Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Randomized Controlled Parallel-Group Clinical Trial

March 23, 2026 updated by: Heriberto Castro Garcia, Universidad Autonoma de Nuevo Leon

Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A Non-Randomized Controlled Parallel-Group Clinical Trial

The goal of this clinical trial is to evaluate whether daily supplementation with cold-pressed pecan nut oil can reduce inflammation in adults with overweight. The main questions it aims to answer are:

Does pecan nut oil supplementation reduce inflammatory biomarkers, including C-reactive protein (CRP), interleukin-6 (IL-6), and tumor necrosis factor-alpha (TNF-α)? Does pecan nut oil supplementation improve biochemical parameters such as fasting blood glucose and lipid profile? Researchers will compare an experimental group receiving pecan nut oil to a control group with no intervention to determine its effect on inflammation and metabolic parameters.

Participants will:

Consume 30 g/day of cold-pressed pecan nut oil under fasting conditions for 8 weeks (experimental group) Maintain their usual diet and physical activity throughout the study Attend two evaluation visits (baseline and Day 60) for blood sample collection and anthropometric measurements Provide dietary information using a 24-hour dietary recall

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

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

  • Mexico
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64460
        • Recruiting
        • Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heriberto Castro García, PhD

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

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 to 65 years
  • Body mass index (BMI) ≥25 and <30 kg/m² (overweight)
  • Willingness to participate and provide written informed consent
  • Ability to comply with study procedures and attend scheduled visits
  • Stable dietary habits and physical activity levels during the study period

Exclusion Criteria:

  • Diagnosis of chronic diseases such as diabetes mellitus, cardiovascular disease, liver disease, renal disease, or autoimmune disorders
  • Use of anti-inflammatory medications, lipid-lowering drugs, or dietary supplements within the last 3 months
  • Smoking or excessive alcohol consumption
  • Pregnancy or lactation
  • Known allergy or intolerance to nuts or nut-derived products
  • Participation in another clinical trial within the last 3 months
  • Any condition that, in the investigator's opinion, may interfere with study participation or outcomes

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Pecan nut oil supplementation
Participants in the experimental group will receive daily supplementation with pecan nut oil. The oil will be administered orally in standardized dose of 30 mL/day for a period of 60 days. The intervention aims to evaluate the anti-inflammatory effects and impact on metabolic and biochemical parameters in adults with overweight.
Dietary supplement: Pecan nut oil supplementation

Pecan nut oil will be administered as a dietary supplement by oral intake in a standardized daily dose of 30 mL/day for 60 days. The oil will be obtained through cold pressing, ensuring minimal processing and preservation of its bioactive compounds, particularly unsaturated fatty acids and antioxidants constituents.

This intervention is distinguished from conventional dietary interventions by the use of a regionally sourced pecan nut oil with defined physicochemical and oxidative stability characteristics, allowing for controlled evaluation of its nutraceutical potencial. Unlike general dietary modifications, this study focuses on a single, standardized bioactive source to specifically assess its role in modulating inflammatory biomarkers and metabolic parameters in adults with overweight.
No Intervention: Control group
Participants in the control group will not receive any supplementation and will be intructed to maintain their usual diet and lifestyle throughout the study period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in interleukin-6 (IL-6) levels
Time Frame: Baseline and after 60 days of intervention
The primary outcome will be the change in serum interleukin-6 (IL-6) levels, measured at baseline and after the intervention period, to assess the anti-inflammatory effect of pecan nut oil suplemmentation in adults with overweight.
Baseline and after 60 days of intervention
Change in tumor necrosis factor-alpha (TNF-α) levels
Time Frame: Baseline and after 60 days of intervention.
Changes in serum tumor necrosis factor-alpha (TNF-α) levels will be evaluated at baseline and after the intervention period as a key inflammatory marker.
Baseline and after 60 days of intervention.
Change in C-reactive protein (CRP) levels
Time Frame: Baseline and after 60 days after the start of intervention
The primary outcome will be the change in serum C-reactive protein (CRP) levels, measured at baseline and after 60 days of intervention, to evaluate the anti-inflammatory effect of pecan nut oil supplementation in adults with overweight.
Baseline and after 60 days after the start of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Body weight (kg)
Time Frame: Baseline and after 60 days of intervention
Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Baseline and after 60 days of intervention
Body mass index (BMI)
Time Frame: Baseline and after 60 days of intervention
Body mass index will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Baseline and after 60 days of intervention
Body fat (%)
Time Frame: Baseline and after 60 days of intervention
Body fat will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Baseline and after 60 days of intervention
Waist circumference (cm)
Time Frame: Baseline and after 60 days of intervention
Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Baseline and after 60 days of intervention
Hip circumference (cm)
Time Frame: Baseline and after 60 days of intervention
Hip circumference will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
Baseline and after 60 days of intervention
Change in fasting blood glucose
Time Frame: Baseline and Day 60
Difference in fasting blood glucose concentration between baseline (Day 0) and end of intervention (Day 60), measured in mg/dL.
Baseline and Day 60
Change in triglycerides (TG)
Time Frame: Baseline and Day 60
Difference in serum triglyceride levels between baseline (Day 0) and Day 60, measured in mg/dL.
Baseline and Day 60
Change in total cholesterol (TC)
Time Frame: Baseline and Day 60
Difference in total cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Baseline and Day 60
Change in high-density lipoprotein cholesterol (HDL-c)
Time Frame: Baseline and Day 60
Difference in HDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Baseline and Day 60
Change in low-density lipoprotein cholesterol (LDL-c)
Time Frame: Baseline and Day 60
Difference in LDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL.
Baseline and Day 60
Change in daily energy intake
Time Frame: Baseline and Day 60
Difference in daily energy intake between baseline (Day 0) and Day 60, estimated using 24-hour dietary recall, expressed in kcal/day.
Baseline and Day 60
Change in dietary intake assessed by 24-hour recall
Time Frame: Baseline and Day 60
Changes in dietary intake patterns assessed using a 24-hour dietary recall at baseline (Day 0) and Day 60.
Baseline and Day 60

Collaborators and Investigators

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

Sponsor

Universidad Autonoma de Nuevo Leon

Collaborators

Hospital Universitario Dr. Jose E. Gonzalez
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco

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)

October 15, 2025

Primary Completion (Estimated)

July 30, 2026

Study Completion (Estimated)

July 30, 2026

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-FaSPyN-SA-02

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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