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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Peanuts, roasted, salted with skins
  42g roasted salted peanuts with skins consumed daily
• Другое Isocaloric food
  Corn chips (45g)

Первичные конечные точки

• Change in psychosocial stress over time [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of allostatic load following dietary interventions [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of monocyte gene expression [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of cytokine and interferon production in PBMCs [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of cytotoxicity of peripheral natural killer cells [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of interferon-gamma [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of tumor necrosis factors alpha and beta [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of interleukins [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of fibroblast growth factor [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change from baseline of granulocyte-macrophage colony-stimulating factor [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]

Вторичные конечные точки (12)

• Changes in stool consistency [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in stool metrics [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in bowel movement frequency [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in Gastrointestinal (GI) symptoms [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in gut microbial diversity [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in stool short chain fatty acids [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Changes in gut inflammatory markers [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change in salivary cortisol [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change in urinary cortisol levels [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change in urinary epinephrine levels [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change in urinary norepinephrine levels [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]
• Change in urinary creatinine levels [Срок оценки: Baseline, 4 weeks, 8 weeks, and 12 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Открытое

Основная цель

Фундаментальное исследование

Центры проведения

США · 1 центр

• Western Human Nutrition Research Center — Davis

Идентификаторы

NCT: NCT07735221 · 2280324

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