Effects of Almonds on Immune Health and Responsiveness

This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.

Study Overview

• Status: Recruiting
• Conditions: Diet Intervention
• Intervention / Treatment: Other: Almond supplementation; Other: Cookie supplementation

Detailed Description

The study is a six week, randomized, controlled, and parallel arm clinical trial in which participants will be randomized to consume either 57 grams of whole almonds daily or to consume an isocaloric cookie snack daily. Outcomes assessed will include blood and adipose immune markers, cardiometabolic biomarkers, and gut microbiome.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jaapna Dhillon, PhD; Phone Number: 573-884-2103; Email: jdhillon@missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65211
      • Recruiting
      • University of Missouri-Columbia
      • Contact: Jaapna Dhillon, PhD; Phone Number: 573-884-2103; Email: jdhillon@missouri.edu
      • Contact: Rebecca Shafer, MS; Phone Number: 573-882-4517; Email: shaferrs@missouri.edu
      • Principal Investigator: Jaapna Dhillon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Body mass index (BMI): 30-45 kg/m^2
• Willingness to consume study foods
• Willing to comply with study protocol
• Consistent diet and activity patterns for 4 weeks
• Weight stable (no greater than 5 kg change over the last 3 months)
• Non-smoker > 1 year or more

Exclusion Criteria:

• Regular consumer of nuts
• Planning on getting viral vaccines during study
• Allergies to study foods (almonds, cookies)
• Illicit drug use
• Recent start of medications that affect metabolism or appetite
• Current use of medication that interfere with immune measures
• Diabetes
• Drug therapy for coronary artery disease, peripheral artery disease, congestive heart failure, or dyslipidemia
• Pregnant of lactating individuals
• Lidocaine allergies

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Almond; Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks.	Other: Almond supplementation; Daily consumption of 57g of whole almonds
Active Comparator: Cookie; Participants in this group will be instructed to consume cookies equivalent to the energy content of 57 grams of whole almonds every day for six weeks.	Other: Cookie supplementation; Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in immune and inflammatory markers	Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.	Over 6 weeks
Change in immune cell profile	Immunophenotyping	Over 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Measured in kg	Baseline, week 3, and week 6
Body composition	Fat mass and fat-free mass	Baseline, week 3, and week 6
Anthropometrics	Waist circumference, hip circumference, thigh circumference	Baseline, week 3, and week 6
Glucoregulation	Fasting glucose concentrations	Baseline and week 6
Insulinemic biomarker concentrations	Fasting insulin and C-peptide concentrations	Baseline and week 6
Lipid profile	LDL, HDL, triglycerides, total cholesterol	Baseline and week 6
Blood pressure	Diastolic and systolic blood pressure	Baseline, week 3, week 6
Dietary intake	24 hours dietary recall and food frequency questionnaires	Baseline, week 1, week 2, week 3, week 4, week 5, week 6
24 hour appetite ratings	24 hour appetite rating survey	Baseline, week 6
Physical activity	Activity assessment using Actigraphs	Baseline, week 6
Sleep	Sleep monitors and questionnaires	Baseline, week 6
Transcriptomics profiles	RNAseq	Baseline, week 6
Palatability rating of foods	Hedonic general labelled magnitude scale (gLMS)	Baseline, week 3, week 6
Acceptance rating of foods	9-point food action rating scale	Baseline, week 3, week 6

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gut microbiome profile	16S rRNA sequencing	Baseline, week 6

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Collaborators: Almond Board of California
• Investigators: Principal Investigator: Jaapna Dhillon, PhD, University of Missouri-Columbia

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): April 30, 2024

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): December 6, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2090290

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
• IPD Sharing Time Frame: Immediately following publication. No end date.
• IPD Sharing Access Criteria: Data will be deposited in online repositories
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No