Effects of Almonds on Immune Health and Responsiveness

Not Applicable

Completed

• Conditions: Diet Intervention
• Interventions: Other: Almond supplementation; Other: Cookie supplementation

• Registration Number: NCT05530499
• Lead Sponsor: University of Missouri-Columbia

Brief Summary

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

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 Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-07
• Study Start: 2022-09-15
• Primary Completion: 2024-10-09
• Study Completion: 2024-10-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Almond	Almond supplementation	Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks.
Cookie	Cookie supplementation	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.

Primary Outcome Measures

Name	Time	Method
Change in immune and inflammatory markers	Over 6 weeks	Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.
Change in immune cell profile	Over 6 weeks	Immunophenotyping

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Missouri-Columbia; 🇺🇸 Columbia, Missouri, United States