Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597554
Status:
COMPLETED
Last Update Posted:
2022-02-21
First Post:
2020-10-16
Brief Title:
Cranberry Supplementation Viral Defense Antibody Response to the Flu Shot
Sponsor:
Appalachian State University
Organization:
Appalachian State University
Study Overview
Official Title:
Influence of 8-Weeks Cranberry Supplementation on the Antibody Response to Influenza Vaccination and Ex-Vivo Viral Defense
Status:
COMPLETED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 anti-viral defense
Detailed Description:
Participants n90 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 focusconcentration 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 CDCs 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 participants 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 cranberryplacebo 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
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 focusconcentration 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 CDCs 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 participants 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 cranberryplacebo 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None