Immune Response Clinical Trial
— walnutimmuneOfficial title:
Effects of Walnuts on Innate, Acquired and Gut Immunity in Older Adults With Overweight: A Randomized Controlled Trial
NCT number | NCT05915390 |
Other study ID # | 5220423 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 27, 2023 |
Est. completion date | June 2025 |
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.
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 |
Country | Name | City | State |
---|---|---|---|
United States | Loma Linda University School of Public Health | Loma Linda | California |
Lead Sponsor | Collaborator |
---|---|
Loma Linda University |
United States,
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 |
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