Clinical trial NCT05534893: Effect of Blueberries on Immunity and Response to Flu Vaccination
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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Immune Response
Inflammation
Keywords: Almonds
Immunity
Inflammation
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: U.S. Highbush Blueberry Council
First posted: 2022-09-10
Enrollment: 52
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: PREVENTION

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.

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:

1. Intolerance or allergy to Blueberries
2. Regular intake of Blueberries and other berried (\>2 ounces/week)
3. Immune system insufficiency or disease
4. Using immune boosting supplements
5. Exposure to antibiotics and corticoids immediately prior to study
6. Uncontrolled chronic diseases and relevant psychiatric illness, including major depression
7. Flu vaccination less than 10 months ago from the start of the study

Primary outcomes:
measure: changes in lymphocyte populations
timeFrame: baseline to 8 weeks
measure: changes in cytokine production
timeFrame: baseline to 8 weeks
measure: changes in natural killer (NK) cell activity
timeFrame: baseline to 8 weeks
measure: changes in serum inflammatory cytokine concentration
timeFrame: baseline to 8 weeks
measure: changes in complete blood count (CBC)
timeFrame: baseline to 8 weeks
Secondary outcomes:
measure: changes in neutralizing antibody titers against hemagglutinin and neuraminidase of the vaccine strain
timeFrame: week 8 to week 12
measure: changes in the viral load in response to vaccination
timeFrame: week 8 to week 12
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
affiliation: Loma Linda University
name: Joan Sabate, DrPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Loma Linda University
name: Sujatha Rajaram, PhD
role: PRINCIPAL_INVESTIGATOR
References: