Nutrition ImmunologyNCT04597554
Cranberry Supplementation, Viral Defense, Antibody Response to the Flu Shot
A study testing Cranberry in people with Nutrition Immunology, run by Appalachian State University at 1 site in United States.
Trial summary
This study will investigate the effect of 8-weeks cranberry supplementation on the antibody response to influenza vaccination and ex-vivo anti-viral activity. The hypothesis is that 8-weeks ingestion of cranberry supplement relative to placebo will improve the antibody response to influenza vaccination and ex-vivo… Read more about this study
- Who is it for?
- Ages 40 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Nutrition Immunology
- What is being tested?
- Cranberry
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2020to 31 Dec 2021
- 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 40 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Able to provide written Informed Consent and follow verbal and written study directions in English.
- Adult men and women between ages 40-80 years.
- Body Mass Index (BMI) 25 to 40 kg/m2 (overweight, mild and moderate obesity).
- Must not be taking or be willing to stop taking cranberries or any products and supplements containing cranberries for seven days prior to the start of the study and for the duration of the study.
- Must not be taking or be willing to stop taking supplements containing probiotics, or polyphenols and flavonoids (e.g., quercetin, anthocyanins, green tea extract) for seven days prior to the start of the study and for the duration of the study.
- Able to maintain consistent diet and lifestyle habits throughout the study.
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- Healthy, noninstitutionalized participants or those with chronic but stable and well controlled medical conditions (i.e., hypertension controlled by a consistent dose of medication for a minimum of six months; chronic use of consistent dose of blood-thinning medication; diet-controlled Type II diabetes; statin controlled high blood cholesterol) may participate at the discretion of the primary investigator (PI).
- Willing and able to provide fasting blood samples and 24-hour urine samples.
- Able to attend four scheduled visits at the AppState Human Performance Laboratory at the North Carolina Research Campus facility in Kannapolis, NC.
- Willing to receive the 2020-21 seasonal influenza vaccination (with high-dose vaccinations given to those 65 years of age and older, as recommended by the Centers for Disease Control and Prevention).
Who cannot join
- Current active treatment for heart disease or cancer (excluding skin cancer), or medically complicated conditions (i.e., diabetes requiring insulin, uncontrolled high blood pressure), at the discretion of the primary investigator.
- Inability to provide a venous blood sample or 24-hour urine sample.
- Unable or unwilling to provide written informed consent for participation in study.
- History of allergic reactions to cranberry juice or products containing cranberries.
- Have already received the 2020-21 seasonal influenza vaccination.
Trial locations and contacts
1 site in 1 country.
United States1 site
Appalachian State University Human Performance Lab, North Carolina Research Campus
Kannapolis, North Carolina, 28081
About this study
Official title: Influence of 8-Weeks Cranberry Supplementation on the Antibody Response to Influenza Vaccination and Ex-Vivo Viral Defense
This study will investigate the effect of 8-weeks cranberry supplementation on the antibody response to influenza vaccination and ex-vivo anti-viral activity. The hypothesis is that 8-weeks ingestion of cranberry supplement relative to placebo will improve the antibody response to influenza vaccination and ex-vivo anti-viral defense.
Read the detailed description
Participants (n=90, ages 40-80 y) will be randomized to cranberry or placebo groups (with groups balanced for age, BMI, sex). Participants will provide blood and urine samples (lab visit #1), ingest cranberry or placebo supplements for 4-weeks, provide blood and urine samples and be vaccinated for influenza (lab visit #2), and provide two additional blood and urine samples after 1- (lab visit #3) and 4- additional weeks of supplementation (lab visit #4). Blood samples will be tested for seroconversion rates and haemagglutination inhibition [HI] titres, and anti-viral activity against viral infected Hela cells.
