Cranberry Supplementation, Viral Defense, Antibody Response to the Flu Shot

NCT04597554 | Completed

• 1 other identifier: 20-0301
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Nutrition Immunology

Keywords

cranberry; influenza vaccination; antibody; viral defense

Outcome Measures

Primary Outcomes (1)

• Serum IgG and IgG1

  Serum concentrations for IgG and IgG1 for the 3 specific influenza vaccine strains

  Change from pre-study to 1 and 4 weeks post-flu shot (at the 4-week time point)

Secondary Outcomes (1)

• Anti-Viral Activity

  Change from pre-study to post-supplementation after 4, 5, and 8 weeks

Study Arms (2)

Cranberry

EXPERIMENTAL

4 oz. cranberry beverage (breakfast) and 2 chewable cranberry gummies (lunch) per day for 8 weeks.

Dietary Supplement: Cranberry

Placebo

PLACEBO COMPARATOR

4 oz. placebo beverage (breakfast) and 2 chewable placebo gummies (lunch) per day for 8 weeks.

Dietary Supplement: Placebo

Interventions

Cranberry DIETARY_SUPPLEMENT

Cranberry beverage and gummies supplement

Cranberry

Placebo DIETARY_SUPPLEMENT

Placebo beverages and gummies supplement

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Appalachian State University: lead
• Ocean Spray, Inc.: collaborator

Study Sites (1)

Appalachian State University Human Performance Lab, North Carolina Research Campus

Kannapolis, North Carolina, 28081, United States

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• David C Nieman

  Appalachian State Univ

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 16, 2020
• First Posted: October 22, 2020
• Study Start: September 21, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 31, 2021
• Last Updated: February 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)