Immune SystemNCT07735221
Impact of Peanut Consumption on Stress, Immune Function, Inflammation, and Cardiovascular Health in High-Stress Individuals
A study testing Peanuts, roasted, salted with skins and Isocaloric food in people with Immune System and Stress, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial summary
The purpose of this research is to determine whether peanut consumption improves indicators of cardiovascular disease (CVD) risk in human subjects following the consumption of study foods. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Immune System, Stress, Chronic Stress
- What is being tested?
- Peanuts, roasted, salted with skins and Isocaloric food
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2026to Aug 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Males and females
- 18-65 years old
- BMI ≥ 18.5 kg/m2 and ≤ 39.9 kg/ m2
- Recruitment will be based on Perceived Stress Scale - 4 (PSS-4) score
Who cannot join
- Less than 18 and over 65 years old
- Pregnant or lactating women
- Adults who rely on prescription medication that may influence study variables, apart from birth control
- BMI < 18.5 kg/m2 and > 39.9 kg/m2
- Smokers who currently use tobacco- or marijuana-containing products including e-cigarettes, vape pens, pod mods, tanks, and electronic nicotine delivery devices (ENDS)
- Habitual consumption of nuts, nut butters, nut powders, nut side dishes, nut bars or other nut products
Show all 30Show fewer
- Known food allergies (milk, eggs, fish, shellfish, tree nuts, peanuts, wheat, soybeans, sesame, corn) due to samples not prepared in a hypoallergenic environment
- Currently living in close contact with individuals who have an allergy to peanuts, in order to avoid exposing these individuals to an allergen
- Self-reported history of difficulties with blood drawing procedures including prior fainting or dizziness, or veins assessed as not suitable for four separate venipunctures by licensed phlebotomist
- Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:
- Diabetes mellitus, cardiovascular disease, cancer, gastrointestinal disorders, kidney disease, liver disease, bleeding disorders, asthma, autoimmune disorders, hypertension, osteoporosis
- Recent minor surgery (within 4 weeks) or major surgery (within 16 weeks)
- Known gallbladder disease or history of cholecystectomy
- History of gastrointestinal surgery, including gastric bypass surgery or resection
- Diagnosis of irritable bowel syndrome
- Recent antibiotic therapy (within 4 weeks)
- Recent hospitalization (within 4 weeks)
- Current participation in another research study
- Has HIV/AIDS, hepatitis, or another disease that affects the immune system
- Gives regular blood donations and is unwilling to stop during the study
- Blood Pressure ≥ 140 mmHg systolic or 90 mmHg diastolic
- Current diagnoses of an eating disorder (ex. anorexia, bulimia, etc.)
- High - very high triglyceride levels: ≥ 300 mg/dL
- Adults who are unable to consent, individuals who are not yet adults (infants, children and teenagers), pregnant women and prisoners will be excluded from participation in the study
- Participants who are unwilling to collect and transport urine, stool and saliva samples
- Abnormal hemoglobin and/or hematocrit levels
- Abnormal liver function (defined as liver enzymes that are >200% of upper limit (ALT upper limit is 43 U/L or Aspartate transaminase (AST) upper limit is 54 U/L)
- Unwillingness to discontinue probiotic, prebiotic, fiber, or other supplements (except RDA-level vitamin and mineral supplements) during the study
- Unwilling to consume study foods
- Alcohol consumption > 20 g/day
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Western Human Nutrition Research Center
Davis, California, 95616
Ellen Bonnel, PhD, 530-752-4184, elbonnel@ucdavis.edu
Ione Summers, B.S., 530-754-8544, iosummerssteffes@ucdavis.edu
About this study
Official title: Effects of Peanut Consumption on Physiological and Psychosocial Stress, Circulating Immune Cell Status, Markers of Inflammation and Cardiovascular Disease Risk, and Gastrointestinal Health in High-Stress Individuals
The purpose of this research is to determine whether peanut consumption improves indicators of cardiovascular disease (CVD) risk in human subjects following the consumption of study foods.
