Effects of Peanuts on Immunity and Cardiometabolic Risk Factors

NCT06159556 | Completed

• 1 other identifier: 5230190
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Response; Cardiometabolic Risk Factors

Keywords

Peanuts; Immunity; heart disease

Outcome Measures

Primary Outcomes (10)

• 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

• Changes in Lymphocyte activity

  The production of lymphocytes will be measured in the supernatant using enzyme linked immunosorbent assay (ELISA)

  baseline to 12 weeks

• 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

• 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-γ, MCP1, Eotaxin, E-selectin, RANTES and Pentraxin-3

  baseline to 12 weeks

• 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

• 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

• Changes in Hemoglobin A1c

  Change in Hemoglobin A1c will be measured by cation-exchange high-performance liquid chromatography method

  baseline to 12 weeks

• 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

• 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

• 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 Outcomes (1)

• changes in upper respiratory infection questionnaire score

  baseline to 12 weeks

Study Arms (2)

Peanut group

ACTIVE COMPARATOR

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

Other: Peanut intake

control group

NO INTERVENTION

Participants will continue with habitual diet and abstain from eating peanuts

Interventions

Peanut intake OTHER

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

Peanut group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adults between the ages of 18-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Loma Linda University: lead
• California Walnut Commission: collaborator

Study Sites (1)

Loma Linda University School of Public Health

Loma Linda, California, 92350, United States

Location

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: The proposed study is a 12 week parallel- group , free living, observer-blind randomized controlled study with 80 adult men and women

Study Record Dates

• First Submitted: November 28, 2023
• First Posted: December 6, 2023
• Study Start: January 31, 2024
• Primary Completion: September 26, 2024
• Study Completion: September 26, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)