Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

September 30, 2024 updated by: Joan Sabate,DrPH, MD, Loma Linda University

Effect of Daily Consumption of Peanuts on Immune Function and Cardiometabolic Markers and Risk Factors in Free-living Individuals: A Randomized Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University School of Public Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Peanut group
Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks
Other: Peanut intake
Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks
No Intervention: control group
Participants will continue with habitual diet and abstain from eating peanuts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
baseline to 12 weeks
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)
baseline to 12 weeks
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)
baseline to 12 weeks
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
baseline to 12 weeks
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
baseline to 12 weeks
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)
baseline to 12 weeks
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
baseline to 12 weeks
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
baseline to 12 weeks
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
baseline to 12 weeks
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.
baseline to 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
changes in upper respiratory infection questionnaire score
Time Frame: 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.
baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Collaborators

California Walnut Commission

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 31, 2024

Primary Completion (Actual)

September 26, 2024

Study Completion (Actual)

September 26, 2024

Study Registration Dates

First Submitted

November 28, 2023

First Submitted That Met QC Criteria

November 28, 2023

First Posted (Actual)

December 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 2, 2024

Last Update Submitted That Met QC Criteria

September 30, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 5230190

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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