Read the detailed description
The overall goal of the proposed study is to determine whether peanut consumption improves indices of cardiovascular disease (CVD) risk in human subjects with high levels of perceived chronic stress. Chronic stress is a growing public health concern and is associated with adverse health outcomes, including CVD. Stress, experienced when a person feels that environmental, physiological, or psychosocial demands tax or exceed their adaptive capacity, triggers a coordinated response from the sympathetic nervous system (SNS) and hypothalamic- pituitary- adrenal (HPA) axis increasing blood pressure, driving systemic inflammation, and affecting the immune system by accelerating the output of disease-promoting immune cells from bone marrow.
- Conditions
- Immune System, Stress, Chronic Stress, Cardiovascular Health
- Being tested
- Peanuts, roasted, salted with skins, Isocaloric food
- Keywords
- peanut, stress, immune function, cardiovascular health, chronic stress, pss10, inflammation, gut microbiota
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peanuts, roasted, salted with skinsOther
42g roasted salted peanuts with skins consumed daily
Isocaloric foodOther
Corn chips (45g)
| Study group | Role | What they receive |
|---|---|---|
| Peanut Intervention followed by corn chips Intervention | Experimental | Participants will be asked to consume 42g of peanuts with skin daily for 4 weeks. Following a 4-week washout, the participant will then be asked to consume 45g of corn chips daily for 4 weeks. Receives: Other: Peanuts, roasted, salted with skins; Other: Isocaloric food |
| Corn chip Intervention followed by Peanut Intervention | Experimental | The participant will be asked to consume 45g of corn chips daily for 4 weeks. Following a 4-week washout, the participant will be then asked to consume 42g of peanuts with skin daily for 4 weeks. Receives: Other: Peanuts, roasted, salted with skins; Other: Isocaloric food |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in psychosocial stress over time
The PSS-10 will be administered 4 times during the study. The 10-item Perceived Stress Scale (PSS-10) is a validated, standard instrument used to assess subjective perceptions of chronic psychological stress (i.e., excessive demands, insufficient coping resources, and a perceived lack of control).
The minimum score is 0 and the maximum score is 40. Higher scores indicate greater severity of psychosocial stress.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of allostatic load following dietary interventions
Before and after each intervention, cumulative physiological stress load, also referred to as allostatic load (AL), will be calculated. AL will be derived from 12-h overnight urinary cortisol, norepinephrine, and epinephrine levels (corrected for urinary creatinine levels), resting systolic and diastolic blood pressure, and overnight fasted waist-to-hip ratio, fasting serum levels of high-sensitivity C-reactive protein (hs-CRP), cholesterol, HDL-cholesterol, fasting plasma dehydroepiandrosterone sulfate (DHEA-S), and whole blood glycohemoglobin (HbA1c).
