Effects of a Chilean Diet Supplemented With Gevuina Avellana on Lipid Profile in Humans With Hypercholesterolemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- Total cholesterol (mg/dL)
研究概览
简要总结
The purpose of this study is to determine if supplementing a Chilean diet with Chilean hazelnut (Gevuina avellana) improves cholesterol levels in adults with hypercholesterolemia. The main question is whether this supplementation reduces total serum cholesterol compared to a low-fat diet without hazelnut.
详细描述
This is a 6-month randomized controlled parallel study involving hypercholesterolemic volunteers (serum cholesterol > 200 mg/dL, with or without triglycerides > 150 mg/dL) aged 18-60 years from Concepción, Chile. Participants are randomly assigned to two groups:
Intervention group: Receives the Chilean diet supplemented daily with 30 g of Chilean hazelnut (Gevuina avellana).
Control group: Receives dietary advice to follow a low-fat diet based on American Heart Association recommendations, without hazelnut supplementation.
Primary outcome is total serum cholesterol. Secondary assessments include anthropometric measures, blood pressure, diet adherence, physical activity, sociodemographic variables, smoking habits, medical diagnoses, medication use, and biochemical markers of lipid profile, oxidative damage, antioxidant capacity, endothelial peptides, and inflammation.
Data collection occurs at baseline, 2, 4, and 6 months. Individual motivational interviews and group motivational sessions (approximately 25 participants each) are conducted to enhance adherence. Blood samples for lipid profiling and other biochemical analyses are collected fasting at baseline and study completion.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum cholesterol level greater than 200 mg/dL with or without triacylglycerol greater than 150 mg/dL
- •Have received both doses included in the SARS-CoV-2 vaccination campaign and possess their corresponding mobility pass.
排除标准
- •Be undergoing medical treatment for hypercholesterolemia.
- •Have systemic diseases such as diabetes, hypertension, kidney, or liver disease.
- •Pregnant or breastfeeding women.
- •Have a household member or close relative who has been previously recruited.
- •Have allergies to tree nuts.
- •Have an electronic implant such as a pacemaker.
- •Also, individuals who do not meet the minimum conditions compatible with the study modality will not be able to participate in the intervention, such as: having access to an electronic device such as a cellphone or computer; having access to mobile internet or Wi-Fi at home; or having the necessary knowledge or support to use the platform
结局指标
主要结局
Total cholesterol (mg/dL)
时间窗: From enrollment to the end of treatment at 6 months
Total serum cholesterol under fasting condition
次要结局
- Blood pressure (mmHg)(From enrollment to the end of treatment at 6 months)
- Body weight (kg)(From enrollment to the end of treatment at 6 months)
- Height (m)(From enrollment to the end of treatment at 6 months)
- Body Mass Index (kg/m2)(From enrollment to the end of treatment at 6 months)
- Waist circumference (mm)(From enrollment to the end of treatment at 6 months)
- LDL cholesterol (mg/dL)(From enrollment to the end of treatment at 6 months)
- HDL cholesterol (mg/dL)(From enrollment to the end of treatment at 6 months)
- Triglycerides (mg/dL)(From enrollment to the end of treatment at 6 months)
- Superoxide dismutase activity(From enrollment to the end of treatment at 6 months)
- Catalase activity(From enrollment to the end of treatment at 6 months)
- Homocysteine(From enrollment to the end of treatment at 6 months)
- Adiponectin(From enrollment to the end of treatment at 6 months)
- Oxidized low-density lipoprotein (LDLox)(From enrollment to the end of treatment at 6 months)