Lab Visit #1, Pre-Study: Orientation and review of the consent form (with next morning follow-up visit to turn in the 24-h urine sample). 10-15 minutes The informed consent form, Medical Health Questionnaire (MHQ), and 1-week retrospective symptom log (SYMPLOG) will be sent to the subject via email prior to Lab Visit #1. The research staff under the direction of the Research Manager will call each participant, review research procedures and the consent form, and set up appointment times for Lab Visit #1. Participants will be told that they will sign the consent form during Lab Visit #1. Participants will report to the NCRC Human Performance Lab in Kannapolis in an overnight fasted state (no food or beverages other the water for 8 or more hours). The study manager will make a final review of the consent form with the study participant prior to obtaining voluntary consent. Once voluntary consent has been provided by the study participant, the completed Medical Health Questionnaire (MHQ) and 1-week retrospective symptom log (SYMPLOG) will be turned in. The MHQ includes questions on lifestyle and medical histories. The SYMPLOG includes questions on digestive health (constipation, heartburn, bloating, diarrhea, and nausea), hunger levels (morning, afternoon, and evening), energy levels (morning, afternoon, and evening), sickness (fever, cough, sore throat, stuffy nose, runny nose, and headache), pain (joint, muscle, and back), allergies, stress level, focus/concentration, and overall well-being. Participants will indicate responses using a 12-point Likert scale with 1 relating to "none at all", 6 "moderate", and 12 "very high". Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position. Supplements for the first 4 weeks of the study will be provided. During visit #1, participants will be given a 3-day food record with thorough written and oral instructions on recording procedures (with food models). The 3-day food record will be completed on a Thursday, Friday, and Saturday sequence prior to visit #2. During visit #1, participants will be given two 24-h urine collection kits with thorough written and oral instruction on collection procedures. The first 24-h urine collection bottles will be collected during the 24-h period immediately after lab visit #1 and turned in the next morning. (To minimize contact, participants will stay in their cars and hand urine samples to a research staff member). Supplementation will start the day after lab visit #1. The second 24-h urine collection bottle will be collected during the 24-h period immediately prior to lab visit #2.
Lab Visit #2, 4-Week Time Point: Provide blood and urine samples and be vaccinated for influenza (10 to 15 min) Participants will report to the NCRC Human Performance Lab in Kannapolis after 4-weeks supplementation in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 3-day food record and the 24-h urine sample. Compliance to the supplementation regimen will be reviewed and subjects will be asked to return all unused supplements. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position.
Participants will receive the influenza vaccination for the 2020-21 season (in accordance with the CDC's Advisory Committee on Immunization Practices regarding the use of seasonal influenza vaccines in the United States). The influenza vaccination will not be administered by this study. The vaccinations will be provided by Walgreens personnel at the NCRC using standard procedures. Participants will receive the flu shot as clinically indicated by their physician or personnel administering the vaccine. The determination that the flu shot is not clinically indicated will also be determined by the participant's physician or personnel administering the vaccine. The high-dose vaccine will be used for study participants aged 65 years and older. (Note: Walgreens has provided influenza vaccinations at the NCRC for several years and have consented to provide them for our study participants. Participants will complete standard forms and present their insurance cards to cover the fee).
Supplements for the final 4 weeks of the study (weeks 5 through 8) will be provided. Participants will be given two 24-h urine collection bottles for Lab Visits #3 and #4.
Lab Visit #3, 5-Week Time Point: Provide blood and urine samples (10 min) Participants will report to the NCRC Human Performance Lab in Kannapolis at the 5-week time point in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 24-h urine sample. Compliance to the supplementation regimen will be reviewed and subjects will be asked to return all unused cranberry/placebo supplements. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Participants will remove their shoes and socks for the seca BIA measurement while holding the side rails. Blood samples will be taken from an antecubital vein with subjects in the seated position.
Lab Visit #4, 8-Week Time Point (end of study): Provide final blood and urine samples (10 min) Participants will report to the NCRC Human Performance Lab in Kannapolis at the 8-week time point in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 24-h urine sample. Compliance to the supplementation regimen will be reviewed. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position.
- Conditions
- Nutrition Immunology
- Being tested
- Cranberry, Placebo
- Keywords
- cranberry, influenza vaccination, antibody, viral defense
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CranberryDietary supplement
Cranberry beverage and gummies supplement
PlaceboDietary supplement
Placebo beverages and gummies supplement
| Study group | Role | What they receive |
|---|---|---|
| Cranberry | Experimental | 4 oz. cranberry beverage (breakfast) and 2 chewable cranberry gummies (lunch) per day for 8 weeks. Receives: Dietary Supplement: Cranberry |
| Placebo | Placebo comparator | 4 oz. placebo beverage (breakfast) and 2 chewable placebo gummies (lunch) per day for 8 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum IgG and IgG1
Serum concentrations for IgG and IgG1 for the 3 specific influenza vaccine strains
Measured: Change from pre-study to 1 and 4 weeks post-flu shot (at the 4-week time point)
Secondary outcomes (1)
Anti-Viral Activity
Serum antiviral activity and viral replication using the vesicular stomatitis virus
Measured: Change from pre-study to post-supplementation after 4, 5, and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start21 Sep 2020
- Primary completion30 Nov 2020
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nutrition ImmunologyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Appalachian State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Responsible party
- Sponsor
- Investigators
- David C Nieman, Principal investigator, Appalachian State Univ
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04597554
- Sponsor's protocol ID
- 20-0301
- Status last verified
- Feb 2022
- First submitted
- 16 Oct 2020
- Last updated
- 21 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon request; de-identified data
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of 8-Weeks Cranberry Supplementation on the Antibody Response to Influenza Vaccination and Ex-Vivo Viral Defense
- ClinicalTrials.gov ID
- NCT04597554
- Acronym / sponsor ID
- 20-0301
- Conditions
- Nutrition Immunology
- Keywords
- cranberry, influenza vaccination, antibody, viral defense
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Appalachian State UniversityUniversity, hospital or other
- Collaborators
- Ocean Spray, Inc.
