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| Name | Class |
|---|---|
| Almond Board of California | OTHER |
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This study has the primary objective of investigating the benefits of consuming whole almonds on immune health and immune response in adults with obesity.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Almond | Experimental | Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks. |
|
| Cookie | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Almond supplementation | Other | Daily consumption of 57g of whole almonds |
| |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Gut microbiome profile | 16S rRNA sequencing | Baseline, week 6 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaapna Dhillon, PhD | University of Missouri-Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri-Columbia | Columbia | Missouri | 65211 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41830044 | Derived | Adepoju A, Rabbani E, Brickey P, Vieira-Potter V, Dhillon J. Almond Consumption Improves Inflammatory Profiles Independent of Weight Change: A 6-Week Randomized Controlled Trial in Adults with Obesity. Nutrients. 2026 Mar 9;18(5):875. doi: 10.3390/nu18050875. |
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Individual participant data that underlie the results reported here after deidentification (ie; text, tables, figures, and appendices)
Immediately following publication. No end date.
Data will be deposited in online repositories
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| Cookie supplementation |
| Other |
Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds. |
|
| 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 |