Immune ResponseBlueberryNCT05534893
Effect of Blueberries on Immunity
A study testing Blueberry powder group in people with Immune Response and Inflammation, run by Loma Linda University at 1 site in United States.
Trial summary
This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Inflammation
- What is being tested?
- Blueberry powder group
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 12 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Immune Benefits of Blueberry Consumption in Overweight Older Men and Postmenopausal Women: A Randomized Trial
This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women
Read the detailed description
This study will examine the effects of Blueberries on clinically relevant markers of immune function. Eligible and selected participants will be randomized to one of two groups at the baseline clinic visit. The Blueberry group participants will consume blueberries (2 packets of blueberry freeze-dried powder equivalent to 2 cups of fresh blueberries) added to the habitual diet and the Control group participants will abstain from blueberries (with instructions to limit the consumption of other berries and polyphenol rich foods) but otherwise continue their habitual diet. During the study, clinic visits will occur at 4-week intervals (baseline, weeks 4, 8 and 12) for a total of 4 visits at the Loma Linda University Nutrition Research Center. Blood samples taken at baseline and at week 12 will be assayed for changes in immune function and inflammatory markers.
- Conditions
- Immune Response, Inflammation
- Being tested
- Blueberry powder group, Placebo powder group
- Keywords
- Blueberries, Immunity, Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blueberry powder groupDietary supplement
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
Placebo powder groupDietary supplement
Participants in the placebo powder group will receive an isocaloric placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Blueberry powder group | Experimental | Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder Receives: 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. Receives: Dietary Supplement: Blueberry powder group; Dietary Supplement: Placebo powder group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start12 Oct 2022
- Primary completion12 Sep 2023
- Study completion12 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Responsible party
- Sponsor
- Investigators
- Joan Sabate, DrPH, Principal investigator, Loma Linda UniversitySujatha Rajaram, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05534893
- Sponsor's protocol ID
- 5220098
- Acronym
- Blueberry
- Status last verified
- Feb 2026
- First submitted
- 6 Sep 2022
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sanchez-Rosales AI, Rajaram S, Nemeh-Saad N, Sirirat R, Coats J, Cupino A, Unternaehrer JJ, Sabate J. Effect of blueberry consumption on regulatory lymphocyte phenotypes and NK cell functional activity in middle-aged and older adults with overweight or obesity: a randomized controlled trial. Front Immunol. 2026 Aug 26;17:1926790. doi: 10.3389/fimmu.2026.1926790. eCollection 2026.
PubMed 42719273
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immune Benefits of Blueberry Consumption in Overweight Older Men and Postmenopausal Women: A Randomized Trial
- ClinicalTrials.gov ID
- NCT05534893
- Acronym / sponsor ID
- Blueberry / 5220098
- Conditions
- Immune Response, Inflammation
- Keywords
- Blueberries, Immunity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- U.S. Highbush Blueberry Council
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 12 Sep 2023 (actual)
- Study completion
- 12 Sep 2023 (actual)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women
Detailed description
This study will examine the effects of Blueberries on clinically relevant markers of immune function. Eligible and selected participants will be randomized to one of two groups at the baseline clinic visit. The Blueberry group participants will consume blueberries (2 packets of blueberry freeze-dried powder equivalent to 2 cups of fresh blueberries) added to the habitual diet and the Control group participants will abstain from blueberries (with instructions to limit the consumption of other berries and polyphenol rich foods) but otherwise continue their habitual diet. During the study, clinic visits will occur at 4-week intervals (baseline, weeks 4, 8 and 12) for a total of 4 visits at the Loma Linda University Nutrition Research Center. Blood samples taken at baseline and at week 12 will be assayed for changes in immune function and inflammatory markers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Blueberry powder group | Experimental | Dietary Supplement: Blueberry powder group, Dietary Supplement: Placebo powder groupParticipants in the blueberry powder group will receive freeze dried blueberries in form of a powder |
| Placebo powder group | Placebo comparator | Dietary Supplement: Blueberry powder group, Dietary Supplement: Placebo powder groupParticipants in the placebo group will receive an isocaloric placebo powder. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blueberry powder groupParticipants in the blueberry powder group will receive freeze dried blueberries in form of a powder | Dietary supplement | Blueberry powder group, Placebo powder group |
| Placebo powder groupParticipants in the placebo powder group will receive an isocaloric placebo powder | Dietary supplement | Blueberry powder group, Placebo powder group |
Primary outcome
changes in lymphocyte populations
Time frame: baseline to 12 weeks
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
Time frame: baseline to 12 weeks
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
Time frame: baseline to 12 weeks
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
Time frame: baseline to 12 weeks
Changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA)
changes in complete blood count (CBC)
Time frame: baseline to 12 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 42719273Sanchez-Rosales AI, Rajaram S, Nemeh-Saad N, Sirirat R, Coats J, Cupino A, Unternaehrer JJ, Sabate J. Effect of blueberry consumption on regulatory lymphocyte phenotypes and NK cell functional activity in middle-aged and older adults with overweight or obesity: a randomized controlled trial. Front Immunol. 2026 Aug 26;17:1926790. doi: 10.3389/fimmu.2026.1926790. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joan Sabate, DrPH principal investigator
Loma Linda University
Sujatha Rajaram, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberry powder group in people with Immune Response and Inflammation, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in lymphocyte populations (time frame: baseline to 12 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05534893, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.