Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| walnut group | Active Comparator | walnut group will receive 15% of their total energy as walnuts |
|
| control group | Active Comparator | continue with habitual diet and abstain from eating walnuts |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| walnuts | Dietary Supplement | walnuts will provide 15% of the total energy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| changes in lymphocyte activity | The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA) | baseline to 12 weeks |
| 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 |
| 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. | baseline to 12 weeks |
| 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 |
| Changes in concentration of Immunoglobulin A in feces | changes in Immunoglobulin A will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Loma Linda University School of Public Health | Loma Linda | California | 92350 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
This will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal women
Not provided
Not provided
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
| Habitual diet |
| Dietary Supplement |
continue with habitual diet and abstain from walnuts |
|
| baseline to 12 weeks |
| 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 |
| 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 |