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

Официальное название

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

Обзор

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

Вмешательства

• Пищевая добавка 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

Первичные конечные точки

• Change in interleukin-6 (IL-6) levels [Срок оценки: Baseline and after 60 days of intervention]
• Change in tumor necrosis factor-alpha (TNF-α) levels [Срок оценки: Baseline and after 60 days of intervention.]
• Change in C-reactive protein (CRP) levels [Срок оценки: Baseline and after 60 days after the start of intervention]

Вторичные конечные точки (12)

• Body weight (kg) [Срок оценки: Baseline and after 60 days of intervention]
• Body mass index (BMI) [Срок оценки: Baseline and after 60 days of intervention]
• Body fat (%) [Срок оценки: Baseline and after 60 days of intervention]
• Waist circumference (cm) [Срок оценки: Baseline and after 60 days of intervention]
• Hip circumference (cm) [Срок оценки: Baseline and after 60 days of intervention]
• Change in fasting blood glucose [Срок оценки: Baseline and Day 60]
• Change in triglycerides (TG) [Срок оценки: Baseline and Day 60]
• Change in total cholesterol (TC) [Срок оценки: Baseline and Day 60]
• Change in high-density lipoprotein cholesterol (HDL-c) [Срок оценки: Baseline and Day 60]
• Change in low-density lipoprotein cholesterol (LDL-c) [Срок оценки: Baseline and Day 60]
• Change in daily energy intake [Срок оценки: Baseline and Day 60]
• Change in dietary intake assessed by 24-hour recall [Срок оценки: Baseline and Day 60]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Мексика · 1 центр

• Facultad de Salud Pública y Nutrición, Universidad Autónoma de Nuevo León — Monterrey

Идентификаторы

NCT: NCT07497555 · 25-FaSPyN-SA-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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