Effects of Almonds on Immune Health and Responsiveness

University of Missouri (MU)

Status: Completed

Conditions: Diet Intervention

Treatments: Other: Almond supplementation; Other: Cookie supplementation

Study type: Interventional

Funder types: Other

Identifiers

NCT05530499

2090290

Details and patient eligibility

About

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

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 30 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

90 participants in 2 patient groups

Almond

Experimental group

Description:

Participants in this group will be instructed to consume 57 grams of whole almonds every day for six weeks.

Treatment:

Other: Almond supplementation

Cookie

Active Comparator group

Description:

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.

Treatment:

Other: Cookie supplementation