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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
80
Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks
Loma Linda University School of Public Health
Loma Linda, California, United States
Changes in lymphocyte populations
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naive and memory cells and B cells
Time frame: baseline to 12 weeks
Changes in Lymphocyte activity
The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
Time frame: baseline to 12 weeks
Changes in cytokine production
The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
Time frame: baseline to 12 weeks
Changes in serum inflammatory cytokine concentration
changes in the concentrations of the inflammatory cytokines will be performed on serum using enzyme linked immunoassay (ELISA) will include hs-CRP, interleukin (IL)-1B, IL-6, TNF a, IL-10 and IFN-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3
Time frame: baseline to 12 weeks
Changes in the serum lipid concentration
This is a composite measurement which will measure the changes in the levels of serum low density cholesterol, high density cholesterol, non- high density cholesterol and triglycerides
Time frame: baseline to 12 weeks
Changes in insulin resistance
Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)
Time frame: baseline to 12 weeks
Changes in Hemoglobin A1c
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
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Time frame: baseline to 12 weeks
Changes in body weight
A change in body weight for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
Time frame: baseline to 12 weeks
changes in systolic and diastolic blood pressure
Seated systolic and diastolic blood pressure will be measured at baseline and end of intervention utilizing Omron -Model HEM-7471 C device. Three measurements will be taken after a five-minute rest period, 1 minute apart, and the last two recordings will be averaged for analysis.
Time frame: baseline to 12 weeks
changes in percentage body fat
A change in the percentage of body fat for both the peanut and control group will be measured using an In Body machine at the baseline and end of intervention
Time frame: baseline to 12 weeks
changes in upper respiratory infection questionnaire score
Upper respiratory tract infections will be tracked using the Jackson and Dowling questionnaire. The questionnaire will be completed daily by participants, either manually or electronically , throughout the 12-week study period. The scale for the questionnaire is from 0-42. The higher score means worse outcome.
Time frame: baseline to 12 weeks