- No internet access.
- No refrigerator access during the 9 hours of sample collection.
- Women who had or expect to take antibiotic.
- Women who had or expect to take cranberries, blueberries or bilberries in the form of berries, juice or extracts.
- Women who had or expect to take dark chocolate.
- Women who had personal history of acute or chronic renal failure.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Laval University, Department of Medecine, Institut sur la nutrition et les aliments fonctionnels (INAF).
Québec, Quebec, G1V 0A6
About this study
Official title: Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.
The purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.
- Conditions
- Urinary Tract Infections
- Being tested
- Cranberry extract
- Keywords
- Cranberry, Proanthocyanidins, Urinary catabolites
- Medical subject headings
- Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry extractDietary supplement
The aim of this pilot study is to evaluate the urinary catabolites of PACs as a biomarker of consumption of cranberry extracts within 9 hours of intercourse. Once a week, for 3 weeks, the women will receive a sequence of 3 different cranberry extracts (72 mg, 36 mg and 2mg (placebo)). The participant will have to collect its urine for a period of 9 hours in 3 different containers (one different container for 3 hours).
| Study group | Role | What they receive |
|---|---|---|
| cranberry extract 1 | Experimental | One capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract. Receives: Dietary Supplement: Cranberry extract |
| cranberry extract 2. | Experimental | Two capsules with a proanthocyanidin standardized cranberry extract of 36 mg. Receives: Dietary Supplement: Cranberry extract |
| cranberry extract 3. | Placebo comparator | Two capsules with a proanthocyanidin standardized cranberry extract of 2 mg. Receives: Dietary Supplement: Cranberry extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urinary catabolites of PACs
Measured: within 9 hours following the intake of cranberry extracts
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2014
- Study completionMar 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionsStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sylvie Dodin, Laval University
- Investigators
- Sylvie Dodin, MD, Principal investigator, Laval University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02087735
- Sponsor's protocol ID
- PACS-2013-SD
- Acronym
- CUPACS
- Status last verified
- Oct 2016
- First submitted
- 12 Mar 2014
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Urinary Catabolites of the Proanthocyanidines (PACs) in Healthy Young Women as Biomarkers of Consumption of Cranberry Extracts.
- ClinicalTrials.gov ID
- NCT02087735
- Acronym / sponsor ID
- CUPACS / PACS-2013-SD
- Conditions
- Urinary Tract Infections
- Keywords
- Cranberry, Proanthocyanidins, Urinary catabolites
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2014 (actual)
- First posted
- 14 Mar 2014 (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 purpose of this cross over pilot study is to investigate the urinary catabolites of Proanthocyanidines (PACs) as biomarkers of cranberry extracts in healthy young women.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cranberry extract 1 | Experimental | Dietary Supplement: Cranberry extractOne capsule with a proanthocyanidin standardized cranberry extract of 36 mg and one capsule of placebo cranberry extract. |
| cranberry extract 2. | Experimental | Dietary Supplement: Cranberry extractTwo capsules with a proanthocyanidin standardized cranberry extract of 36 mg. |
| cranberry extract 3. | Placebo comparator | Dietary Supplement: Cranberry extractTwo capsules with a proanthocyanidin standardized cranberry extract of 2 mg. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy women.
- 18 to 40 years.
Key exclusion criteria (6 listed)
- No internet access.
- No refrigerator access during the 9 hours of sample collection.
- Women who had or expect to take antibiotic.
- Women who had or expect to take cranberries, blueberries or bilberries in the form of berries, juice or extracts.
- Women who had or expect to take dark chocolate.
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 |
|---|---|---|
| Cranberry extractThe aim of this pilot study is to evaluate the urinary catabolites of PACs as a biomarker of consumption of cranberry extracts within 9 hours of intercourse. Once a week, for 3 weeks, the women will receive a sequence of 3 different cranberry extracts (72 mg, 36 mg and 2mg (placebo)). The participant will have to collect its urine for a period of 9 hours in 3 different containers (one different container for 3 hours). | Dietary supplement | cranberry extract 1, cranberry extract 2., cranberry extract 3. |
Primary outcome
Urinary catabolites of PACs
Time frame: within 9 hours following the intake of cranberry extracts
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 10 Oct 2016.
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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.
Sylvie Dodin, MD principal investigator
Laval University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Cranberry extract in people with Urinary Tract Infections, run by Laval University at 1 site in Canada.
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 6 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 10 Oct 2016. 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 Canada. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Urinary catabolites of PACs (time frame: within 9 hours following the intake of cranberry extracts). 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 10 Oct 2016.