Immune ResponseNCT06159556
Effects of Peanuts on Immunity and Cardiometabolic Risk Factors
A study testing Peanut intake in people with Immune Response and Cardiometabolic Risk Factors, run by Loma Linda University at 1 site in United States.
Trial summary
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune Response, Cardiometabolic Risk Factors
- What is being tested?
- Peanut intake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2024to 26 Sep 2024
- 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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- adults between the ages of 18-70 years
Who cannot join
- known intolerance or allergy to peanuts
- bad dentures unable to chew peanuts
- regular intake of peanuts and/or other nuts (>3 ounces/week)
- use of immune-boosting supplements
- exposure to antibiotics and corticoids immediately prior to the study
- use of other medications or supplements that can interfere with the immune functions
- Individuals that received any vaccination (i.e flu or Covid 19) 6 months prior to the start of the study
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: Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.
Read the detailed description
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . To accomplish this objective, a human dietary intervention trial (RCT) with peanuts is proposed. The proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. This study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.
- Conditions
- Immune Response, Cardiometabolic Risk Factors
- Being tested
- Peanut intake
- Keywords
- Peanuts, Immunity, heart disease
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanut intakeOther
Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Peanut group | Active comparator | Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks Receives: Other: Peanut intake |
| control group | No intervention | Participants will continue with habitual diet and abstain from eating peanuts |
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, Naive 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)-1B, IL-6, TNF a, IL-10 and IFN-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3
Measured: baseline to 12 weeks
Changes in the serum lipid concentration
This is a composite measurement which will measure the changes in the levels of serum low density cholesterol, high density cholesterol, non- high density cholesterol and triglycerides
Measured: baseline to 12 weeks
Changes in insulin resistance
Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)
Measured: baseline to 12 weeks
Changes in Hemoglobin A1c
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
Measured: baseline to 12 weeks
Changes in body weight
A change in body weight for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
Measured: baseline to 12 weeks
changes in systolic and diastolic blood pressure
Seated systolic and diastolic blood pressure will be measured at baseline and end of intervention utilizing Omron -Model HEM-7471 C device. Three measurements will be taken after a five-minute rest period, 1 minute apart, and the last two recordings will be averaged for analysis.
Measured: baseline to 12 weeks
changes in percentage body fat
A change in the percentage of body fat for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
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 posted6 Dec 2023
- Study start31 Jan 2024
- Primary completion26 Sep 2024
- Study completion26 Sep 2024
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.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- 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
- The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- California Walnut Commission
- Responsible party
- Principal investigator, Joan Sabate,DrPH, MD, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06159556
- Sponsor's protocol ID
- 5230190
- Status last verified
- Sep 2024
- First submitted
- 28 Nov 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
- Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06159556
- Acronym / sponsor ID
- 5230190
- Conditions
- Immune Response, Cardiometabolic Risk Factors
- Keywords
- Peanuts, Immunity, heart disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- California Walnut Commission
- Study start
- 31 Jan 2024 (actual)
- Primary completion
- 26 Sep 2024 (actual)
- Study completion
- 26 Sep 2024 (actual)
- First posted
- 6 Dec 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 aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.
Detailed description
The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . To accomplish this objective, a human dietary intervention trial (RCT) with peanuts is proposed. The proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. This study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
| Arm | Type | Receives |
|---|---|---|
| Peanut group | Active comparator | Other: Peanut intakeParticipants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks |
| control group | No intervention | –Participants will continue with habitual diet and abstain from eating peanuts |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- adults between the ages of 18-70 years
Key exclusion criteria (7 listed)
- known intolerance or allergy to peanuts
- bad dentures unable to chew peanuts
- regular intake of peanuts and/or other nuts (>3 ounces/week)
- use of 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 |
|---|---|---|
| Peanut intakeParticipants will consume 2 ounces of peanuts/peanut butter for 12 weeks | Other | Peanut 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, Naive 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)-1B, IL-6, TNF a, IL-10 and IFN-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3
Changes in the serum lipid concentration
Time frame: baseline to 12 weeks
This is a composite measurement which will measure the changes in the levels of serum low density cholesterol, high density cholesterol, non- high density cholesterol and triglycerides
Changes in insulin resistance
Time frame: baseline to 12 weeks
Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)
Changes in Hemoglobin A1c
Time frame: baseline to 12 weeks
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
Changes in body weight
Time frame: baseline to 12 weeks
A change in body weight for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
changes in systolic and diastolic blood pressure
Time frame: baseline to 12 weeks
Seated systolic and diastolic blood pressure will be measured at baseline and end of intervention utilizing Omron -Model HEM-7471 C device. Three measurements will be taken after a five-minute rest period, 1 minute apart, and the last two recordings will be averaged for analysis.
changes in percentage body fat
Time frame: baseline to 12 weeks
A change in the percentage of body fat for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
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 Peanut intake in people with Immune Response and Cardiometabolic Risk Factors, 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 1 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 10 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.