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte gene expression
Total monocytes isolated from human peripheral blood mononuclear cells (PBMCs) at baseline and post-intervention will be collected, and their global gene expression will be analyzed by ribonucleic acid (RNA) sequencing.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytokine and interferon production in PBMCs
Monocytes isolated from human peripheral blood mononuclear cells (PBMCs) will be challenged with and without toll-like receptor ligands to assess cytokine and interferon production in low- and high-stress subjects at baseline and after intervention.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of cytotoxicity of peripheral natural killer cells
The cytotoxicity of peripheral natural killer (NK) cells isolated from subject's peripheral blood mononuclear cells (PBMCs) of low- and high-stress individuals at baseline and after intervention will be assessed using an ex vivo cytotoxicity assay with human erythroleukemic cell line (K562) target cells.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon-gamma
Interferon-gamma (IFN-γ) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of tumor necrosis factors alpha and beta
Tumor necrosis factors alpha and beta (TNF-α, TNF-β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interleukins
A panel of interleukins: (IL) (IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of fibroblast growth factor
Fibroblast growth factor (FGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of granulocyte-macrophage colony-stimulating factor
Granulocyte-macrophage colony-stimulating factor (GM-CSF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery:
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of thymus and activation-regulated chemokine
Thymus and activation-regulated chemokine (TARC). will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage inflammatory proteins-1 alpha and beta
Macrophage inflammatory proteins-1 alpha and beta (MIP-1α, MIP-1β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of macrophage-derived chemokine
Macrophage-derived chemokine (MDC) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte chemoattractant proteins-1 and -4
Monocyte chemoattractant proteins-1 and -4 (MCP-1, MCP-4) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of interferon gamma-induced protein-10
Interferon gamma-induced protein-10 (IP-10) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of eotaxin and eotaxin-3
Eotaxin and eotaxin-3 will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of C-reactive protein
C-reactive protein (CRP) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of intercellular adhesion molecule-1
Intercellular adhesion molecule-1 (ICAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of placental growth factor
Placental growth factor (PlGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of serum amyloid A
Serum amyloid A (SAA) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of angiopoietin-1 receptor
Angiopoietin-1 receptor (Tie-2) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular cell adhesion molecule-1
Vascular cell adhesion molecule-1 (VCAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factors A, C, and D
Vascular endothelial growth factors A, C, and D (VEGF-A, VEGF-C, VEGF-D) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of vascular endothelial growth factor receptor-1
Vascular endothelial growth factor receptor-1 (VEGFR-1/Flt-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change from baseline of monocyte phenotype
Classical monocytes, intermediate monocytes, and non-classical monocytes, will be identified by leukocyte common antigen (CD45+), Low-density lipoprotein receptor-related protein 1 (CD91+), cluster of differentiation 14 (CD14), cluster of differentiation 16 (CD16), and cluster of differentiation 3 (lin-CD3)/cluster of differentiation 66b (CD66b)/neural cell adhesion molecule (CD56)/cluster of differentiation 19 (CD19) using flow cytometry.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of monocyte functional profile
Cellular activation of classical monocytes, intermediate monocytes, and non-classical monocytes will be assessed by expression of cluster of differentiation 11b (CD11b) and cluster of differentiation 163 (CD163).
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell phenotype
Natural killer (NK) cells will be identified by CD45+, cluster of differentiation 56+ (CD56+), and lin-CD3/CD66b/CD14/CD19 using flow cytometry.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Change from baseline of natural killer cell functional profile
Natural killer (NK) cell maturation status and cytotoxic potential via CD16, cluster of differentiation 57 (CD57), killer cell lectin-like receptor K1 (NKG2D), and cluster of differentiation 159 (NKG2A) will be analyzed using flow cytometry.
Measured: Baseline, 4 weeks, 8 weeks, 12 weeks
Secondary outcomes (27)
Changes in stool consistency
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to confirm the stool consistency reported by the study subject.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool metrics
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the whole stool weight.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in bowel movement frequency
During the week prior to each intervention and the final week of each intervention, participants will maintain a stool diary for recording frequency of bowel movements.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut transit time
During the week prior to each intervention and the final week of each intervention, participants will consume a muffin containing blue food dye. Participants will log the date and time of consumption, and will log each bowel movement until stool color changes. This will be used to measure gut transit time.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in Gastrointestinal (GI) symptoms
During the week prior to each intervention and the final week of each intervention, a short GI Symptoms Questionnaire will be administered via Qualtrics to record occurrence of gastric symptoms.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut microbial diversity
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the microbial community composition by 16-subunit ribosomal ribonucleic acid (16S rRNA) amplicon sequence analysis.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool short chain fatty acids
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the amount of fecal short chain fatty acids (SCFAs).
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut inflammatory markers
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the inflammatory marker, fecal calprotectin.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in salivary cortisol
To assess waking and diurnal cortisol fluctuations, saliva will be collected at home at selected times upon waking and before bedtime. The waking saliva sample must be collected within 10-15 minutes of waking. Following the waking sample, participants will be asked to collect additional saliva samples at 15, 30, 45, and 60 minutes after the waking sample, as well as a saliva sample before bedtime.
