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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUSDA, Western Human Nutrition Research Center

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 volunteers

Qualifiers

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

Design model

Crossover

Treatments tested in this trial

  • Peanuts, roasted, salted with skins

    Other intervention

    42g roasted salted peanuts with skins consumed daily

  • Isocaloric food

    Other intervention

    Corn chips (45g)

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Peanut Intervention followed by corn chips InterventionExperimental treatment 2 interventions
Group B: Corn chip Intervention followed by Peanut InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
2

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).

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
3

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
4

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks

Secondary outcomes

1

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
2

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
3

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks
4

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.

Time frame
Baseline, 4 weeks, 8 weeks, and 12 weeks

Other outcomes

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