Overweight (BMI > 25)
Conditions
Keywords
pecan nut oil, overweight, controlled trial, nutraceuticals, chronic low-grade inflammation
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
Interventions
DIETARY_SUPPLEMENTPecan 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 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.
Sponsors
Universidad Autonoma de Nuevo Leon
Hospital Universitario Dr. Jose E. Gonzalez
Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in interleukin-6 (IL-6) levels | 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. |
| Change in tumor necrosis factor-alpha (TNF-α) levels | 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. |
| Change in C-reactive protein (CRP) levels | 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
| Measure | Time frame | Description |
|---|---|---|
| Body weight (kg) | 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. |
| Body mass index (BMI) | 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. |
| Body fat (%) | 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. |
| Waist circumference (cm) | 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. |
| Hip circumference (cm) | 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. |
| Change in fasting blood glucose | Baseline and Day 60 | Difference in fasting blood glucose concentration between baseline (Day 0) and end of intervention (Day 60), measured in mg/dL. |
| Change in triglycerides (TG) | Baseline and Day 60 | Difference in serum triglyceride levels between baseline (Day 0) and Day 60, measured in mg/dL. |
| Change in total cholesterol (TC) | Baseline and Day 60 | Difference in total cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. |
| Change in high-density lipoprotein cholesterol (HDL-c) | Baseline and Day 60 | Difference in HDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. |
| Change in low-density lipoprotein cholesterol (LDL-c) | Baseline and Day 60 | Difference in LDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. |
| Change in daily energy intake | 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. |
| Change in dietary intake assessed by 24-hour recall | Baseline and Day 60 | Changes in dietary intake patterns assessed using a 24-hour dietary recall at baseline (Day 0) and Day 60. |
Countries
Mexico
Outcome results
None listed