In total, participants will return 24 saliva samples (6 per visit) throughout the study.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary cortisol levels
Before and after each intervention, 12-hour overnight urinary cortisol will be measured.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary epinephrine levels
Before and after each intervention, 12-hour overnight urinary epinephrine levels will be measured.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary norepinephrine levels
Before and after each intervention, 12-hour overnight urinary norepinephrine levels will be measured.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary creatinine levels
Before and after each intervention, 12-hour overnight urinary creatinine levels will be measured.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in resting blood pressure
Research team will collect resting blood pressure (systolic and diastolic) in mmHg (millimeters of mercury).
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in dietary intake
Dietary intake will be assessed by using the Automated Self-Administered 24-hour (ASA24®) dietary assessment tool, a web-based tool that enables multiple, automatically coded, self-administered 24-hour recalls. Three dietary recalls will be conducted in the week preceding and the final week of each intervention period, for a total of 12, 24-hour dietary recalls.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
Research team will collect weight in kg.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in white blood cell count
White blood cell (WBC) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in neutrophil granulocyte count
Neutrophil granulocyte (NE) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of triglycerides
Lipid-related markers including triglycerides will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of total cholesterol
Lipid-related markers including total cholesterol will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of HDL-cholesterol
Lipid-related markers including HDL-cholesterol (HDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of LDL-cholesterol
Lipid-related markers including LDL-cholesterol (LDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of glucose
Plasma glucose will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Measured: Baseline, 4 weeks, 8 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2026
- Study startSep 2026 (estimated)
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Ryan Snodgrass, PhD, Principal investigator, United States Department of Agriculture - Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07735221
- Sponsor's protocol ID
- 2280324
- Status last verified
- Sep 2026
- First submitted
- 4 Aug 2025
- Last updated
- 11 Sep 2026
- 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 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Peanut Consumption on Physiological and Psychosocial Stress, Circulating Immune Cell Status, Markers of Inflammation and Cardiovascular Disease Risk, and Gastrointestinal Health in High-Stress Individuals
- ClinicalTrials.gov ID
- NCT07735221
- Acronym / sponsor ID
- 2280324
- Conditions
- Immune System, Stress, Chronic Stress, Cardiovascular Health
- Keywords
- peanut, stress, immune function, cardiovascular health, chronic stress, pss10, inflammation, gut microbiota
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Study start
- Sep 2026 (estimated)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 29 Jul 2026 (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 purpose of this research is to determine whether peanut consumption improves indicators of cardiovascular disease (CVD) risk in human subjects following the consumption of study foods.
Detailed description
