Summary

Eligibility
for people ages 18-65 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at UC Davis
Dates
study started
study ends around

Description

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.

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

Details

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.

Keywords

Immune System, Stress, Chronic Stress, Cardiovascular Health, peanut, immune function, pss10, inflammation, gut microbiota, Sodium Chloride, Peanuts, roasted, salted with skins, Isocaloric food

Eligibility

You can join if…

Open to people ages 18-65

  • 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

You CAN'T join 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:
  • 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

Location

  • Western Human Nutrition Research Center
    Davis California 95616 United States

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
USDA, Western Human Nutrition Research Center
ID
NCT07735221
Study Type
Interventional
Participants
Expecting 70 study participants
Last Updated