walnutimmune: Walnut and Immunity Study

Sponsor

Loma Linda University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05915390

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.2

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Immune Response Upper Respiratory Tract Infection	Dietary Supplement: walnuts Dietary Supplement: Habitual diet	N/A

Detailed 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

54 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal womenThis will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal women

Masking:

Double (Investigator, Outcomes Assessor)

Masking Description:

The investigator and outcome assessor will not be aware which participant is in what arm. The participant and the care provider will know about the treatment allocation

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jun 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Jun 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: walnut group walnut group will receive 15% of their total energy as walnuts	Dietary Supplement: walnuts walnuts will provide 15% of the total energy
Active Comparator: control group continue with habitual diet and abstain from eating walnuts	Dietary Supplement: Habitual diet continue with habitual diet and abstain from walnuts

Arm

Intervention/Treatment

Active Comparator: walnut group

walnut group will receive 15% of their total energy as walnuts

Dietary Supplement: walnuts

walnuts will provide 15% of the total energy

Active Comparator: control group

continue with habitual diet and abstain from eating walnuts

Dietary Supplement: Habitual diet

continue with habitual diet and abstain from walnuts

Outcome Measures

Primary Outcome Measures

changes in lymphocyte populations [baseline to 12 weeks]
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
changes in lymphocyte activity [baseline to 12 weeks]
The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
changes in cytokine production [baseline to 12 weeks]
The cytokines produced due to lymphocyte activity will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
changes in serum inflammatory cytokine concentration [baseline to 12 weeks]
changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme-linked immunoassay (ELISA) will include hs-CRP, interleukin (IL)-1β, IL-6, TNF-α, IL-10, and IL-4.
changes in diversity of immune-modulating and butyrate -producing gut bacteria in feces [baseline to 12 weeks]
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.
Changes in concentration of Immunoglobulin A in feces [baseline to 12 weeks]
changes in Immunoglobulin A will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Changes in concentration of Calprotectin in feces [baseline to 12 weeks]
changes in Calprotectin will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Changes in concentration of small chain fatty in feces [baseline to 12 weeks]
changes in Small chain fatty acids will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)

Secondary Outcome Measures

changes in upper respiratory infection questionnaire score [baseline to 12 weeks]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

55 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loma Linda University School of Public Health	Loma Linda	California	United States	92350

Sponsors and Collaborators

Loma Linda University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Joan Sabate,DrPH, MD, Professor Nutrition and Epidemiology, Loma Linda University

ClinicalTrials.gov Identifier:

NCT05915390

Other Study ID Numbers:

5220423

First Posted:

Jun 23, 2023

Last Update Posted:

Jun 23, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Joan Sabate,DrPH, MD, Professor Nutrition and Epidemiology, Loma Linda University

walnuts

Immunity

Inflammation

Additional relevant MeSH terms:

Respiratory Tract Infections

Study Results

No Results Posted as of Jun 23, 2023