Effect of Blueberries on Immunity and Response to Flu Vaccination (Blueberry)
Primary Purpose
Immune Response, Inflammation
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blueberry powder group
Placebo powder group
Sponsored by
About this trial
This is an interventional prevention trial for Immune Response focused on measuring Almonds, Immunity, Inflammation
Eligibility Criteria
Inclusion Criteria:
- Older men and post-menopausal women aged 50-70 year 2. Have BMI of 25-32 3. Able to commute to Loma Linda University 3. Not taking medication or supplements that affect immunity 4. Agree to get vaccinated for Flu
Exclusion Criteria:
- Intolerance or allergy to Blueberries
- Regular intake of Blueberries and other berried (>2 ounces/week)
- Immune system insufficiency or disease
- Using immune boosting supplements
- Exposure to antibiotics and corticoids immediately prior to study
- Uncontrolled chronic diseases and relevant psychiatric illness, including major depression
- Flu vaccination less than 10 months ago from the start of the study
Sites / Locations
- Loma Linda University School of Public Health
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Blueberry powder group
Placebo powder group
Arm Description
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
Participants in the placebo group will receive an isocaloric placebo powder.
Outcomes
Primary Outcome Measures
changes in lymphocyte populations
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
changes in cytokine production
PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA
changes in natural killer (NK) cell activity
The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a
changes in serum inflammatory cytokine concentration
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
changes in complete blood count (CBC)
changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility
Secondary Outcome Measures
changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain
Neutralizing antibody titers in the serum against the hemagglutinin and neuraminidase of the vaccine strain will be measured using the standard commercial ELISA kits
changes in the viral load in response to vaccination
viral load in blood will be measured using a quantitative polymerase chain reaction
Full Information
NCT ID
NCT05534893
First Posted
September 6, 2022
Last Updated
July 6, 2023
Sponsor
Loma Linda University
Collaborators
U.S. Highbush Blueberry Council
1. Study Identification
Unique Protocol Identification Number
NCT05534893
Brief Title
Effect of Blueberries on Immunity and Response to Flu Vaccination
Acronym
Blueberry
Official Title
Immune Benefits of Blueberry Consumption and Response to Influenza Vaccination in Overweight Older Men and Postmenopausal Women: A Randomized Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 12, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
Collaborators
U.S. Highbush Blueberry Council
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight older men and postmenopausal women
Detailed Description
A free-living parallel, single-blind, RCT will be utilized. There will be two phases: Phase 1 - to examine the effects of Blueberries on plasma markers of immune strength, and Phase 2 - to assess the response to influenza vaccine following blueberry intake. Subjects will either consume their usual diet with (Blueberry group) or a placebo(control group) blueberries for 8 weeks, receive the influenza vaccination, and continue the intervention for another 4 weeks. The test food will be freeze-dried powder (FDP) (~ to 1 cup fresh blueberries) per day with the usual diet. The control will be the placebo powder with some guidelines to restrict all berries and other polyphenol-rich foods. The entire study will last 12 weeks. Participants will attend a baseline clinic at which time they will be randomized to one of the two groups. Clinic visits will occur at baseline, weeks 4 and 8 before, and week 4 after vaccination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response, Inflammation
Keywords
Almonds, Immunity, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
his will be a parallel, free-living, randomized controlled trial, where 52 overweight men and postmenopausal women will be randomized to receive either the freeze dried blueberries or a placebo powder
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm
Allocation
Randomized
Enrollment
52 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Blueberry powder group
Arm Type
Experimental
Arm Description
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
Arm Title
Placebo powder group
Arm Type
Placebo Comparator
Arm Description
Participants in the placebo group will receive an isocaloric placebo powder.
Intervention Type
Dietary Supplement
Intervention Name(s)
Blueberry powder group
Intervention Description
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo powder group
Intervention Description
Participants in the placebo powder group will receive an isocaloric placebo powder
Primary Outcome Measure Information:
Title
changes in lymphocyte populations
Description
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
Time Frame
baseline to 8 weeks
Title
changes in cytokine production
Description
PBMC cells will be separated from blood, activated and cultured using phytohemagglutinin (PHA). Inflammatory cytokine production will be measured in the resulting supernatant using ELISA
Time Frame
baseline to 8 weeks
Title
changes in natural killer (NK) cell activity
Description
The NK degranulation assay will be performed on blood samples. The test will be conducted using a modified flow cytometry method that measures the expression of CD107a
Time Frame
baseline to 8 weeks
Title
changes in serum inflammatory cytokine concentration
Description
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
Time Frame
baseline to 8 weeks
Title
changes in complete blood count (CBC)
Description
changes in the complete blood count will be performed on whole blood with the use of an automated hematology analyzer at a certified clinical facility
Time Frame
baseline to 8 weeks
Secondary Outcome Measure Information:
Title
changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain
Description
Neutralizing antibody titers in the serum against the hemagglutinin and neuraminidase of the vaccine strain will be measured using the standard commercial ELISA kits
Time Frame
week 8 to week 12
Title
changes in the viral load in response to vaccination
Description
viral load in blood will be measured using a quantitative polymerase chain reaction
Time Frame
week 8 to week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Older men and post-menopausal women aged 50-70 year 2. Have BMI of 25-32 3. Able to commute to Loma Linda University 3. Not taking medication or supplements that affect immunity 4. Agree to get vaccinated for Flu
Exclusion Criteria:
Intolerance or allergy to Blueberries
Regular intake of Blueberries and other berried (>2 ounces/week)
Immune system insufficiency or disease
Using immune boosting supplements
Exposure to antibiotics and corticoids immediately prior to study
Uncontrolled chronic diseases and relevant psychiatric illness, including major depression
Flu vaccination less than 10 months ago from the start of the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joan Sabate, DrPH
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sujatha Rajaram, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Loma Linda University School of Public Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Blueberries on Immunity and Response to Flu Vaccination
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