Skip to main content
OpenTrials
Completed

NCT Number: NCT06159556

Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Immune Response Cardiometabolic Risk Factors Cardiovascular Diseases Heart Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Peanut intake

Other

Participants will consume 2 ounces of peanuts/peanut butter for 12 weeks

Primary outcomes

  1. 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

  2. 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)

  3. 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)

  4. 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

  5. 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

  6. 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)

  7. 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

  8. 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

  9. 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.

  10. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Collaborators

  • California Walnut Commission

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.