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| Name | Class |
|---|---|
| Hospital Universitario Dr. Jose E. Gonzalez | OTHER |
| Centro de Investigación y Asistencia en Tecnología y Diseño del Estado de Jalisco | UNKNOWN |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight (kg) | Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation. | Baseline and after 60 days of intervention |
| Body mass index (BMI) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León | Recruiting | Monterrey | Nuevo León | 64460 | Mexico |
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Body mass index will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation.
| Baseline and after 60 days of intervention |
| Body fat (%) | Body fat will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation. | Baseline and after 60 days of intervention |
| Waist circumference (cm) | Body weight will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation. | Baseline and after 60 days of intervention |
| Hip circumference (cm) | Hip circumference will be measured at baseline and after 60 days of intervention to assess changes associated with pecan nut oil supplementation. | Baseline and after 60 days of intervention |
| Change in fasting blood glucose | Difference in fasting blood glucose concentration between baseline (Day 0) and end of intervention (Day 60), measured in mg/dL. | Baseline and Day 60 |
| Change in triglycerides (TG) | Difference in serum triglyceride levels between baseline (Day 0) and Day 60, measured in mg/dL. | Baseline and Day 60 |
| Change in total cholesterol (TC) | Difference in total cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. | Baseline and Day 60 |
| Change in high-density lipoprotein cholesterol (HDL-c) | Difference in HDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. | Baseline and Day 60 |
| Change in low-density lipoprotein cholesterol (LDL-c) | Difference in LDL cholesterol levels between baseline (Day 0) and Day 60, measured in mg/dL. | Baseline and Day 60 |
| Change in daily energy intake | Difference in daily energy intake between baseline (Day 0) and Day 60, estimated using 24-hour dietary recall, expressed in kcal/day. | Baseline and Day 60 |
| Change in dietary intake assessed by 24-hour recall | Changes in dietary intake patterns assessed using a 24-hour dietary recall at baseline (Day 0) and Day 60. | Baseline and Day 60 |
| ID | Term |
|---|---|
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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