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 30 Nov 2020 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 22 Oct 2020 (actual)
- 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 will investigate the effect of 8-weeks cranberry supplementation on the antibody response to influenza vaccination and ex-vivo anti-viral activity. The hypothesis is that 8-weeks ingestion of cranberry supplement relative to placebo will improve the antibody response to influenza vaccination and ex-vivo anti-viral defense.
Detailed description
Participants (n=90, ages 40-80 y) will be randomized to cranberry or placebo groups (with groups balanced for age, BMI, sex). Participants will provide blood and urine samples (lab visit #1), ingest cranberry or placebo supplements for 4-weeks, provide blood and urine samples and be vaccinated for influenza (lab visit #2), and provide two additional blood and urine samples after 1- (lab visit #3) and 4- additional weeks of supplementation (lab visit #4). Blood samples will be tested for seroconversion rates and haemagglutination inhibition [HI] titres, and anti-viral activity against viral infected Hela cells.
Lab Visit #1, Pre-Study: Orientation and review of the consent form (with next morning follow-up visit to turn in the 24-h urine sample). 10-15 minutes The informed consent form, Medical Health Questionnaire (MHQ), and 1-week retrospective symptom log (SYMPLOG) will be sent to the subject via email prior to Lab Visit #1. The research staff under the direction of the Research Manager will call each participant, review research procedures and the consent form, and set up appointment times for Lab Visit #1. Participants will be told that they will sign the consent form during Lab Visit #1. Participants will report to the NCRC Human Performance Lab in Kannapolis in an overnight fasted state (no food or beverages other the water for 8 or more hours). The study manager will make a final review of the consent form with the study participant prior to obtaining voluntary consent. Once voluntary consent has been provided by the study participant, the completed Medical Health Questionnaire (MHQ) and 1-week retrospective symptom log (SYMPLOG) will be turned in. The MHQ includes questions on lifestyle and medical histories. The SYMPLOG includes questions on digestive health (constipation, heartburn, bloating, diarrhea, and nausea), hunger levels (morning, afternoon, and evening), energy levels (morning, afternoon, and evening), sickness (fever, cough, sore throat, stuffy nose, runny nose, and headache), pain (joint, muscle, and back), allergies, stress level, focus/concentration, and overall well-being. Participants will indicate responses using a 12-point Likert scale with 1 relating to "none at all", 6 "moderate", and 12 "very high". Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position. Supplements for the first 4 weeks of the study will be provided. During visit #1, participants will be given a 3-day food record with thorough written and oral instructions on recording procedures (with food models). The 3-day food record will be completed on a Thursday, Friday, and Saturday sequence prior to visit #2. During visit #1, participants will be given two 24-h urine collection kits with thorough written and oral instruction on collection procedures. The first 24-h urine collection bottles will be collected during the 24-h period immediately after lab visit #1 and turned in the next morning. (To minimize contact, participants will stay in their cars and hand urine samples to a research staff member). Supplementation will start the day after lab visit #1. The second 24-h urine collection bottle will be collected during the 24-h period immediately prior to lab visit #2.
Lab Visit #2, 4-Week Time Point: Provide blood and urine samples and be vaccinated for influenza (10 to 15 min) Participants will report to the NCRC Human Performance Lab in Kannapolis after 4-weeks supplementation in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 3-day food record and the 24-h urine sample. Compliance to the supplementation regimen will be reviewed and subjects will be asked to return all unused supplements. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position.
