Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

Study Overview
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Brief Summary
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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.

Detailed Description
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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 . 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.

Official Title
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Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial

Conditions
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Immune Response, Cardiometabolic Risk Factors

Intervention / Treatment
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* Other: Peanut intake


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adults between the ages of 18-70 years Exclusion Criteria: known intolerance or allergy to peanuts bad dentures unable to chew peanuts regular intake of peanuts and/or other nuts (>3 ounces/week) use of immune-boosting supplements exposure to antibiotics and corticoids immediately prior to the study use of other medications or supplements that can interfere with the immune functions Individuals that received any vaccination (i.e flu or Covid 19) 6 months prior to the start of the study

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Peanut group<br>Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks | Other: Peanut intake<br>* Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks<br>|
| No Intervention: control group<br>Participants will continue with habitual diet and abstain from eating peanuts | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Peanuts, Immunity, heart disease