52 Participants Needed

Blueberry Supplementation for Immune Response Enhancement

(Blueberry Trial)

JS
AK
Overseen ByAmandeep Kaur, MPH

Trial Summary

What is the purpose of this trial?

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

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.

What data supports the effectiveness of the treatment Blueberry powder for immune response enhancement?

Blueberries contain anthocyanins, which have antioxidant and anti-inflammatory properties that may help improve recovery and reduce fatigue. Additionally, flavonoids from blueberry leaves have shown potential in regulating immune responses in cell studies.12345

Is blueberry supplementation safe for humans?

Research indicates that consuming blueberries, whether fresh or in powder form, is generally safe for humans. Studies have not shown any significant adverse effects, and blueberries are widely recognized for their health benefits, including antioxidant and anti-inflammatory properties.678910

How does blueberry powder treatment enhance immune response compared to other treatments?

Blueberry powder is unique because it contains flavonoids and polyphenolic compounds that have antioxidant and anti-inflammatory properties, which may enhance immune response by reducing inflammation and oxidative stress. Unlike standard treatments, it uses natural ingredients and is consumed as a dietary supplement, making it a novel approach to boosting immunity.167911

Research Team

JS

Joan Sabate, DrPH

Principal Investigator

Loma Linda University

SR

Sujatha Rajaram, PhD

Principal Investigator

Loma Linda University

Eligibility Criteria

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
See 2 more

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.
See 4 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Blueberry powder groupExperimental Treatment2 Interventions
Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder
Group II: Placebo powder groupPlacebo Group2 Interventions
Participants in the placebo group will receive an isocaloric placebo powder.

Find a Clinic Near You

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+

Findings from Research

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

References

Immunomodulatory Effect of Flavonoids of Blueberry (Vaccinium corymbosum L.) Leaves via the NF-κB Signal Pathway in LPS-Stimulated RAW 264.7 Cells. [2022]
The berry health tool chest - an evidence map and interactive resource. [2022]
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. [2023]
Four Days of Blueberry Powder Supplementation Lowers the Blood Lactate Response to Running But Has No Effect on Time-Trial Performance. [2021]
Consumption of cranberry polyphenols enhances human γδ-T cell proliferation and reduces the number of symptoms associated with colds and influenza: a randomized, placebo-controlled intervention study. [2021]
Effects of Blueberry Consumption on Cardiovascular Health in Healthy Adults: A Cross-Over Randomised Controlled Trial. [2022]
Blueberry fruit valorization and valuable constituents: A review. [2022]
Changes in Polyphenolics during Storage of Products Prepared with Freeze-Dried Wild Blueberry Powder. [2020]
Recent Research on the Health Benefits of Blueberries and Their Anthocyanins. [2023]
Children's liking and wanting of foods vary over multiple bites/sips of consumption: A case study of foods containing wild blueberry powder in the amounts targeted to deliver bioactive phytonutrients for children. [2023]
The effects of blueberry and strawberry serum metabolites on age-related oxidative and inflammatory signaling in vitro. [2022]
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