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

NCT07497555 | Recruiting

• 1 other identifier: 25-FaSPyN-SA-02
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Overweight (BMI > 25)

Keywords

pecan nut oil; overweight; controlled trial; nutraceuticals; chronic low-grade inflammation

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and after 60 days after the start of intervention

Secondary Outcomes (12)

• Body weight (kg)

  Baseline and after 60 days of intervention

• Body mass index (BMI)

  Baseline and after 60 days of intervention

• Body fat (%)

  Baseline and after 60 days of intervention

• Waist circumference (cm)

  Baseline and after 60 days of intervention

• Hip circumference (cm)

  Baseline and after 60 days of intervention

Study Arms (2)

Pecan nut oil supplementation

EXPERIMENTAL

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

Control group

NO INTERVENTION

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.

Interventions

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.

Pecan nut oil supplementation

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad Autonoma de Nuevo Leon: lead
• Hospital Universitario Dr. Jose E. Gonzalez: collaborator
• Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco: collaborator

Study Sites (1)

Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León

Monterrey, Nuevo León, 64460, Mexico

RECRUITING

MeSH Terms

Conditions

Overweight

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor and Researcher, Facultad de Salud Publica y Nutricion

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: October 15, 2025
• Primary Completion: July 30, 2026
• Study Completion: July 30, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-02

Locations

ME (1)