Effects of Almonds on Immune Health and Responsiveness

NCT ID: NCT05530499

Last Updated: 2024-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2024-10-09

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Diet Intervention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Almond

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

Group Type EXPERIMENTAL

Almond supplementation

Intervention Type OTHER

Daily consumption of 57g of whole almonds

Cookie

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.

Group Type ACTIVE_COMPARATOR

Cookie supplementation

Intervention Type OTHER

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

Interventions

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Almond supplementation

Daily consumption of 57g of whole almonds

Intervention Type OTHER

Cookie supplementation

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

30 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Almond Board of California

OTHER

Sponsor Role collaborator

University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Jaapna Dhillon

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jaapna Dhillon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri-Columbia

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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2090290

Identifier Type: -

Identifier Source: org_study_id