Cardiometabolic Risk Factors, Immune Response
Conditions
Keywords
Peanuts, Immunity, heart disease
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.
Interventions
OTHERPeanut intake
Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks
Sponsors
California Walnut Commission
Loma Linda University
Study design
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.
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 Lymphocyte activity | baseline to 12 weeks | The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA) |
| 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 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 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed