Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

Immune Response Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06159556
• Other study ID #: 5230190
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2024
• Est. completion date: December 20, 2024

Study information

• Verified date: June 2024
• Source: Loma Linda University
• Contact: Amandeep Wright, MPH
• Phone: 909-558-4300
• Email: amawright[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: December 20, 2024
• Est. primary completion date: December 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiometabolic Risk Factors
• Immune Response

Intervention

Other:
• Peanut intake
Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks

Locations

Country	Name	City	State
United States	Loma Linda University School of Public Health	Loma Linda	California

Sponsors (2)

Lead Sponsor	Collaborator
Loma Linda University	California Walnut Commission

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline to 12 weeks
Primary	Changes in Lymphocyte activity	The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Primary	Changes in cytokine production	The cytokines produced due to lymphocyte activity will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)	baseline to 12 weeks
Primary	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-?, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3	baseline to 12 weeks
Primary	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	baseline to 12 weeks
Primary	Changes in insulin resistance	Change in insulin resistance will be measured using the Hemostatic Model Assessment calculator version 2 (HOMA2-IR)	baseline to 12 weeks
Primary	Changes in Hemoglobin A1c	Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method	baseline to 12 weeks
Primary	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	baseline to 12 weeks
Primary	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.	baseline to 12 weeks
Primary	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	baseline to 12 weeks
Secondary	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.	baseline to 12 weeks