Effect of Blueberries on Immunity and Response to Flu Vaccination

NCT ID: NCT05534893

Last Updated: 2025-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-12

Study Completion Date

2025-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Response Inflammation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Blueberry powder group

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

Group Type EXPERIMENTAL

Blueberry powder group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo powder group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo powder group

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

Group Type PLACEBO_COMPARATOR

Blueberry powder group

Intervention Type DIETARY_SUPPLEMENT

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

Placebo powder group

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Blueberry powder group

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

Intervention Type DIETARY_SUPPLEMENT

Placebo powder group

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

U.S. Highbush Blueberry Council

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Joan Sabate, DrPH

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Sujatha Rajaram, PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University School of Public Health

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5220098

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effects of BCG on Influenza Induced Immune Response
NCT02114255 COMPLETED PHASE2/PHASE3