Participants will receive the influenza vaccination for the 2020-21 season (in accordance with the CDC's Advisory Committee on Immunization Practices regarding the use of seasonal influenza vaccines in the United States). The influenza vaccination will not be administered by this study. The vaccinations will be provided by Walgreens personnel at the NCRC using standard procedures. Participants will receive the flu shot as clinically indicated by their physician or personnel administering the vaccine. The determination that the flu shot is not clinically indicated will also be determined by the participant's physician or personnel administering the vaccine. The high-dose vaccine will be used for study participants aged 65 years and older. (Note: Walgreens has provided influenza vaccinations at the NCRC for several years and have consented to provide them for our study participants. Participants will complete standard forms and present their insurance cards to cover the fee).
Supplements for the final 4 weeks of the study (weeks 5 through 8) will be provided. Participants will be given two 24-h urine collection bottles for Lab Visits #3 and #4.
Lab Visit #3, 5-Week Time Point: Provide blood and urine samples (10 min) Participants will report to the NCRC Human Performance Lab in Kannapolis at the 5-week time point in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 24-h urine sample. Compliance to the supplementation regimen will be reviewed and subjects will be asked to return all unused cranberry/placebo supplements. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Participants will remove their shoes and socks for the seca BIA measurement while holding the side rails. Blood samples will be taken from an antecubital vein with subjects in the seated position.
Lab Visit #4, 8-Week Time Point (end of study): Provide final blood and urine samples (10 min) Participants will report to the NCRC Human Performance Lab in Kannapolis at the 8-week time point in an overnight fasted state (no food or beverages other the water for 8 or more hours). Participants will turn in the 24-h urine sample. Compliance to the supplementation regimen will be reviewed. Participants will fill in the 1-week retrospective symptom log (SYMPLOG) before coming to the lab and turn in. Height, weight, and body composition will be obtained (in a screened off area of the lab to ensure privacy) using the seca Medical Body Composition Analyzer 514 bioelectrical impedance scale (Hanover, MD). Blood samples will be taken from an antecubital vein with subjects in the seated position.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cranberry | Experimental | Dietary Supplement: Cranberry4 oz. cranberry beverage (breakfast) and 2 chewable cranberry gummies (lunch) per day for 8 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo4 oz. placebo beverage (breakfast) and 2 chewable placebo gummies (lunch) per day for 8 weeks. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Able to provide written Informed Consent and follow verbal and written study directions in English.
- Adult men and women between ages 40-80 years.
- Body Mass Index (BMI) 25 to 40 kg/m2 (overweight, mild and moderate obesity).
- Must not be taking or be willing to stop taking cranberries or any products and supplements containing cranberries for seven days prior to the start of the study and for the duration of the study.
- Must not be taking or be willing to stop taking supplements containing probiotics, or polyphenols and flavonoids (e.g., quercetin, anthocyanins, green tea extract) for seven days prior to the start of the study and for the duration of the study.
Key exclusion criteria (5 listed)
- Current active treatment for heart disease or cancer (excluding skin cancer), or medically complicated conditions (i.e., diabetes requiring insulin, uncontrolled high blood pressure), at the discretion of the primary investigator.
- Inability to provide a venous blood sample or 24-hour urine sample.
- Unable or unwilling to provide written informed consent for participation in study.
- History of allergic reactions to cranberry juice or products containing cranberries.
- Have already received the 2020-21 seasonal influenza vaccination.
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 |
|---|---|---|
| CranberryCranberry beverage and gummies supplement | Dietary supplement | Cranberry |
| PlaceboPlacebo beverages and gummies supplement | Dietary supplement | Placebo |
Primary outcome
Serum IgG and IgG1
Time frame: Change from pre-study to 1 and 4 weeks post-flu shot (at the 4-week time point)
Serum concentrations for IgG and IgG1 for the 3 specific influenza vaccine strains
1 secondary outcome
Anti-Viral Activity
Time frame: Change from pre-study to post-supplementation after 4, 5, and 8 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 21 Feb 2022.
- Individual participant dataSharing planned: No. Upon request; de-identified data
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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.
David C Nieman principal investigator
Appalachian State Univ
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 in people with Nutrition Immunology, run by Appalachian 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 10 inclusion and 5 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 21 Feb 2022. 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?
Serum IgG and IgG1 (time frame: Change from pre-study to 1 and 4 weeks post-flu shot (at the 4-week time point)). 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 21 Feb 2022.