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

Universidad Autonoma de Nuevo Leon50 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Overweight (BMI > 25)

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in interleukin-6 (IL-6) levels

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.

Time frame: Baseline and after 60 days of intervention

Change in tumor necrosis factor-alpha (TNF-α) levels

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.

Time frame: Baseline and after 60 days of intervention.

Change in C-reactive protein (CRP) levels

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.

Time frame: Baseline and after 60 days after the start of intervention

Secondary Outcomes

Body weight (kg)

Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.

Time frame: Baseline and after 60 days of intervention

Body mass index (BMI)

Body mass index will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.

Time frame: Baseline and after 60 days of intervention

Body fat (%)

Body fat will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.

Time frame: Baseline and after 60 days of intervention

Waist circumference (cm)

Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.

Time frame: Baseline and after 60 days of intervention

Hip circumference (cm)

Hip circumference will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.

Time frame: Baseline and after 60 days of intervention

Change in fasting blood glucose

Difference in fasting blood glucose concentration between baseline (Day 0) and end of intervention (Day 60), measured in mg/dL.