Effect of Blueberries on Immunity

NCT05534893 | Completed

• 1 other identifier: 5220098
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women

Conditions

Immune Response; Inflammation

Keywords

Blueberries; Immunity; Inflammation

Outcome Measures

Primary Outcomes (5)

• 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

  baseline to 12 weeks

• 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

  baseline to 12 weeks

• 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

  baseline to 12 weeks

• changes in serum inflammatory cytokine concentration

  Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)

  baseline to 12 weeks

• 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

  baseline to 12 weeks

Study Arms (2)

Blueberry powder group

EXPERIMENTAL

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

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

Placebo powder group

PLACEBO COMPARATOR

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

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

Interventions

Blueberry powder group DIETARY_SUPPLEMENT

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

Blueberry powder group; Placebo powder group

Placebo powder group DIETARY_SUPPLEMENT

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

Blueberry powder group; Placebo powder group

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older men and post-menopausal women aged 50-70 year
• Have BMI of 25-32
• Able to commute to Loma Linda University
• Consuming a typical American Diet low in polyphenols

You may not qualify if:

• 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 and or Covid Vaccination less than 3 months ago from the start of the study

Sponsors & Collaborators

• Loma Linda University: lead
• U.S. Highbush Blueberry Council: collaborator

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Joan Sabate, DrPH

  Loma Linda University

  PRINCIPAL INVESTIGATOR

• Sujatha Rajaram, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This 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

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 10, 2022
• Study Start: October 12, 2022
• Primary Completion: September 12, 2023
• Study Completion: September 12, 2023
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)