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This research study will test the effects of almonds on immune functions and immune response to influenza vaccine in overweight middle-aged men and postmenopausal women
The proposed study is a parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial on 66 overweight middle-aged men and post menopausal women. This study will be carried out in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of immune function, and Phase 2 will assess the antibody response to influenza vaccination following almond consumption. Participants will attend a baseline clinic and will be randomized to one of two groups. The Almond group will receive 15% of daily energy intake in the form of almonds as a snack and the Control group will continue thier usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week. The intervention will be for 12 weeks, at which time both group participants will receive the influenza vaccination, and continue the same dietary intervention for another 28 weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almonds | Experimental | The almond group will receive 15% of their daily energy intake in the form of almonds |
|
| Control | Placebo Comparator | The control group will be encouraged to continue their usual diet but completely avoid almonds and restrict other nuts to less than 2 servings per week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond group | Dietary Supplement | Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack |
|
| 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 lymphocyte activity and 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 |
| Measure | Description | Time Frame |
|---|---|---|
| changes in upper respiratory infection questionnaire score | Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire. The questionnaire will be completed daily by participants, either manually or electronically , throughout the 28-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome. | baseline to 28 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joan Sabate, DrPh | 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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this will be a parallel, free-living, randomized controlled trial, where 66 middle-aged men and post menopausal women will be randomized to receive either the almonds or control
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The investigator and outcome assessor will not be aware which participant is in what arm. The participant and the care provider will know about the treatment allocation
| Control Group | Dietary Supplement | The control group will continue their usual diet but will completely avoid almonds and restrict other nuts to less than 2 servings per week |
|
| changes in blood zinc levels | Zinc levels in blood will be analyzed in trace element- free tubes and assayed by atomic absorption spectrophotometry using standard reference material obtained from the National Institute of Standards and Technology to check the accuracy and precision of the determinations | baseline to 12 weeks |
| ID | Term |
|---|---|
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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