BioavailabilityNCT01789359
Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
A study testing Blueberry Juice in people with Bioavailability, run by Atlantic Food and Horticulture Research Center at 1 site in Canada.
Trial summary
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Bioavailability
- What is being tested?
- Blueberry Juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Dec 2012
- 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 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provided written consent (see: Information and Consent Form)
- Fluent in English
- Complete a confidential medical questionnaire (Appendix 6)
- Able and willing to abide by the dietary restrictions as described
- Able and willing to abide by the urine collection protocols as described
Who cannot join
- No written consent
- No confidential medical questionnaire
- Unable to comply with diet restrictions and other study requirements
Trial locations and contacts
1 site in 1 country.
Canada1 site
Atlantic Food & Horticulture Research Centre
Kentville, Nova Scotia, B4N 1J5
About this study
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.
- Conditions
- Bioavailability
- Being tested
- Blueberry Juice
- Keywords
- anthocyanin, bioavailability, urine, long-term
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry JuiceOther
Also called Single strength wild blueberry juice, commercially prepared.
Dietary intervention
| Study group | Role | What they receive |
|---|---|---|
| anthocyanin-free diet | Other | Maintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose. Receives: Other: Blueberry Juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthocyanins and Phase 2 anthocyanin conjugates in urine
Measured: 5 weeks
Secondary outcomes (1)
White blood cell gene expression at start and end of study
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startNov 2012
- Primary completionDec 2012
- Study completionDec 2012
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 BioavailabilityStudies 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
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Atlantic Food and Horticulture Research Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wilhelmina - Kalt, Ph.D., Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789359
- Sponsor's protocol ID
- BBAnthoUrine
- Other IDs
- AAFC-WBANA
- Status last verified
- Oct 2012
- First submitted
- 8 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Kalt W, Liu Y, McDonald JE, Vinqvist-Tymchuk MR, Fillmore SA. Anthocyanin metabolites are abundant and persistent in human urine. J Agric Food Chem. 2014 May 7;62(18):3926-34. doi: 10.1021/jf500107j. Epub 2014 Jan 27.
PubMed 24432743
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary Excretion of Anthocyanins During Long Term Blueberry Feeding
- ClinicalTrials.gov ID
- NCT01789359
- Acronym / sponsor ID
- BBAnthoUrine
- Conditions
- Bioavailability
- Keywords
- anthocyanin, bioavailability, urine, long-term
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Atlantic Food and Horticulture Research CenterOther government
- Study start
- Nov 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 12 Feb 2013 (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.
Essentially all of the published data on anthocyanin absorption in humans are from short term studies - a few days or less, most typically 24 h. However human studies demonstrating clinical effects are typically conducted for several weeks or even months. To examine how anthocyanin absorption and metabolism may be affected this study will examine urinary excretion of anthocyanins over one month, followed by a one week washout, and then one more dose of blueberry juice.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anthocyanin-free diet | Other | Other: Blueberry JuiceMaintain anthocyanin-free diet throughout study. Day 1 to day 30, consume daily 250 ml single strength blueberry juice containing 229 mg anthocyanins, taken either as 1 morning dose or 1/3 dose morning, 1/3 mid-day and 1/3 evening. At d 31-38 continue anthocyanin-free diet. On d 39 consume daily dose. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Provided written consent (see: Information and Consent Form)
- Fluent in English
- Complete a confidential medical questionnaire (Appendix 6)
- Able and willing to abide by the dietary restrictions as described
- Able and willing to abide by the urine collection protocols as described
Key exclusion criteria (3 listed)
- No written consent
- No confidential medical questionnaire
- Unable to comply with diet restrictions and other study requirements
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 |
|---|---|---|
| Blueberry JuiceAlso: Single strength wild blueberry juice, commercially prepared.Dietary intervention | Other | anthocyanin-free diet |
Primary outcome
Anthocyanins and Phase 2 anthocyanin conjugates in urine
Time frame: 5 weeks
1 secondary outcome
White blood cell gene expression at start and end of study
Time frame: 4 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 12 Feb 2013.
- Derived from this study: PubMed 24432743Kalt W, Liu Y, McDonald JE, Vinqvist-Tymchuk MR, Fillmore SA. Anthocyanin metabolites are abundant and persistent in human urine. J Agric Food Chem. 2014 May 7;62(18):3926-34. doi: 10.1021/jf500107j. Epub 2014 Jan 27.
Related trials for Bioavailability
Not yet recruitingPhase 1
Comparing the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations After Multiple Doses
Obesity, Overweight
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruitingPhase 1
A Comparative Study to Investigate the Difference in Blood Levels of Two Different Formulations of GSK5784283
Asthma
Not yet recruitingPhase 1
A Study of Imlunestrant (LY3484356) in Healthy Female Participants
Healthy
Active, not recruitingPhase 4
Tacrolimus C:D Ratio Measured in Renal Transplant Recipients Treated With Once-daily Prolonged-release Drugs
Immunosuppression
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.
Wilhelmina - Kalt, Ph.D. principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry Juice in people with Bioavailability, run by Atlantic Food and Horticulture Research Center 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 5 inclusion and 3 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 12 Feb 2013. 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. 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?
Anthocyanins and Phase 2 anthocyanin conjugates in urine (time frame: 5 weeks). 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 NCT01789359, 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 12 Feb 2013.