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| Name | Class |
|---|---|
| California Walnut Commission | OTHER |
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The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . To accomplish this objective, a human dietary intervention trial (RCT) with peanuts is proposed. The proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. This study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peanut group | Active Comparator | Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks |
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| control group | No Intervention | Participants will continue with habitual diet and abstain from eating peanuts |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peanut intake | Other | Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in lymphocyte populations | Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naive and memory cells and B cells | baseline to 12 weeks |
| Changes in Lymphocyte activity | The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA) | baseline to 12 weeks |
| Changes in cytokine production | The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA) | 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) will include hs-CRP, interleukin (IL)-1B, IL-6, TNF a, IL-10 and IFN-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3 | baseline to 12 weeks |
| Changes in the serum lipid concentration | This is a composite measurement which will measure the changes in the levels of serum low density cholesterol, high density cholesterol, non- high density cholesterol and triglycerides | baseline to 12 weeks |
| Changes in insulin resistance | Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR) | baseline to 12 weeks |
| Changes in Hemoglobin A1c |
| 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 12-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome. | baseline to 12 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 |
|---|---|
| D006331 | Heart Diseases |
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
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The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
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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.
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method |
| baseline to 12 weeks |
| Changes in body weight | A change in body weight for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention | baseline to 12 weeks |
| changes in systolic and diastolic blood pressure | Seated systolic and diastolic blood pressure will be measured at baseline and end of intervention utilizing Omron -Model HEM-7471 C device. Three measurements will be taken after a five-minute rest period, 1 minute apart, and the last two recordings will be averaged for analysis. | baseline to 12 weeks |
| changes in percentage body fat | A change in the percentage of body fat for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention | baseline to 12 weeks |