Effects of Peanuts on Immunity and Cardiometabolic Risk Factors
- Conditions
- Immune ResponseCardiometabolic Risk Factors
- Interventions
- Other: Peanut intake
- Registration Number
- NCT06159556
- Lead Sponsor
- Loma Linda University
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- adults between the ages of 18-70 years
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Peanut group Peanut intake Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks
- Primary Outcome Measures
Name Time Method Changes in Lymphocyte activity baseline to 12 weeks The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)
Changes in lymphocyte populations 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 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 cytokine production 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 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 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 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 baseline to 12 weeks Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method
Changes in body weight 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 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 Outcome Measures
Name Time Method changes in upper respiratory infection questionnaire score baseline to 12 weeks 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.
Trial Locations
- Locations (1)
Loma Linda University School of Public Health
🇺🇸Loma Linda, California, United States