Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04597554 |
| Other study ID # |
20-0301 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
September 21, 2020 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
February 2022 |
| Source |
Appalachian State University |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 anti-viral defense.
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.
