Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07497555

Anti-Inflammatory Effects of Pecan Nut Oil Supplementation in Adults With Overweight: A 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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Overweight (BMI > 25) Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Monterrey, Nuevo León, 64460, Mexico

Location status: Recruiting

Location contact

Aurora Stephanie Hilario-Azuara, QFBT

CONTACT

[email protected]

+528146308248

Heriberto Castro García, PhD

CONTACT

[email protected]

+52 8113404890 ext. 3081

Heriberto Castro García, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

Sponsors and collaborators

Lead sponsor

Universidad Autonoma de Nuevo Leon

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.