Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Loma Linda University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Changes in lymphocyte populations
Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Investigator, Outcomes Assessor)
Masking Description
The investigator and outcome assessor will not be aware which participant is in what arm. The participant and the care provider will know about the treatment allocation.
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
Changes in lymphocyte populations
Time Frame: baseline to 12 weeks
Immunophenotyping will be performed by flow cytometry to measure the number of T helper, T cytotoxic, Naive and memory cells and B cells
Changes in serum inflammatory cytokine concentration
Time Frame: baseline to 12 weeks
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
Changes in Lymphocyte activity
Time Frame: baseline to 12 weeks
The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
Changes in cytokine production
Time Frame: baseline to 12 weeks
The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
changes in percentage body fat
Time Frame: baseline to 12 weeks
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
Changes in the serum lipid concentration
Time Frame: baseline to 12 weeks
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
Changes in insulin resistance
Time Frame: baseline to 12 weeks
Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)
Changes in Hemoglobin A1c
Time Frame: baseline to 12 weeks
Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
Changes in body weight
Time Frame: baseline to 12 weeks
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
changes in systolic and diastolic blood pressure
Time Frame: baseline to 12 weeks
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.
Secondary Outcomes
- changes in upper respiratory infection questionnaire score(baseline to 12 weeks)
Investigators
Joan Sabate,DrPH, MD
Professor
Loma Linda University