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Recruiting NCT07497555

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

No phase Interventional Overweight (BMI > 25)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pecan nut oil supplementation.
Who it may be relevant to
Registry conditions: Overweight (BMI > 25). Basic parameters: 18 years — 55 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Mexico
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

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

Interventions

  • Dietary supplement Pecan nut oil supplementation
    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 char

Primary outcome measures

  • Change in interleukin-6 (IL-6) levels [Time frame: Baseline and after 60 days of intervention]
  • Change in tumor necrosis factor-alpha (TNF-α) levels [Time frame: Baseline and after 60 days of intervention.]
  • Change in C-reactive protein (CRP) levels [Time frame: Baseline and after 60 days after the start of intervention]
Secondary outcome measures (12)
  • Body weight (kg) [Time frame: Baseline and after 60 days of intervention]
  • Body mass index (BMI) [Time frame: Baseline and after 60 days of intervention]
  • Body fat (%) [Time frame: Baseline and after 60 days of intervention]
  • Waist circumference (cm) [Time frame: Baseline and after 60 days of intervention]
  • Hip circumference (cm) [Time frame: Baseline and after 60 days of intervention]
  • Change in fasting blood glucose [Time frame: Baseline and Day 60]
  • Change in triglycerides (TG) [Time frame: Baseline and Day 60]
  • Change in total cholesterol (TC) [Time frame: Baseline and Day 60]
  • Change in high-density lipoprotein cholesterol (HDL-c) [Time frame: Baseline and Day 60]
  • Change in low-density lipoprotein cholesterol (LDL-c) [Time frame: Baseline and Day 60]
  • Change in daily energy intake [Time frame: Baseline and Day 60]
  • Change in dietary intake assessed by 24-hour recall [Time frame: Baseline and Day 60]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Mexico · 1 center
  • Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León — Monterrey

Identifiers

NCT: NCT07497555 · 25-FaSPyN-SA-02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