HealthyNCT01713829
Cranberry Consumption Improves γδ T Cell Function
A study testing Cranberry Beverage in people with Healthy, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. Read more about this study
- Who is it for?
- Ages 21 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Cranberry Beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Aug 2013
- 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 21 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- between 21 and 35 years of age and in good health
- have a BMI between 18.5 and 29.9
- willing to consume the study beverage for 12 weeks
- willing to have a small amount of blood drawn two times
- willing to stop consuming tea and immune-enhancing dietary supplements (e.g. antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and Echinacea) before and during the 12 weeks of the study
- willing to consume no more than 7 servings of fruits and vegetables a day
- willing to limit your alcohol consumption to no more than 14 glasses a week
- willing to limit your yogurt consumption to no more than one 8oz. serving per day
Who cannot join
- have food allergies
- have hypertension
- taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or immunosuppressive drugs
- sensitive to aspirin or prone to kidney stones
- current smoker
- pregnant, lactating, or on hormone therapy, except for birth control pills
Trial locations and contacts
1 site in 1 country.
United States1 site
449 Food Science and Human Nutrition Department, University of Florida
Gainesville, Florida, 32611
About this study
The purpose of this study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. It is hypothesized that cranberry components will interact with immune cells to activate signaling pathways that enhance cell function. Enhanced immune cell function should result in reduced number, duration, and severity of cold and flu symptoms.
- Conditions
- Healthy
- Being tested
- Cranberry Beverage, Placebo Beverage
- Keywords
- cranberry, gamma delta T cell, improvement in immune cell function in healthy humans, proliferation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cranberry BeverageOther
8 oz cranberry beverage consumed daily for 12 weeks
Placebo BeverageOther
8 oz placebo beverage consumed daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cranberry Beverage | Experimental | Cranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks Receives: Other: Cranberry Beverage |
| Placebo Beverage | Placebo comparator | The placebo beverage looks like the active arm and is given in the same way but contains no active ingredient. Receives: Other: Placebo Beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Immune Cell Function
- Change in leukocyte phenotype
- Change in the ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo
- Change in peripheral blood mononuclear cell cytokine and chemokine production in response to mitogens
Measured: Measured at baseline and 6 weeks
Secondary outcomes (1)
Cold and Flu Symptoms
Incidence and severity of cold and flu symptoms, total and individual. Other signs of severity, for example, visits to doctor or health clinic, reduction in daily activities, prescribed or over-the-counter medications taken.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionJan 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- The Cranberry Institute
- Responsible party
- Sponsor
- Investigators
- Susan S Percival, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01713829
- Sponsor's protocol ID
- CB-472-2012
- Status last verified
- Jan 2014
- First submitted
- 18 Sep 2012
- Last updated
- 14 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Consumption Improves γδ T Cell Function
- ClinicalTrials.gov ID
- NCT01713829
- Acronym / sponsor ID
- CB-472-2012
- Conditions
- Healthy
- Keywords
- cranberry, gamma delta T cell, improvement in immune cell function in healthy humans, proliferation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- The Cranberry Institute
- Study start
- Oct 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 25 Oct 2012 (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 study is to determine the extent to which consuming a cranberry beverage modifies immune function, specifically related to γδ T cells and other innate immune cells. It is hypothesized that cranberry components will interact with immune cells to activate signaling pathways that enhance cell function. Enhanced immune cell function should result in reduced number, duration, and severity of cold and flu symptoms.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry Beverage | Experimental | Other: Cranberry BeverageCranberry Beverage is provided in an 8 oz daily beverage consumed once daily for 12 weeks |
| Placebo Beverage | Placebo comparator | Other: Placebo BeverageThe placebo beverage looks like the active arm and is given in the same way but contains no active ingredient. |
Who may qualify
- Ages
- 21 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- between 21 and 35 years of age and in good health
- have a BMI between 18.5 and 29.9
- willing to consume the study beverage for 12 weeks
- willing to have a small amount of blood drawn two times
- willing to stop consuming tea and immune-enhancing dietary supplements (e.g. antioxidant-, probiotic-, or flavonoid-containing supplements, fish oil, and Echinacea) before and during the 12 weeks of the study
Key exclusion criteria (6 listed)
- have food allergies
- have hypertension
- taking non-steroidal anti-inflammatory drugs on a chronic basis, antibiotics, or immunosuppressive drugs
- sensitive to aspirin or prone to kidney stones
- current smoker
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 Beverage8 oz cranberry beverage consumed daily for 12 weeks | Other | Cranberry Beverage |
| Placebo Beverage8 oz placebo beverage consumed daily for 12 weeks | Other | Placebo Beverage |
Primary outcome
Change in Immune Cell Function
Time frame: Measured at baseline and 6 weeks
* Change in leukocyte phenotype * Change in the ability of the natural killer and/or γδ T cells to proliferate when cultured ex vivo * Change in peripheral blood mononuclear cell cytokine and chemokine production in response to mitogens
1 secondary outcome
Cold and Flu Symptoms
Time frame: 12 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 14 Jan 2014.
Related trials for Healthy
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
Not yet recruiting
SUVY VerSus SAccharose (SUVISA)
Healthy Volunteers, Erythritol
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Not yet recruitingObservational study
Microneurographic Assessment of Peripheral Nerves in Healthy Volunteers and Individuals With Sensory Dysfunction Caused by Inherited Mutations in the PIEZO2 Gene
PIEZO2-Deficiency Syndrome
Enrolling by invitationObservational study
Connors Protocol for the Management and Use of Stored Human Specimens (Stored Human Specimens)
Healthy Volunteer Samples
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.
Susan S Percival, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cranberry Beverage in people with Healthy, run by University of Florida 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 8 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 14 Jan 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?
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?
Change in Immune Cell Function (time frame: Measured at baseline and 6 weeks). 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 14 Jan 2014.