Clinical trial NCT05530499: Effects of Almonds on Immune Health and Responsiveness
Official title: Effects of Almonds on Immune Health and Responsiveness
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Intervention
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
Collaborators: name: Almond Board of California
First posted: 2022-09-07
Enrollment: 90
Sex: ALL
Minimum age (years): 30
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in immune and inflammatory markers
timeFrame: Over 6 weeks
measure: Change in immune cell profile
timeFrame: Over 6 weeks
Secondary outcomes:
measure: Body mass
timeFrame: Baseline, week 3, and week 6
measure: Body composition
timeFrame: Baseline, week 3, and week 6
measure: Anthropometrics
timeFrame: Baseline, week 3, and week 6
measure: Glucoregulation
timeFrame: Baseline and week 6
measure: Insulinemic biomarker concentrations
timeFrame: Baseline and week 6
measure: Lipid profile
timeFrame: Baseline and week 6
measure: Blood pressure
timeFrame: Baseline, week 3, week 6
measure: Dietary intake
timeFrame: Baseline, week 1, week 2, week 3, week 4, week 5, week 6
measure: 24 hour appetite ratings
timeFrame: Baseline, week 6
measure: Physical activity
timeFrame: Baseline, week 6
measure: Sleep
timeFrame: Baseline, week 6
measure: Transcriptomics profiles
timeFrame: Baseline, week 6
measure: Palatability rating of foods
timeFrame: Baseline, week 3, week 6
measure: Acceptance rating of foods
timeFrame: Baseline, week 3, week 6
Other outcomes:
measure: Gut microbiome profile
timeFrame: Baseline, week 6
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Jaapna Dhillon, PhD
role: PRINCIPAL_INVESTIGATOR
References: