Clinical trial NCT06159556: Effects of Peanuts on Immunity and Cardiometabolic Risk Factors
Official title: Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Immune Response
Cardiometabolic Risk Factors
Keywords: Peanuts
Immunity
heart disease
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: California Walnut Commission
First posted: 2023-12-06
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
Primary purpose: PREVENTION

Brief summary: The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors.

Detailed description: The aim of the proposed study is two-fold: to determine whether the intake of peanuts (a) enhances immune function and (b) produces a desirable impact on selected cardiometabolic biomarkers and risk factors . To accomplish this objective, a human dietary intervention trial (RCT) with peanuts is proposed. The proposed study is a 12-week parallel-group, free-living, observer-blind, randomized controlled dietary intervention trial. This study will examine the effects of peanuts on markers of immune function, cardiometabolic markers and risk factors and upper respiratory tract infections, in 80 adult male and female volunteers.

Eligibility criteria: Inclusion Criteria:

* adults between the ages of 18-70 years

Exclusion Criteria:

* known intolerance or allergy to peanuts
* bad dentures unable to chew peanuts
* regular intake of peanuts and/or other nuts (\>3 ounces/week)
* use of immune-boosting supplements
* exposure to antibiotics and corticoids immediately prior to the study
* use of other medications or supplements that can interfere with the immune functions
* Individuals that received any vaccination (i.e flu or Covid 19) 6 months prior to the start of the study

Primary outcomes:
measure: Changes in lymphocyte populations
timeFrame: baseline to 12 weeks
measure: Changes in Lymphocyte activity
timeFrame: baseline to 12 weeks
measure: Changes in cytokine production
timeFrame: baseline to 12 weeks
measure: Changes in serum inflammatory cytokine concentration
timeFrame: baseline to 12 weeks
measure: Changes in the serum lipid concentration
timeFrame: baseline to 12 weeks
measure: Changes in insulin resistance
timeFrame: baseline to 12 weeks
measure: Changes in Hemoglobin A1c
timeFrame: baseline to 12 weeks
measure: Changes in body weight
timeFrame: baseline to 12 weeks
measure: changes in systolic and diastolic blood pressure
timeFrame: baseline to 12 weeks
measure: changes in percentage body fat
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: changes in upper respiratory infection questionnaire score
timeFrame: baseline to 12 weeks
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University School of Public Health
state: California
Study officials:
References: