Healthy HumansNCT01398150
Cranberry Enhances Human Immune Function and Reduces Illness
A study testing Beverage made to look like the cranberry beverage and Beverage made from cranberry compounds in people with Healthy Humans, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Humans
- What is being tested?
- Beverage made to look like the cranberry beverage and Beverage made from cranberry compounds
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2009to May 2009
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Health male or non-pregnant female
- Between the ages of 21 and 50
- BMI between 18 and 35
Who cannot join
- High blood pressure define as 140/90
- Ongoing or chronic illness or infection
- On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
- Taking plant-based dietary supplements, antioxidant supplements, or probiotics
- Vegetarian or strict vegan
- Consume more than 1 cup of tea (iced or hot) per day
- Consumes more than 2 glasses of alcoholic beverages per day
- Consume more than 7 fruits and vegetables per day
Trial locations and contacts
1 site in 1 country.
United States1 site
449 Food Science and Human Nutrition Department
Gainesville, Florida, 32611
About this study
The purpose of this study is to determine whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.
Read the detailed description
The study will be conducted as a randomized, double blind, placebo-controlled parallel trial. Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the Placebo group and each will be instructed to consume the test beverages twice a day for 70 days. The beverage is not commercially prepared juice, but is a beverage prepared with an extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24 hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B and NK cell numbers and then cultured in autologous serum for 10 days to determine how well they proliferate. The supernatant of 24 hour cultures will be used for cytokine determination. If cells have been primed by the beverage made with cranberry compounds, the investigators expect the cells to proliferate to a greater extent and have modified cytokine production compared to placebo. If the beverage made with cranberry compounds enhances the proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the cranberry beverage. Incidence of illness is not expected to change, only the severity of the illness.
- Conditions
- Healthy Humans
- Being tested
- Beverage made to look like the cranberry beverage, Beverage made from cranberry compounds
- Keywords
- gamma delta T cell, proliferation, cytokine secretion, immune function, antioxidant status
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage made to look like the cranberry beverageDietary supplement
one 15 ounce bottle of beverage consumed daily
Beverage made from cranberry compoundsDietary supplement
one 15 ounce bottle consumed daily for 70 days
| Study group | Role | What they receive |
|---|---|---|
| Sweetened Beverage | Placebo comparator | looks like and is given in the same way as the experimental treatment but contains no active ingredient Receives: Dietary Supplement: Beverage made to look like the cranberry beverage |
| Cranberry Beverage | Experimental | 15 ounce bottle of cranberry beverage consumed daily for 70 days Receives: Dietary Supplement: Beverage made from cranberry compounds |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physiological modifications to immune cell function
Proliferation of γδ-T cells when cultured ex vivo in autologous serum
Measured: 70 days
Secondary outcomes (2)
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, medications prescribed or purchased OTC.
Measured: 70 days
Anti-inflammatory outcome
Serum antioxidant status, cytokine production and proliferation of αβ-T, B and NK cells
Measured: 70 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2011 (estimated)
- Study startMar 2009
- Primary completionMay 2009
- Study completionMay 2009
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 Healthy HumansStudies 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
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Responsible party
- Sponsor
- Investigators
- Susan S Percival, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01398150
- Sponsor's protocol ID
- CB-79545
- Status last verified
- Feb 2010
- First submitted
- 18 Jul 2011
- Last updated
- 20 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Nantz MP, Rowe CA, Muller C, Creasy R, Colee J, Khoo C, Percival SS. Consumption of cranberry polyphenols enhances human gammadelta-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study. Nutr J. 2013 Dec 13;12:161. doi: 10.1186/1475-2891-12-161.
PubMed 24330619
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cranberry Enhances Human Immune Function and Reduces Illness
- ClinicalTrials.gov ID
- NCT01398150
- Acronym / sponsor ID
- CB-79545
- Conditions
- Healthy Humans
- Keywords
- gamma delta T cell, proliferation, cytokine secretion, immune function, antioxidant status
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Study start
- Mar 2009
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 20 Jul 2011 (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 whether consuming a beverage made with cranberry polyphenols and proanthocyanidins is effective in modifying immune function by enhancing immune cell proliferation, cytokine production, and antioxidant capacity. If immune cell proliferation is improved, the subjects are expected to have fewer cold and flu symptoms.
Detailed description
The study will be conducted as a randomized, double blind, placebo-controlled parallel trial. Subjects will be randomly assigned to either the Treatment (cranberry beverage) group or the Placebo group and each will be instructed to consume the test beverages twice a day for 70 days. The beverage is not commercially prepared juice, but is a beverage prepared with an extract of cranberry that contains polyphenols and proanthocyanidins. Blood is taken at baseline, and day 70. Subjects are given a diary to keep a record of their cold and flu symptoms. Serum is used to determine the antioxidant activity by the ORAC method. Peripheral blood mononuclear cells are isolated from the blood draw and used fresh, cultured for 24 hours or cultured for 10 days. Freshly isolated cells will be used to determine αβ-T, γδ-T, B and NK cell numbers and then cultured in autologous serum for 10 days to determine how well they proliferate. The supernatant of 24 hour cultures will be used for cytokine determination. If cells have been primed by the beverage made with cranberry compounds, the investigators expect the cells to proliferate to a greater extent and have modified cytokine production compared to placebo. If the beverage made with cranberry compounds enhances the proliferation of one or more of these cell types (αβ-T, γδ T, B or NK cell), then it is possible that there will be fewer cold and flu symptoms in the group consuming the cranberry beverage. Incidence of illness is not expected to change, only the severity of the illness.
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 |
|---|---|---|
| Sweetened Beverage | Placebo comparator | Dietary Supplement: Beverage made to look like the cranberry beveragelooks like and is given in the same way as the experimental treatment but contains no active ingredient |
| Cranberry Beverage | Experimental | Dietary Supplement: Beverage made from cranberry compounds15 ounce bottle of cranberry beverage consumed daily for 70 days |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Health male or non-pregnant female
- Between the ages of 21 and 50
- BMI between 18 and 35
Key exclusion criteria (8 listed)
- High blood pressure define as 140/90
- Ongoing or chronic illness or infection
- On hypertensive medication, immunosuppressive drugs, antibiotics, or chronic use of NSAIDS
- Taking plant-based dietary supplements, antioxidant supplements, or probiotics
- Vegetarian or strict vegan
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 |
|---|---|---|
| Beverage made to look like the cranberry beverageone 15 ounce bottle of beverage consumed daily | Dietary supplement | Sweetened Beverage |
| Beverage made from cranberry compoundsone 15 ounce bottle consumed daily for 70 days | Dietary supplement | Cranberry Beverage |
Primary outcome
Physiological modifications to immune cell function
Time frame: 70 days
Proliferation of γδ-T cells when cultured ex vivo in autologous serum
2 secondary outcomes
Cold and flu symptoms
Time frame: 70 days
Anti-inflammatory outcome
Time frame: 70 days
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 20 Sep 2011.
- Derived from this study: PubMed 24330619Nantz MP, Rowe CA, Muller C, Creasy R, Colee J, Khoo C, Percival SS. Consumption of cranberry polyphenols enhances human gammadelta-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study. Nutr J. 2013 Dec 13;12:161. doi: 10.1186/1475-2891-12-161.
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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.
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 Beverage made to look like the cranberry beverage and Beverage made from cranberry compounds in people with Healthy Humans, 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 3 inclusion and 8 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 20 Sep 2011. 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?
Physiological modifications to immune cell function (time frame: 70 days). 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 NCT01398150, 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 20 Sep 2011.