Exploring the Role of Almonds in Enhancing Immune Strength

NCT05059639 | Completed

• 1 other identifier: 2021-06-18
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Health

Keywords

Almonds

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• change in Cytokines

  Baseline, after 8 weeks

Study Arms (2)

Almond (2 ounces)

EXPERIMENTAL

Consume 2 ounces almond daily for 8 weeks

Other: Almond

Pretzel

ACTIVE COMPARATOR

Consume comparative amount of pretzel for 8 weeks

Other: Pretzel

Interventions

Almond OTHER

Consume 2 ounces of almond daily for 8 weeks

Almond (2 ounces)

Pretzel OTHER

Consume comparative amount of pretzel daily for 8 weeks

Pretzel

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male and female subjects aged 40-65 y
• Body mass index (BMI) 24-30 kg/m.2

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego State University: lead

Study Sites (1)

Mark Kern, PhD, RD

San Diego, California, 92182-7251, United States

Location

Study Officials

• Shirin Hooshmand, PhD, RD

  San Diego State University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: forty-eight overweight/non-obese (BMI=24-30) adult (ages 40-65 years) men (n=24) and women (n=24) will be recruited to participate. A randomized, parallel-arm design will be utilized.

Study Record Dates

• First Submitted: March 5, 2021
• First Posted: September 28, 2021
• Study Start: November 15, 2021
• Primary Completion: November 15, 2023
• Study Completion: November 15, 2024
• Last Updated: January 31, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)