Back to resultsWalnut and Immunity Study (walnutimmune)
Primary Purpose
Immune Response, Upper Respiratory Tract Infection
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
walnuts
Habitual diet
Sponsored by
About this trial
This is an interventional prevention trial for Immune Response focused on measuring walnuts, Immunity, Inflammation
Eligibility Criteria
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
Sites / Locations
- Loma Linda University School of Public HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
walnut group
control group
Arm Description
walnut group will receive 15% of their total energy as walnuts
continue with habitual diet and abstain from eating walnuts
Outcomes
Primary Outcome Measures
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
changes in lymphocyte activity
The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
changes in cytokine production
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
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
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
changes in Immunoglobulin A will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Changes in concentration of Calprotectin in feces
changes in Calprotectin will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05915390
Brief Title
Walnut and Immunity Study
Acronym
walnutimmune
Official Title
Effects of Walnuts on Innate, Acquired and Gut Immunity in Older Adults With Overweight: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 27, 2023 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Response, Upper Respiratory Tract Infection
Keywords
walnuts, Immunity, Inflammation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal women
Masking
InvestigatorOutcomes 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
Allocation
Randomized
Enrollment
54 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
walnut group
Arm Type
Active Comparator
Arm Description
walnut group will receive 15% of their total energy as walnuts
Arm Title
control group
Arm Type
Active Comparator
Arm Description
continue with habitual diet and abstain from eating walnuts
Intervention Type
Dietary Supplement
Intervention Name(s)
walnuts
Intervention Description
walnuts will provide 15% of the total energy
Intervention Type
Dietary Supplement
Intervention Name(s)
Habitual diet
Intervention Description
continue with habitual diet and abstain from walnuts
Primary Outcome Measure Information:
Title
changes in lymphocyte populations
Description
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naïve and memory cells and B cells
Time Frame
baseline to 12 weeks
Title
changes in lymphocyte activity
Description
The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
Time Frame
baseline to 12 weeks
Title
changes in cytokine production
Description
The cytokines produced due to lymphocyte activity will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
Time Frame
baseline to 12 weeks
Title
changes in serum inflammatory cytokine concentration
Description
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.
Time Frame
baseline to 12 weeks
Title
changes in diversity of immune-modulating and butyrate -producing gut bacteria in feces
Description
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.
Time Frame
baseline to 12 weeks
Title
Changes in concentration of Immunoglobulin A in feces
Description
changes in Immunoglobulin A will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Time Frame
baseline to 12 weeks
Title
Changes in concentration of Calprotectin in feces
Description
changes in Calprotectin will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Time Frame
baseline to 12 weeks
Title
Changes in concentration of small chain fatty in feces
Description
changes in Small chain fatty acids will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
Time Frame
baseline to 12 weeks
Secondary Outcome Measure Information:
Title
changes in upper respiratory infection questionnaire score
Description
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.
Time Frame
baseline to 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amandeep Kaur, MPH
Phone
9095584300
Ext
47169
Email
akaur1@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joan Sabate, DrPH
Phone
9095584300
Ext
47238
Email
jsabate@llu.edu
Facility Information:
Facility Name
Loma Linda University School of Public Health
City
Loma Linda
State/Province
California
ZIP/Postal Code
92350
Country
United States
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Walnut and Immunity Study
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