The overall goal of the proposed study is to determine whether peanut consumption improves indices of cardiovascular disease (CVD) risk in human subjects with high levels of perceived chronic stress. Chronic stress is a growing public health concern and is associated with adverse health outcomes, including CVD. Stress, experienced when a person feels that environmental, physiological, or psychosocial demands tax or exceed their adaptive capacity, triggers a coordinated response from the sympathetic nervous system (SNS) and hypothalamic- pituitary- adrenal (HPA) axis increasing blood pressure, driving systemic inflammation, and affecting the immune system by accelerating the output of disease-promoting immune cells from bone marrow.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peanut Intervention followed by corn chips Intervention | Experimental | Other: Peanuts, roasted, salted with skins, Other: Isocaloric foodParticipants will be asked to consume 42g of peanuts with skin daily for 4 weeks. Following a 4-week washout, the participant will then be asked to consume 45g of corn chips daily for 4 weeks. |
| Corn chip Intervention followed by Peanut Intervention | Experimental | Other: Peanuts, roasted, salted with skins, Other: Isocaloric foodThe participant will be asked to consume 45g of corn chips daily for 4 weeks. Following a 4-week washout, the participant will be then asked to consume 42g of peanuts with skin daily for 4 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females
- 18-65 years old
- BMI ≥ 18.5 kg/m2 and ≤ 39.9 kg/ m2
- Recruitment will be based on Perceived Stress Scale - 4 (PSS-4) score
Key exclusion criteria (30 listed)
- Less than 18 and over 65 years old
- Pregnant or lactating women
- Adults who rely on prescription medication that may influence study variables, apart from birth control
- BMI < 18.5 kg/m2 and > 39.9 kg/m2
- Smokers who currently use tobacco- or marijuana-containing products including e-cigarettes, vape pens, pod mods, tanks, and electronic nicotine delivery devices (ENDS)
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 |
|---|---|---|
| Peanuts, roasted, salted with skins42g roasted salted peanuts with skins consumed daily | Other | Corn chip Intervention followed by Peanut Intervention, Peanut Intervention followed by corn chips Intervention |
| Isocaloric foodCorn chips (45g) | Other | Corn chip Intervention followed by Peanut Intervention, Peanut Intervention followed by corn chips Intervention |
Primary outcome
Change in psychosocial stress over time
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
The PSS-10 will be administered 4 times during the study. The 10-item Perceived Stress Scale (PSS-10) is a validated, standard instrument used to assess subjective perceptions of chronic psychological stress (i.e., excessive demands, insufficient coping resources, and a perceived lack of control). The minimum score is 0 and the maximum score is 40. Higher scores indicate greater severity of psychosocial stress.
Change from baseline of allostatic load following dietary interventions
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, cumulative physiological stress load, also referred to as allostatic load (AL), will be calculated. AL will be derived from 12-h overnight urinary cortisol, norepinephrine, and epinephrine levels (corrected for urinary creatinine levels), resting systolic and diastolic blood pressure, and overnight fasted waist-to-hip ratio, fasting serum levels of high-sensitivity C-reactive protein (hs-CRP), cholesterol, HDL-cholesterol, fasting plasma dehydroepiandrosterone sulfate (DHEA-S), and whole blood glycohemoglobin (HbA1c).
Change from baseline of monocyte gene expression
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Total monocytes isolated from human peripheral blood mononuclear cells (PBMCs) at baseline and post-intervention will be collected, and their global gene expression will be analyzed by ribonucleic acid (RNA) sequencing.
Change from baseline of cytokine and interferon production in PBMCs
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocytes isolated from human peripheral blood mononuclear cells (PBMCs) will be challenged with and without toll-like receptor ligands to assess cytokine and interferon production in low- and high-stress subjects at baseline and after intervention.
Change from baseline of cytotoxicity of peripheral natural killer cells
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
The cytotoxicity of peripheral natural killer (NK) cells isolated from subject's peripheral blood mononuclear cells (PBMCs) of low- and high-stress individuals at baseline and after intervention will be assessed using an ex vivo cytotoxicity assay with human erythroleukemic cell line (K562) target cells.
