Immune ResponsewalnutimmuneNCT05915390
Walnut and Immunity Study
A study testing walnuts and Habitual diet in people with Immune Response and Upper Respiratory Tract Infection, run by Loma Linda University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Upper Respiratory Tract Infection
- What is being tested?
- walnuts and Habitual diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jun 2023to 18 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Loma Linda University School of Public Health
Loma Linda, California, 92350
About this study
Official title: Effects of Walnuts on Innate, Acquired and Gut Immunity in Older Adults With Overweight: A Randomized Controlled Trial
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.
Read the 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).
- Conditions
- Immune Response, Upper Respiratory Tract Infection
- Being tested
- walnuts, Habitual diet
- Keywords
- walnuts, Immunity, Inflammation
- Medical subject headings
- Respiratory Tract Infections, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
walnutsDietary supplement
walnuts will provide 15% of the total energy
Habitual dietDietary supplement
continue with habitual diet and abstain from walnuts
| Study group | Role | What they receive |
|---|---|---|
| walnut group | Active comparator | walnut group will receive 15% of their total energy as walnuts Receives: Dietary Supplement: walnuts |
| control group | Active comparator | continue with habitual diet and abstain from eating walnuts Receives: Dietary Supplement: Habitual diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline to 12 weeks
changes in lymphocyte activity
The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: baseline to 12 weeks
Secondary outcomes (1)
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.
Measured: baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2023
- Study start27 Jun 2023
- Primary completion18 Dec 2023
- Study completion18 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal women
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915390
- Sponsor's protocol ID
- 5220423
- Acronym
- walnutimmune
- Status last verified
- Sep 2024
- First submitted
- 16 May 2023
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Walnuts on Innate, Acquired and Gut Immunity in Older Adults With Overweight: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05915390
- Acronym / sponsor ID
- walnutimmune / 5220423
- Conditions
- Immune Response, Upper Respiratory Tract Infection
- Keywords
- walnuts, Immunity, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 27 Jun 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 18 Dec 2023 (actual)
- First posted
- 23 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This will be a parallel, free-living, randomized controlled trial with 54 men and post-menopausal women
| Arm | Type | Receives |
|---|---|---|
| walnut group | Active comparator | Dietary Supplement: walnutswalnut group will receive 15% of their total energy as walnuts |
| control group | Active comparator | Dietary Supplement: Habitual dietcontinue with habitual diet and abstain from eating walnuts |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| walnutswalnuts will provide 15% of the total energy | Dietary supplement | walnut group |
| Habitual dietcontinue with habitual diet and abstain from walnuts | Dietary supplement | control group |
Primary outcome
changes in lymphocyte populations
Time frame: 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
Time frame: baseline to 12 weeks
The production of lymphocytes will be measured in the supernatant using Enzyme linked immunosorbent assay (ELISA)
changes in cytokine production
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: baseline to 12 weeks
changes in Small chain fatty acids will be determined using high performance liquid chromatography-mass spectrometry (HPLC-MS)
1 secondary outcome
changes in upper respiratory infection questionnaire score
Time frame: baseline to 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing walnuts and Habitual diet in people with Immune Response and Upper Respiratory Tract Infection, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in lymphocyte populations (time frame: baseline to 12 weeks). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.