Diet Intervention
Conditions
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.
Interventions
OTHERAlmond supplementation
Daily consumption of 57g of whole almonds
OTHERCookie supplementation
Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.
Sponsors
Almond Board of California
University of Missouri-Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
30 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in immune cell profile | Over 6 weeks | Immunophenotyping |
| Change in immune and inflammatory markers | Over 6 weeks | Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | Baseline, week 3, and week 6 | Fat mass and fat-free mass |
| Anthropometrics | Baseline, week 3, and week 6 | Waist circumference, hip circumference, thigh circumference |
| Glucoregulation | Baseline and week 6 | Fasting glucose concentrations |
| Insulinemic biomarker concentrations | Baseline and week 6 | Fasting insulin and C-peptide concentrations |
| Lipid profile | Baseline and week 6 | LDL, HDL, triglycerides, total cholesterol |
| Blood pressure | Baseline, week 3, week 6 | Diastolic and systolic blood pressure |
| 24 hour appetite ratings | Baseline, week 6 | 24 hour appetite rating survey |
| Physical activity | Baseline, week 6 | Activity assessment using Actigraphs |
| Sleep | Baseline, week 6 | Sleep monitors and questionnaires |
| Transcriptomics profiles | Baseline, week 6 | RNAseq |
| Palatability rating of foods | Baseline, week 3, week 6 | Hedonic general labelled magnitude scale (gLMS) |
| Acceptance rating of foods | Baseline, week 3, week 6 | 9-point food action rating scale |
| Dietary intake | Baseline, week 1, week 2, week 3, week 4, week 5, week 6 | 24 hours dietary recall and food frequency questionnaires |
| Body mass | Baseline, week 3, and week 6 | Measured in kg |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gut microbiome profile | Baseline, week 6 | 16S rRNA sequencing |
Countries
United States
Outcome results
None listed