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

August 13, 2026 updated by: USDA, Western Human Nutrition Research Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • California
      • Davis, California, United States, 95616
        • Western Human Nutrition Research Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ryan Snodgrass, PhD
        • Sub-Investigator:
          • Danielle Lemay, PhD
        • Sub-Investigator:
          • Mary Kable, PhD
        • Sub-Investigator:
          • Kevin Laugero, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Peanut Intervention followed by corn chips Intervention
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
42g roasted salted peanuts with skins consumed daily
Other: Isocaloric food
Corn chips (45g)
Experimental: Corn chip Intervention followed by Peanut Intervention
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
42g roasted salted peanuts with skins consumed daily
Other: Isocaloric food
Corn chips (45g)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
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).
Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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:
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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
Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, 12 weeks
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).
Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Baseline, 4 weeks, 8 weeks, 12 weeks
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.
Baseline, 4 weeks, 8 weeks, 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in stool consistency
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in stool metrics
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to determine the whole stool weight.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in bowel movement frequency
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in Gastrointestinal (GI) symptoms
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut microbial diversity
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
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
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).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut inflammatory markers
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Participants will provide stool samples at 4 times throughout the study. Stool samples will be used to measure the inflammatory marker, fecal calprotectin.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in salivary cortisol
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks

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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary cortisol levels
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary cortisol will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary epinephrine levels
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary epinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary norepinephrine levels
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary norepinephrine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in urinary creatinine levels
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Before and after each intervention, 12-hour overnight urinary creatinine levels will be measured.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in resting blood pressure
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect resting blood pressure (systolic and diastolic) in mmHg (millimeters of mercury).
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in dietary intake
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in Body Weight
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Research team will collect weight in kg.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in white blood cell count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
White blood cell (WBC) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in lymphocyte count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Lymphocyte (LY) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in monocyte count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Monocyte (MO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in neutrophil granulocyte count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Neutrophil granulocyte (NE) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in eosinophil count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Eosinophil (EO) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in basophil count
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Basophil (BA) count will be measured by a DxH 520 Hematology analyzer.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of triglycerides
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including triglycerides will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of total cholesterol
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including total cholesterol will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of HDL-cholesterol
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including HDL-cholesterol (HDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of LDL-cholesterol
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Lipid-related markers including LDL-cholesterol (LDL-C) will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Change in levels of glucose
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
Plasma glucose will be measured by auto-analyzer, Cobas Integra 400+ instrument.
Baseline, 4 weeks, 8 weeks, and 12 weeks
Changes in gut transit time
Time Frame: Baseline, 4 weeks, 8 weeks, and 12 weeks
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.
Baseline, 4 weeks, 8 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
USDA, Western Human Nutrition Research Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ryan Snodgrass, PhD, United States Department of Agriculture - Western Human Nutrition Research Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 4, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 29, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2280324

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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