Effects of Almonds on Immune Health and Responsiveness

Study Overview
=================
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.

Official Title
-----------------
Effects of Almonds on Immune Health and Responsiveness

Conditions
-----------------
Diet Intervention

Intervention / Treatment
-----------------
* Other: Almond supplementation
* Other: Cookie supplementation


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond<br>Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks. | Other: Almond supplementation<br>* Daily consumption of 57g of whole almonds<br>|
| Active Comparator: Cookie<br>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<br>* Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.<br>|

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 |