About this 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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Pecan nut oil supplementation
Dietary supplementPecan 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.
Treatment groups
Trial 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.
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.
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.
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.
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.
Body fat (%)
Body fat will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
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.
Sponsors and contacts
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Universidad Autonoma de Nuevo Leon
Lead sponsor
Hospital Universitario Dr. Jose E. Gonzalez
Collaborator
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
Collaborator