Effects of Almonds on Immune Health and Responsiveness

NCT05530499 | Completed DMC

• 1 other identifier: 2090290
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Diet Intervention

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (14)

• Body mass

  Baseline, week 3, and week 6

• Body composition

  Baseline, week 3, and week 6

• Anthropometrics

  Baseline, week 3, and week 6

• Glucoregulation

  Baseline and week 6

• Insulinemic biomarker concentrations

  Baseline and week 6

Other Outcomes (1)

• Gut microbiome profile

  Baseline, week 6

Study Arms (2)

Almond

EXPERIMENTAL

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

Other: Almond supplementation

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.

Other: Cookie supplementation

Interventions

Almond supplementation OTHER

Daily consumption of 57g of whole almonds

Almond

Cookie supplementation OTHER

Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.

Cookie

Eligibility Criteria

• Age: 30 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead
• Almond Board of California: collaborator

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65211, United States

Location

Study Officials

• Jaapna Dhillon, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 7, 2022
• Study Start: September 15, 2022
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Immediately following publication. No end date.
• Access Criteria: Data will be deposited in online repositories

Locations

US (1)