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| Name | Class |
|---|---|
| U.S. Highbush Blueberry Council | OTHER |
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This research study will test the effects of Blueberries on immune functions in overweight older men and postmenopausal women
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blueberry powder group | Experimental | Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder |
|
| Placebo powder group | Placebo Comparator | Participants in the placebo group will receive an isocaloric placebo powder. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blueberry powder group | Dietary Supplement | Participants in the blueberry powder group will receive freeze dried blueberries in form of a powder |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Sabate, DrPH | Loma Linda University | Principal Investigator |
| Sujatha Rajaram, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University School of Public Health | Loma Linda | California | 92350 | United States |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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
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The investigator, participant, care provider, outcomes assessor will not be aware of which participant is in which arm
| Placebo powder group | Dietary Supplement | Participants in the placebo powder group will receive an isocaloric placebo powder |
|