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Clinical Trials/NCT05059639
NCT05059639CompletedNot Applicable

Exploring the Role of Almonds in Enhancing Immune Strength

San Diego State University1 site in 1 country48 target enrollmentStarted: November 15, 2021Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
48
Locations
1
Primary Endpoint
change in Natural Killer Function

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Other
Masking
None

Eligibility Criteria

Ages
40 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Pretzel

Active Comparator

Consume comparative amount of pretzel for 8 weeks

Intervention: Pretzel (Other)

Almond (2 ounces)

Experimental

Consume 2 ounces almond daily for 8 weeks

Intervention: Almond (Other)

Outcomes

Primary Outcomes

change in Natural Killer Function

Time Frame: 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 Outcomes

  • change in Cytokines(Baseline, after 8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mark Kern

Professor

San Diego State University

Study Sites (1)

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