Impact of Peanut Consumption on Stress, Immune Function, Inflammation, and Cardiovascular Health in High-Stress Individuals

NCT07735221 | Not Yet Recruiting

• 1 other identifier: 2280324
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Immune System; Stress; Chronic Stress; Cardiovascular Health

Keywords

peanut; stress; immune function; cardiovascular health; chronic stress; pss10; inflammation; gut microbiota

Outcome Measures

Primary Outcomes (28)

• 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.

  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).

  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.

  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.

  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.

  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

  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

  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

  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

  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:

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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

  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.

  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).

  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.

  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.

  Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcomes (26)

• Changes in stool consistency

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Changes in stool metrics

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Changes in bowel movement frequency

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Changes in Gastrointestinal (GI) symptoms

  Baseline, 4 weeks, 8 weeks, and 12 weeks

• Changes in gut microbial diversity

  Baseline, 4 weeks, 8 weeks, and 12 weeks

Study Arms (2)

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.

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.

Other: Peanuts, roasted, salted with skins; Other: Isocaloric food

Interventions

Peanuts, roasted, salted with skins OTHER

42g roasted salted peanuts with skins consumed daily

Corn chip Intervention followed by Peanut Intervention; Peanut Intervention followed by corn chips Intervention

Isocaloric food OTHER

Corn chips (45g)

Corn chip Intervention followed by Peanut Intervention; Peanut Intervention followed by corn chips Intervention

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females
• years old
• BMI ≥ 18.5 kg/m2 and ≤ 39.9 kg/ m2
• Recruitment will be based on Perceived Stress Scale - 4 (PSS-4) score

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• USDA, Western Human Nutrition Research Center: lead

Study Sites (1)

Western Human Nutrition Research Center

Davis, California, 95616, United States

Location

MeSH Terms

Conditions

Inflammation

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Ryan Snodgrass, PhD

  United States Department of Agriculture - Western Human Nutrition Research Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ellen Bonnel, PhD

CONTACT

530-752-4184; elbonnel@ucdavis.edu

Ione Summers, B.S.

CONTACT

530-754-8544; iosummerssteffes@ucdavis.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: July 29, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): August 1, 2028
• Last Updated: July 29, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)