Exploring the Role of Almonds in Enhancing Immune Strength

Study Overview
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Brief Summary
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The COVID-19 pandemic highlights the importance of good nutritional status for immune strength and for reducing comorbidities that increase morbidity and mortality of infections. The major aim of this study is test if almond consumption can improve immune function.

Detailed Description
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Investigators will conduct an 8-week parallel-arm trial of 48 overweight/non-obese (BMI=24-30) adult (aged 40-65 years) men (n=24) and women (n=24) who will be randomly assigned to consume daily isoenergetic portions of almonds or a common snack (pretzels).

Official Title
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Exploring the Role of Almonds in Enhancing Immune Strength

Conditions
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Immune Health

Intervention / Treatment
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* Other: Almond
* Other: Pretzel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy male and female subjects aged 40-65 y Body mass index (BMI) 24-30 kg/m.2 Exclusion Criteria: Not willing to stop taking multivitamins, and supplements (with the exception of vitamin D and calcium), for 30 days prior to or during study participation, if currently taking these. Almond allergies Alcohol consumption >2 drinks per day. Smoking or using nicotine containing products in the last 6 months.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: forty-eight overweight/non-obese (BMI=24-30) adult (ages 40-65 years) men (n=24) and women (n=24) will be recruited to participate. A randomized, parallel-arm design will be utilized.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond (2 ounces)<br>Consume 2 ounces almond daily for 8 weeks | Other: Almond<br>* Consume 2 ounces of almond daily for 8 weeks<br>|
| Active Comparator: Pretzel<br>Consume comparative amount of pretzel for 8 weeks | Other: Pretzel<br>* Consume comparative amount of pretzel daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Natural Killer Function | The ability of peripheral blood mononuclear cells to bind and kill leukemia cells will be measured at baseline and at week-8 of the diet intervention using flowcytometry by assessing the concentration of natural killer cells. | Baseline, after 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in Cytokines | Peripheral blood will be analyzed at baseline and week-8 of diet intervention for cytokines including IL1, IL-6 and TNF alpha concentrations. | Baseline, after 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Almonds