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OpenTrials
Completed

NCT Number: NCT05059639

Exploring the Role of Almonds in Enhancing Immune Strength

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.

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Key information

Conditions

Immune Health

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mark Kern, PhD, RD

San Diego, California, 92182-7251, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Almond

Other

Consume 2 ounces of almond daily for 8 weeks

Pretzel

Other

Consume comparative amount of pretzel daily for 8 weeks

Primary outcomes

  1. 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

  1. change in Cytokines

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

San Diego State University

Other

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Sep 28, 2021
Registry last updated
Jan 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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