Exploring the Role of Almonds in Enhancing Immune Strength

Not Applicable

Completed

• Conditions: Immune Health
• Interventions: Other: Almond; Other: Pretzel

• Registration Number: NCT05059639
• Lead Sponsor: San Diego State University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-09-27
• Study First Posted: 2021-09-28
• Study Start: 2021-11-15
• Primary Completion: 2023-11-15
• Study Completion: 2024-11-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Almond (2 ounces)	Almond	Consume 2 ounces almond daily for 8 weeks
Pretzel	Pretzel	Consume comparative amount of pretzel for 8 weeks

Primary Outcome Measures

Name	Time	Method
change in Natural Killer Function	Baseline, after 8 weeks	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mark Kern, PhD, RD; 🇺🇸 San Diego, California, United States