An interventional study of Peanuts, roasted, salted with skins and Isocaloric food in Immune System, Stress and Chronic Stress, sponsored by USDA, Western Human Nutrition Research Center. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-11.
Sponsored by USDA, Western Human Nutrition Research Center · Not applicable, Interventional, and Basic science
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.
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.
3,536 studies on the registry are indexed under Inflammation; 642 are open to participants now.
This study's planned enrollment of 70 is above the median of 50 across 2,577 interventional studies indexed under Inflammation.
Browse Inflammation studies →USDA, Western Human Nutrition Research Center is the lead sponsor of 54 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
42g roasted salted peanuts with skins consumed daily
Corn chips (45g)
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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:
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
Research team will collect weight in kg.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Plan to share: No
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USDA, Western Human Nutrition Research Center