Effect of Blueberries on Immunity and Response to Flu Vaccination (Blueberry)

Loma Linda University (LLU)

Status: Active, not recruiting

Conditions: Immune Response; Inflammation

Treatments: Dietary Supplement: Blueberry powder group; Dietary Supplement: Placebo powder group

Study type: Interventional

Funder types: Other

Identifiers

NCT05534893

5220098

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 estimated patients

Sex: All

Ages: 50 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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52 participants in 2 patient groups, including a placebo group

Blueberry powder group

Experimental group

Description:

Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder

Treatment:

Dietary Supplement: Placebo powder group

Dietary Supplement: Blueberry powder group

Placebo powder group

Placebo Comparator group

Description:

Participants in the placebo group will receive an isocaloric placebo powder.

Treatment:

Dietary Supplement: Placebo powder group

Dietary Supplement: Blueberry powder group