Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

NCT ID: NCT06159556

Last Updated: 2024-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-01-31

Study Completion Date

2024-09-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Immune Response Cardiometabolic Risk Factors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Peanut group

Participants will be consuming 2 ounces of peanuts /peanut butter everyday for 12 weeks

Group Type ACTIVE_COMPARATOR

Peanut intake

Intervention Type OTHER

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

control group

Participants will continue with habitual diet and abstain from eating peanuts

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Peanut intake

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

California Walnut Commission

OTHER

Sponsor Role collaborator

Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Joan Sabate,DrPH, MD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Loma Linda University School of Public Health

Loma Linda, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

5230190

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Diets Enriched With Pecans
NCT04376632 COMPLETED NA