Effect of Common Bean Baked Snack (Phaseolus Vulgaris L.) Consumption on Blood Lipid Levels and Hormones Regulating Appetite and Satiety: Randomized Crossover Clinical Trials
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
研究概览
简要总结
Introduction: The Mexican population consumes vegetables and snacks with the same frequency. Besides, most of the snacks available on the market contain high fat, sodium and calorie, and low protein levels. Regular consumption of these snacks and low physical activity could promote the development of noncommunicable diseases. Common bean-based snacks are potential healthier alternatives to replace conventional snacks.
Hypothesis: The consumption of a common bean baked snack (Phaseolus vulgaris L.) reduces blood lipid levels in overweight people with altered blood lipid levels.
Objectives: Evaluate the effect of common bean baked snack consumption on blood lipid levels in overweight people with altered blood lipid levels.
Material and Methods: Randomized crossover clinical trial, 28 patients with altered blood lipid levels, 18-40 years old, snack supplementation for four weeks, clinical and laboratory determinations, such as total cholesterol, triglycerides, LDL, HDL, among others.
- Intervention phase: Common bean baked snack intervention.
- Control phase B: No intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI between 25.0 and 29.9 kg/m2,
- •Abnormal serum lipid levels:
- •Total cholesterol: ≥200 mg/dL,
- •Low-density lipoproteins: 100 to 190 mg/dL,
- •High-density lipoproteins: <50 mg/dL in females and <40 mg/dL in males,
- •Triglycerides: 150 to 500 mg/dL.
排除标准
- •Pregnancy or lactation,
- •Plans to lose or gain weight in the next three months,
- •Modification of diet or physical activity in the last three months,
- •Diagnosis of diabetes, cancer, hypertension, heart disease, gastrointestinal disorder, pancreatitis, kidney, liver or thyroid disease,
- •Smoking or drug use,
- •Sensitivity for bean consumption,
- •Pharmacological treatment or consumption of non-prescription drugs, herbal or nutritional supplements known to modify serum lipid levels.
结局指标
主要结局
Change from baseline in the mean low-density lipoprotein (mg/dL) at 28 days
时间窗: Baseline and 28 days
Change from baseline in the mean high-density lipoprotein (mg/dL) at 28 days
时间窗: Baseline and 28 days
Change from baseline in the mean total cholesterol (mg/dL) at 28 days
时间窗: Baseline and 28 days
Change from baseline in the mean triglycerides (mg/dL) at 28 days
时间窗: Baseline and 28 days
次要结局
未报告次要终点
研究者
Alejandro Escobedo Avila
Principal Investigator
Centro Universitario de Ciencias de la Salud, Mexico