BioavailabilityNCT00809900
Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry Consumption
An observational study of Bioavailability and Cardiovascular Disease, run by Tufts University at 1 site in United States.
Trial summary
This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Bioavailability, Cardiovascular Disease
- What is being tested?
- Experimental
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2007to Apr 2008
- Phase
- Observational
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease
Who may be able to join
- Stable CAD Patients
- Men \& postmenopausal women
- Aged 21-80 years
- All Ethnic Groups
- English Language
Who cannot join
- Subjects with heart failure are not eligible for participation in this study.
- Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
- Regular use of oral steroids
- Cigarette smoking and/or nicotine replacement use
- Regular daily intake of ≥ 2 alcoholic drinks
Show all 10Show fewer
- Illicit drug use
- History of a psychological illness or condition such as to interfere with the subject's ability to understand the requirements of the study.
- No dietary supplements containing phenolic compounds, i.e., herbal preparations, or berry containing preparations (such as cranberry capsules) for one month prior to study admission.
- Treatment with an investigational new drug within the last 30 days.
Trial locations and contacts
1 site in 1 country.
United States1 site
Jean Mayer USDA Human Nutrition Center on Aging at Tufts University
Boston, Massachusetts, 02111
About this study
Official title: Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry (Vaccinium Macrocarpon)Consumption
This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice.
Read the detailed description
Little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins consumed in amounts relevant to usual dietary intakes. Thus, we hypothesize that anthocyanins from a single oral dose of cranberry juice will be absorbed quickly and can be measured in the circulation and urine within 2-4 h. Further, these anthocyanins will undergo a degree of metabolism but will circulate as well as be removed from blood as both parent compounds and metabolic products.
This research proposal is submitted as an independent sub-study of an existing project, "Effects of Cranberry Juice on Endothelial Function in Patients with Coronary Artery Disease", conducted by Joseph A. Vita, MD at the Boston University School of Medicine and sponsored by Ocean Spray Cranberries, Inc.
This study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease who will receive a single dose of 480 mL cranberry juice.
To test the hypotheses of the study to be conducted at HNRCA Tufts, we will utilize blood and urine samples that are already collected and stored. We will separate and analyze anthocyanins in these samples by HPLC and determine the pharmacokinetics of relevant anthocyanins.
- Conditions
- Bioavailability, Cardiovascular Disease
- Being tested
- Experimental
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExperimentalDietary supplement
Also called Cranberry Juice
Administration of of 480 mL cranberry juice
| Study group | Role | What they receive |
|---|---|---|
| Dietary Supplement | Cranberry Juice Consumption Receives: Dietary Supplement: Experimental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthocyanin levels in plasma and urine
Measured: 0, 2, and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tufts University
- Sponsor type
- University, hospital or other
- Investigators
- Paul E. Milbury, Ph.D., Principal investigator, Tufts University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809900
- Sponsor's protocol ID
- Tufts 7903
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 2 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bioavailability and Metabolism of Anthocyanins Following Acute Cranberry (Vaccinium Macrocarpon)Consumption
- ClinicalTrials.gov ID
- NCT00809900
- Acronym / sponsor ID
- Tufts 7903
- Conditions
- Bioavailability, Cardiovascular Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Tufts UniversityUniversity, hospital or other
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 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.
This study hypothesis is that anthocyanins from cranberry juice are bioavailable and can be measured in blood and urine after a single acute consumption of cranberry juice.
Detailed description
Little is known about the acute or chronic pharmacokinetics and metabolism of anthocyanins consumed in amounts relevant to usual dietary intakes. Thus, we hypothesize that anthocyanins from a single oral dose of cranberry juice will be absorbed quickly and can be measured in the circulation and urine within 2-4 h. Further, these anthocyanins will undergo a degree of metabolism but will circulate as well as be removed from blood as both parent compounds and metabolic products.
This research proposal is submitted as an independent sub-study of an existing project, "Effects of Cranberry Juice on Endothelial Function in Patients with Coronary Artery Disease", conducted by Joseph A. Vita, MD at the Boston University School of Medicine and sponsored by Ocean Spray Cranberries, Inc.
This study includes 15 subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease who will receive a single dose of 480 mL cranberry juice.
To test the hypotheses of the study to be conducted at HNRCA Tufts, we will utilize blood and urine samples that are already collected and stored. We will separate and analyze anthocyanins in these samples by HPLC and determine the pharmacokinetics of relevant anthocyanins.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary Supplement | – | Dietary Supplement: ExperimentalCranberry Juice Consumption |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 21-80 y and with demonstrated endothelial dysfunction and angiographically proven coronary artery disease
Key inclusion criteria (5 listed)
- Stable CAD Patients
- Men \& postmenopausal women
- Aged 21-80 years
- All Ethnic Groups
- English Language
Key exclusion criteria (10 listed)
- Subjects with heart failure are not eligible for participation in this study.
- Women with a positive urine beta HCG pregnancy test and lactating women or women who are planning to become pregnant.
- Clinical history of other major illness including end-stage cancer, renal failure, hepatic failure, gastrointestinal disorders that may impair absorption, or other conditions that in the opinion of the principal investigator make a clinical study inappropriate.
- Regular use of oral steroids
- Cigarette smoking and/or nicotine replacement use
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 |
|---|---|---|
| ExperimentalAlso: Cranberry JuiceAdministration of of 480 mL cranberry juice | Dietary supplement | Dietary Supplement |
Primary outcome
Anthocyanin levels in plasma and urine
Time frame: 0, 2, and 4 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 2 Dec 2009.
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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.
Paul E. Milbury, Ph.D. principal investigator
Tufts University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bioavailability and Cardiovascular Disease, 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 5 inclusion and 10 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 2 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?
Anthocyanin levels in plasma and urine (time frame: 0, 2, and 4 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 2 Dec 2009.