About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Crossover
Treatments tested in this trial
Peanuts, roasted, salted with skins
Other intervention42g roasted salted peanuts with skins consumed daily
Isocaloric food
Other interventionCorn chips (45g)
Treatment groups
Trial outcomes
Primary outcomes
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.
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).
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.
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.
Secondary outcomes
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.
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.
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.
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.
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