Blueberry Supplementation for Immune Response Enhancement

(Blueberry Trial)

Overseen By Amandeep Kaur, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Loma Linda University

Must not be taking: Antibiotics, Corticoids, Immune supplements

Disqualifiers: Immune diseases, Uncontrolled chronic diseases, others

Compensation: Varies

Number of Visits: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether blueberry powder can boost the immune system and improve the response to the flu vaccine. It targets overweight older men and postmenopausal women who are not on medications or supplements affecting immunity and can receive a flu shot. Participants will take either a blueberry powder (a natural supplement) or a placebo (a non-active substitute) to observe differences in immune response. This study may suit those already considering a flu shot and open to trying a natural supplement approach. As an unphased trial, it offers participants the chance to contribute to innovative research on natural supplements and immune health.

Will I have to stop taking my current medications?

The trial requires that you are not taking any medications or supplements that affect immunity. If your current medications do affect immunity, you may need to stop taking them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that eating blueberries, whether fresh or as a powder, is generally safe. Studies have not found any serious side effects from blueberry supplements. Most participants in these studies tolerate blueberries well, with no major side effects reported.

For those considering a trial involving blueberry powder, these findings may offer reassurance. The research suggests that adding blueberry powder to your diet should not be harmful. However, always consult your doctor before making any decisions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for boosting immune response rely on pharmaceuticals or synthetic supplements. But this new approach uses freeze-dried blueberries, which are packed with natural antioxidants and phytonutrients. Researchers are excited about this because blueberries contain compounds like anthocyanins, which have been shown to support immune health in a natural way. Unlike synthetic supplements, this treatment is derived from a whole food source, offering a more holistic approach to enhancing immunity. Additionally, the convenience of a powder form makes it easy to incorporate into daily routines.

What evidence suggests that this trial's treatments could be effective for enhancing immune response?

Research shows that blueberries might help strengthen the immune system. An 8-week study using freeze-dried blueberry supplements found positive effects on the body's immune functions. Another study suggested that blueberries can improve immunity and gut health in babies, indicating their potential to boost immune response. Blueberry powder has also been linked to slight improvements in memory and daily activities for older adults. These findings suggest that blueberries could support the immune system, especially for older adults. Participants in this trial will receive either a blueberry powder or a placebo powder to evaluate its effects on immune response. ^{1 2 5 6 7}

Who Is on the Research Team?

Sujatha Rajaram, PhD

Principal Investigator

Loma Linda University

Joan Sabate, DrPH

Principal Investigator

Loma Linda University

Are You a Good Fit for This Trial?

This trial is for overweight older men and postmenopausal women aged 50-70 who agree to get a flu shot. They must have a BMI of 25-32, be able to travel to Loma Linda University, and not be on immune-affecting meds or supplements. Those regularly eating berries, on immune boosters, recently on antibiotics or steroids, allergic to blueberries, vaccinated for flu within the last 10 months, or with uncontrolled diseases can't join.

Inclusion Criteria

Able to commute to Loma Linda University

I am not on any immune-affecting drugs or supplements.

Agree to get vaccinated for Flu

Exclusion Criteria

I have recently taken antibiotics or steroids.

Regular intake of Blueberries and other berries (>2 ounces/week)

I am taking supplements to boost my immune system.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1 - Blueberry Consumption

Participants consume blueberries or placebo powder to examine effects on plasma markers of immune strength

8 weeks

Clinic visits at baseline and week 4

Phase 2 - Vaccination and Continued Consumption

Participants receive influenza vaccination and continue blueberry or placebo consumption to assess immune response

4 weeks

Clinic visit at week 8 before vaccination and week 4 after vaccination

Follow-up

Participants are monitored for changes in immune response and viral load after the intervention

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Blueberry powder group
• Placebo powder group

Trial Overview The study is testing if blueberry powder affects immunity and how well participants respond to the flu vaccine compared to a placebo group. Participants will receive either the blueberry powder or a placebo without knowing which one they are getting.

