Effects of Almonds on Immune Health and Responsiveness

Diet Intervention Clinical Trial

Official title:

Effects of Almonds on Immune Health and Responsiveness

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530499
• Other study ID #: 2090290
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: April 30, 2024

Study information

• Verified date: December 2023
• Source: University of Missouri-Columbia
• Contact: Jaapna Dhillon, PhD
• Phone: 573-884-2103
• Email: jdhillon[@]missouri.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 30 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diet Intervention

Intervention

Other:
• Almond supplementation
Daily consumption of 57g of whole almonds
• Cookie supplementation
Daily consumption of cookie snack calorically equivalent to 57 grams of whole almonds.

Locations

Country	Name	City	State
United States	University of Missouri-Columbia	Columbia	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
University of Missouri-Columbia	Almond Board of California

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gut microbiome profile	16S rRNA sequencing	Baseline, week 6
Primary	Change in immune and inflammatory markers	Lymphocytes, granulocytes, monocytes, interleukins, cytokines, etc.	Over 6 weeks
Primary	Change in immune cell profile	Immunophenotyping	Over 6 weeks
Secondary	Body mass	Measured in kg	Baseline, week 3, and week 6
Secondary	Body composition	Fat mass and fat-free mass	Baseline, week 3, and week 6
Secondary	Anthropometrics	Waist circumference, hip circumference, thigh circumference	Baseline, week 3, and week 6
Secondary	Glucoregulation	Fasting glucose concentrations	Baseline and week 6
Secondary	Insulinemic biomarker concentrations	Fasting insulin and C-peptide concentrations	Baseline and week 6
Secondary	Lipid profile	LDL, HDL, triglycerides, total cholesterol	Baseline and week 6
Secondary	Blood pressure	Diastolic and systolic blood pressure	Baseline, week 3, week 6
Secondary	Dietary intake	24 hours dietary recall and food frequency questionnaires	Baseline, week 1, week 2, week 3, week 4, week 5, week 6
Secondary	24 hour appetite ratings	24 hour appetite rating survey	Baseline, week 6
Secondary	Physical activity	Activity assessment using Actigraphs	Baseline, week 6
Secondary	Sleep	Sleep monitors and questionnaires	Baseline, week 6
Secondary	Transcriptomics profiles	RNAseq	Baseline, week 6
Secondary	Palatability rating of foods	Hedonic general labelled magnitude scale (gLMS)	Baseline, week 3, week 6
Secondary	Acceptance rating of foods	9-point food action rating scale	Baseline, week 3, week 6