Walnut and Immunity Study

Immune Response Clinical Trial

— walnutimmune  

Official title:

Effects of Walnuts on Innate, Acquired and Gut Immunity in Older Adults With Overweight: A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05915390
• Other study ID #: 5220423
• Status: Recruiting
• Phase: N/A
• Start date: June 27, 2023
• Est. completion date: June 2025

Study information

• Verified date: September 2023
• Source: Loma Linda University
• Contact: Amandeep Kaur, MPH
• Phone: 9095584300
• Email: akaur1[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The main objective of the study is to determine if eating walnuts enhances immune function, in older free-living men and postmenopausal women with overweight.

Description:

The main objectives of our proposed study are to determine the effect of walnut consumption on innate, acquired, and gut immunity by assessing whether the ingestion of walnuts enhances immune function, in older free-living men and postmenopausal women with overweight. To accomplish these objectives, a randomized controlled, parallel design study is proposed with two groups consuming their habitual diet, but with one (Walnut group) receiving 15% of their total energy as walnuts and the other (Control group) abstaining from eating any walnuts and limited amounts of other tree nuts and peanuts (up to <1 serving/wk).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: June 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

Inclusion Criteria:

• Older men and post-menopausal women aged 55-75 years

• Have a BMI of 25-32

• Being able to commute to Loma Linda University.

• Not taking medication or supplements that affect immunity

Exclusion Criteria:

• Intolerance or allergy to walnuts

• Regular intake of walnuts and/or other nuts (>3 ounces per week).

• Immune system insufficiency or disease.

• Using immune boosting supplements.

• Exposure to antibiotics and corticoids immediately prior to the study.

• Participants with uncontrolled chronic diseases, and relevant psychiatric illness, including major depression will not be included in study

• Flu vaccination or Covid booster within past 6 months

Related Conditions & MeSH terms

• Immune Response
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Intervention

Dietary Supplement:
• walnuts
walnuts will provide 15% of the total energy
• Habitual diet
continue with habitual diet and abstain from walnuts

Locations

Country	Name	City	State
United States	Loma Linda University School of Public Health	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes in lymphocyte populations	Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells	baseline to 12 weeks
Primary	changes in lymphocyte activity	The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Primary	changes in cytokine production	The cytokines produced due to lymphocyte activity will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Primary	changes in serum inflammatory cytokine concentration	changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA) will include hs-CRP, interleukin (IL)-1ß, IL-6, TNF-a, IL-10, and IL-4.	baseline to 12 weeks
Primary	changes in diversity of immune-modulating and butyrate -producing gut bacteria in feces	DNA extraction from stool samples will be performed using QIAamp DNA Stool Mini kits.69 The QIIME (Quantitative Insights Into Microbial Ecology) software will be used to analyze 16S rRNA gene sequences and determine the effect of the intervention on microbial diversity at the phylum, genus, and operational taxonomic unit levels.	baseline to 12 weeks
Primary	Changes in concentration of Immunoglobulin A in feces	changes in Immunoglobulin A will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)	baseline to 12 weeks
Primary	Changes in concentration of Calprotectin in feces	changes in Calprotectin will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)	baseline to 12 weeks
Primary	Changes in concentration of small chain fatty in feces	changes in Small chain fatty acids will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)	baseline to 12 weeks
Secondary	changes in upper respiratory infection questionnaire score	Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire. The questionnaire will be completed daily by participants, either manually or electronically , throughout the 12-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome.	baseline to 12 weeks