How Is the Trial Designed?

Group I: Blueberry powder group Experimental Treatment 2 Interventions

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

Group II: Placebo powder group Placebo Group 2 Interventions

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

Who Is Running the Clinical Trial?

Loma Linda University

Lead Sponsor

Trials

322

Recruited

267,000+

U.S. Highbush Blueberry Council

Collaborator

Trials

18

Recruited

1,100+

Published Research Related to This Trial

Wild blueberry powder retains a significant amount of its health-promoting anthocyanins in ice pops and refrigerated juice, with both products maintaining over 90% of their initial anthocyanin content after 8 weeks of storage.

The stability of polyphenolic compounds varies by product, with gummies showing much lower retention of anthocyanins (43-51%) compared to other formulations, likely due to gel hardening affecting extraction efficiency at lower temperatures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Polyphenolics during Storage of Products Prepared with Freeze-Dried Wild Blueberry Powder. Lavefve, L., Brownmiller, C., Howard, L., et al.[2020]

In a study involving 11 healthy subjects, a blend of botanicals (APR extract) significantly increased levels of immune-related chemokines and activated immune cells within hours of consumption, indicating enhanced immune surveillance.

The APR extract not only boosted immune cell alertness through activation markers but also improved antioxidant enzyme activity, suggesting it may provide protective benefits against oxidative stress while enhancing natural immune responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rapid increase in immune surveillance and expression of NKT and γδT cell activation markers after consuming a nutraceutical supplement containing Aloe vera gel, extracts of Poria cocos and rosemary. A randomized placebo-controlled cross-over trial. Yu, L., McGarry, S., Cruickshank, D., et al.[2023]

In a study involving 37 young adults, both whole blueberries and freeze-dried blueberry powder did not show significant differences in improving cardiovascular health compared to a control group, indicating that the form of blueberry may not matter for cardiovascular benefits.

However, both blueberry treatments improved plasma nitrite levels significantly compared to baseline, suggesting a potential positive effect on vascular function, even though other cardiovascular risk factors like blood pressure and cholesterol levels did not show significant changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. Wang, Y., Gallegos, JL., Haskell-Ramsay, C., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8130140/

An 8-week freeze-dried blueberry supplement impacts ... An 8-week freeze-dried blueberry supplement impacts immune-related pathways: a randomized, double-blind placebo-controlled trial - PMC.

2. news.cuanschutz.edu news.cuanschutz.edu/news-stories/blueberries-can-improve-infants-immunity-and-gut-health-cu-anschutz-study-finds

Blueberries Can Improve Infants' Immunity and Gut Health ... A new clinical trial shows early blueberry consumption may reduce allergy symptoms and support long-term health in babies. 2 minute read.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05534893?term=blueberry&viewType=Table&rank=8

Effect of Blueberries on Immunity and Response to Flu ... 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 ...

4. aaes.uada.edu aaes.uada.edu/news/research-aims-to-prove-childhood-health-benefits-of-blueberry-extracts/

Research Aims to Prove Childhood Health Benefits of ... Chen, director of ACNC's Bone Development Lab, showed that the polyphenols in Howard's blueberry powder improved bone health and growth in research animals.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7442370/

Recent Research on the Health Benefits of Blueberries and ... Blueberry powder intake led to modest benefits in memory performance and subjective improvements in everyday function among 39 older adults with cognitive ...

6. withpower.com withpower.com/trial/phase-inflammation-8-2022-f459b

Blueberry Supplementation for Immune Response ... Research indicates that consuming blueberries, whether fresh or in powder form, is generally safe for humans. Studies have not shown any significant adverse ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12430458/

Blueberry Consumption in Early Life and Its Effects on Allergy ... Conclusions: The consumptio9n of blueberries as an early complementary food may improve resolution of allergy symptoms, modulate immune ...