InflammationNCT01780922
Effect of a Single Dose of Cranberry Beverage on Inflammation and Oxidative Stress
A study testing Low Calorie Cranberry Juice Cocktail, Cranberry Extract Beverage and Non-Cranberry Beverage in people with Inflammation, run by Washington State University at 1 site in United States.
Trial summary
The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Inflammation
- What is being tested?
- Low Calorie Cranberry Juice Cocktail, Cranberry Extract Beverage and Non-Cranberry Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men \& women; aged 18-35 years
- BMI: 19-25 kg/m2
Who cannot join
- Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
- Had major gastrointestinal surgery or on prescription or surgical treatment
- Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
- Regularly smoked in the previous 6 months
- On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
- Risk factors for AIDS or known HIV positive status
Show all 13Show fewer
- Pregnant or lactating
- High intake of chocolate or similar high polyphenol foods
- Regular intake of vitamin and polyphenol supplements
- Drug and alcohol misuse
- Currently participating or had participated in another clinical study during the previous 3 weeks
- Donated blood in the previous 3 weeks
- Exercise more than 3 times/week for longer than 45 min each time
Trial locations and contacts
1 site in 1 country.
United States1 site
WSU Bioactives Research Lab
Pullman, Washington, 99164
About this study
Official title: Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action
The purpose of this study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.
Read the detailed description
Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.
- Conditions
- Inflammation
- Being tested
- Low Calorie Cranberry Juice Cocktail, Cranberry Extract Beverage, Non-Cranberry Beverage
- Keywords
- Inflammation, Oxidative Stress, Vaccinium macrocarpon
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low Calorie Cranberry Juice CocktailOther
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
Cranberry Extract BeverageOther
Beverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes
Non-Cranberry BeverageOther
Beverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes
| Study group | Role | What they receive |
|---|---|---|
| Low Calorie Cranberry Juice Cocktail | Active comparator | Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes Receives: Other: Low Calorie Cranberry Juice Cocktail |
| Cranberry Extract Beverage | Active comparator | Beverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes Receives: Other: Cranberry Extract Beverage |
| Non-Cranberry Beverage | Placebo comparator | Beverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes Receives: Other: Non-Cranberry Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Measured: 0, 2, 4, 8, 24 h
Superoxide Dismutase (SOD) Activity in Red Blood Cells
Measured: 0, 2, 4, 8, 24 h
Glutathione Peroxidase (GPx) Activity in Red Blood Cells
Measured: 0, 2, 4, 8, 24 h
Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)
Measured: 0, 2, 4, 8, 24 h
C-Reactive Protein (CRP) Concentrations in Plamsa
Measured: 0, 2, 4, 8, 24 h
Nitric Oxide (NO) Concentrations in Plamsa
Measured: 0, 2, 4, 8, 24 h
Interleukin-1alpha (IL-1a) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-1beta (IL-1b) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-2 (IL-2) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-4 (IL-4) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-6 (IL-6) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-8 (IL-8) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interleukin-10 (IL-10) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Interferon-gamma (IFN-y) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
Measured: 0, 2, 4, 8, 24 h
Urinary Anti-bacteria Adhesion Activity
Measured: 0, 3, 6, 9, 12, 24 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2013 (estimated)
- Study startJul 2010
- Primary completionOct 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for InflammationStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Responsible party
- Sponsor
- Investigators
- Boon P Chew, PhD, Principal investigator, Washington State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01780922
- Sponsor's protocol ID
- 11369
- Status last verified
- Jun 2014
- First submitted
- 29 Jan 2013
- Last updated
- 8 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Bioavailability of Cranberry Polyphenols After A Single Dose In Healthy Adults and Its Antioxidative and Anti-Inflammatory Action
- ClinicalTrials.gov ID
- NCT01780922
- Acronym / sponsor ID
- 11369
- Conditions
- Inflammation
- Keywords
- Inflammation, Oxidative Stress, Vaccinium macrocarpon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Washington State UniversityUniversity, hospital or other
- Collaborators
- Ocean Spray Cranberries, Inc.
- Study start
- Jul 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 31 Jan 2013 (estimated)
- Results
- Posted 8 Jul 2014
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 study is to determine the effects of a single dose of cranberry beverage in healthy adults on the kinetic uptake of polyphenol compounds and polyphenol metabolites, and antioxidative and anti-inflammatory activity.
