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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05059639
Other study ID # 2021-06-18
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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