Exploring the Role of Almonds in Enhancing Immune Strength

Immune Health Clinical Trial

Official title:

Exploring the Role of Almonds in Enhancing Immune Strength

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05059639
• Other study ID #: 2021-06-18
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 15, 2021
• Est. completion date: November 15, 2024

Study information

• Verified date: December 2023
• Source: San Diego State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 48
• Est. completion date: November 15, 2024
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Immune Health

Intervention

Other:
• Almond
Consume 2 ounces of almond daily for 8 weeks
• Pretzel
Consume comparative amount of pretzel daily for 8 weeks

Locations

Country	Name	City	State
United States	Mark Kern, PhD, RD	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
San Diego State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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