💬In plain words
What the trial is, and whether it could suit you
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.
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📋 Eligibility rules (as published)
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