Change from baseline of interferon-gamma
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon-gamma (IFN-γ) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of tumor necrosis factors alpha and beta
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Tumor necrosis factors alpha and beta (TNF-α, TNF-β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of interleukins
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
A panel of interleukins: (IL) (IL-1α, IL-1β, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-10, IL-12/IL-23p40, IL-12p70, IL-13, IL-15, IL-16, IL-17A) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of fibroblast growth factor
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Fibroblast growth factor (FGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of granulocyte-macrophage colony-stimulating factor
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Granulocyte-macrophage colony-stimulating factor (GM-CSF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery:
Change from baseline of thymus and activation-regulated chemokine
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Thymus and activation-regulated chemokine (TARC). will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of macrophage inflammatory proteins-1 alpha and beta
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage inflammatory proteins-1 alpha and beta (MIP-1α, MIP-1β) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of macrophage-derived chemokine
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Macrophage-derived chemokine (MDC) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of monocyte chemoattractant proteins-1 and -4
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte chemoattractant proteins-1 and -4 (MCP-1, MCP-4) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of interferon gamma-induced protein-10
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Interferon gamma-induced protein-10 (IP-10) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of eotaxin and eotaxin-3
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Eotaxin and eotaxin-3 will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of C-reactive protein
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
C-reactive protein (CRP) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of intercellular adhesion molecule-1
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Intercellular adhesion molecule-1 (ICAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of placental growth factor
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Placental growth factor (PlGF) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of serum amyloid A
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Serum amyloid A (SAA) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of angiopoietin-1 receptor
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Angiopoietin-1 receptor (Tie-2) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of vascular cell adhesion molecule-1
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular cell adhesion molecule-1 (VCAM-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of vascular endothelial growth factors A, C, and D
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factors A, C, and D (VEGF-A, VEGF-C, VEGF-D) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of vascular endothelial growth factor receptor-1
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Vascular endothelial growth factor receptor-1 (VEGFR-1/Flt-1) will be measured before and after each intervention using the V-PLEX Human Biomarker 40-Plex Kit from Meso Scale Discovery
Change from baseline of monocyte phenotype
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Classical monocytes, intermediate monocytes, and non-classical monocytes, will be identified by leukocyte common antigen (CD45+), Low-density lipoprotein receptor-related protein 1 (CD91+), cluster of differentiation 14 (CD14), cluster of differentiation 16 (CD16), and cluster of differentiation 3 (lin-CD3)/cluster of differentiation 66b (CD66b)/neural cell adhesion molecule (CD56)/cluster of differentiation 19 (CD19) using flow cytometry.
Change from baseline of monocyte functional profile
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Cellular activation of classical monocytes, intermediate monocytes, and non-classical monocytes will be assessed by expression of cluster of differentiation 11b (CD11b) and cluster of differentiation 163 (CD163).
Change from baseline of natural killer cell phenotype
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cells will be identified by CD45+, cluster of differentiation 56+ (CD56+), and lin-CD3/CD66b/CD14/CD19 using flow cytometry.
Change from baseline of natural killer cell functional profile
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
Natural killer (NK) cell maturation status and cytotoxic potential via CD16, cluster of differentiation 57 (CD57), killer cell lectin-like receptor K1 (NKG2D), and cluster of differentiation 159 (NKG2A) will be analyzed using flow cytometry.
27 secondary outcomes
Changes in stool consistency
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool metrics
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in bowel movement frequency
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut transit time
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in Gastrointestinal (GI) symptoms
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut microbial diversity
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool short chain fatty acids
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut inflammatory markers
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in salivary cortisol
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary cortisol levels
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary epinephrine levels
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary norepinephrine levels
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary creatinine levels
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in resting blood pressure
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in dietary intake
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in white blood cell count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in neutrophil granulocyte count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of triglycerides
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of total cholesterol
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of HDL-cholesterol
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of LDL-cholesterol
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of glucose
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Immune System
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Not yet recruitingPhase 2
Study of YKST02 in Adults With Relapsed or Refractory Multiple Myeloma
Relapsed or Refractory Multiple Myeloma (RRMM)
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
RecruitingPhase 2
Engaging T-cells to Eliminate MRD in Newly Diagnosed Myeloma Optimizing Response With Talquetmab and Teclistamab (ROTATE)
Multiple Myeloma
Active, not recruitingPhase 3
A Phase III Study of Eque-cel in Subjects With Len-refractory RRMM (FUMANBA-03)
Multiple Myeloma
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.
Ryan Snodgrass, PhD principal investigator
United States Department of Agriculture - Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peanuts, roasted, salted with skins and Isocaloric food in people with Immune System and Stress, run by USDA, Western Human Nutrition Research Center 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 30 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: looking for participants now, as of the sponsor's last update on 11 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ellen Bonnel, PhD (530-752-4184, elbonnel@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in psychosocial stress over time (time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks). The study lists 28 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 11 Sep 2026.