Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT07497555

Recruiting nowNot applicableInterventional

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 55 Years

SexAll

Healthy volunteersAccepted

ConditionOverweight (BMI > 25)

Full registry criteria

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

Treatments and study arms

Pecan nut oil supplementation

Dietary Supplement

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.

Primary outcomes

Change in interleukin-6 (IL-6) levelsBaseline 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.

Change in tumor necrosis factor-alpha (TNF-α) levelsBaseline 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.

Change in C-reactive protein (CRP) levelsBaseline 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.

Study locations

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Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León🇲🇽 Monterrey, Nuevo León, Mexico

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Heriberto Castro García, PhDContact

Email · Call +52 8113404890

Aurora Stephanie Hilario-Azuara, QFBTContact

Email · Call +528146308248

Heriberto Castro García, PhDPrincipal Investigator