Detailed description
Participants will be randomized based on age, sex and BMI, and will consume a low-polyphenol diet 2 days prior to the intervention. On the day of the study, baseline blood and urine samples will be collected after an overnight fast. Participants will consume the assigned beverage within 15 minutes and blood collected at 2, 4, 8, and 24 h (10 mL/blood draw; total blood volume per period = 50 mL). Urine will be collected for polyphenol analysis during the following periods: 0-3, 3-6, 6-9, 9-12, 12-24 hours. After a one-week washout period, participants will receive their second and then the third beverage in a cross-over design; blood and urine sampling will be repeated at each of the 3 intervention periods.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Calorie Cranberry Juice Cocktail | Active comparator | Other: Low Calorie Cranberry Juice CocktailBeverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes |
| Cranberry Extract Beverage | Active comparator | Other: Cranberry Extract BeverageBeverage containing cranberry: one dose of 15.2 ounces consumed within 15 minutes |
| Non-Cranberry Beverage | Placebo comparator | Other: Non-Cranberry BeverageBeverage absent cranberry: one dose of 15.2 ounces consumed within 15 minutes |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Men \& women; aged 18-35 years
- BMI: 19-25 kg/m2
Key exclusion criteria (13 listed)
- Any significant chronic disease, hypertension, ulcers, dyspepsia, lactose intolerance, allergy, psychotic illness
- Had major gastrointestinal surgery or on prescription or surgical treatment
- Any condition that may interfere with the digestion, absorption, metabolism or excretion of nutrients
- Regularly smoked in the previous 6 months
- On medication or ingested a prescribed drug at any time within the 14 days preceding study enrolment (excluding hormonal contraceptives and hormone replacement therapy) or over-the-counter preparation within 7 days preceding enrolment
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 |
|---|---|---|
| Low Calorie Cranberry Juice CocktailBeverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes | Other | Low Calorie Cranberry Juice Cocktail |
| Cranberry Extract BeverageBeverage containing cranberry at a dose of 15.2 ounces consumed within 15 minutes | Other | Cranberry Extract Beverage |
| Non-Cranberry BeverageBeverage absent cranberry at a dose of 15.2 ounces consumed within 15 minutes | Other | Non-Cranberry Beverage |
Primary outcome
Reduced Glutathione (GSH) Concentrations in Red Blood Cells
Time frame: 0, 2, 4, 8, 24 h
Superoxide Dismutase (SOD) Activity in Red Blood Cells
Time frame: 0, 2, 4, 8, 24 h
Glutathione Peroxidase (GPx) Activity in Red Blood Cells
Time frame: 0, 2, 4, 8, 24 h
Oxidative Damage to DNA Assessed by Plasma 8-hydroxy-2'-Deoxyguanosine (8-OHdG)
Time frame: 0, 2, 4, 8, 24 h
C-Reactive Protein (CRP) Concentrations in Plamsa
Time frame: 0, 2, 4, 8, 24 h
Nitric Oxide (NO) Concentrations in Plamsa
Time frame: 0, 2, 4, 8, 24 h
Interleukin-1alpha (IL-1a) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-1beta (IL-1b) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-2 (IL-2) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-4 (IL-4) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-6 (IL-6) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-8 (IL-8) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interleukin-10 (IL-10) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Interferon-gamma (IFN-y) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Tumor Necrosis Factor-alpha (TNF-a) Concentrations in Plasma
Time frame: 0, 2, 4, 8, 24 h
Urinary Anti-bacteria Adhesion Activity
Time frame: 0, 3, 6, 9, 12, 24 h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Boon P Chew, PhD principal investigator
Washington State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low Calorie Cranberry Juice Cocktail, Cranberry Extract Beverage and Non-Cranberry Beverage in people with Inflammation, run by Washington State 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 13 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 8 Jul 2014. 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?
Yes. Results are posted in the registry (first posted 8 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Reduced Glutathione (GSH) Concentrations in Red Blood Cells (time frame: 0, 2, 4, 8, 24 h). The study lists 16 primary outcomes in all. 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 8 Jul 2014.