Nutritional Intervention to Evaluate the Effectiveness of the Consumption of Dehydrated Olive Pulp in Reducing Total Cholesterol Levels in Subjects with Overweight-obesity and High Total Cholesterol Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- LDL cholesterol
研究概览
简要总结
The main objective of this nutritional intervention is to assess the efficacy of polyphenol-rich capsules on reducing metabolic syndrome traits, mainly cholesterol levels. For this purpose, a double blind, placebo controlled study of 12 weeks will be carried out.
The target population is women and men with overweight or obesity. Researchers will compare the experimental capsules with placebo capsules, but will be blinded during the intervention and results analyses. Only after analysing the parameters, the groups will be revealed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 25 and 35 Kg/m2
- •Total Cholesterol levels in peripheral blood above or equal to 200 mg/dL or LDL-cholesterol levels above or equal to 160 mg/dL.
- •Weight stability during the three months prior the start of the study (±5% of variation).
- •To be able to attend the visits and accomplish with all the indications of the research staff.
- •To have signed the written informed consent.
排除标准
- •Any alteration of the Gastrointestinal system, functional or structural (gastric ulcer, chronic inflammatory diseases, hernia, etc.)
- •Subjects having undergone any surgical operation in th egastrointestinal tract with permanent consequences (i.e. gastroduodenectomy).
- •Subjects following any pharmacological treatment affecting gastric homeostasis.
- •Suffer from any metabolic disease or cancer process.
- •Being allergic to any of the compounds contained in the study capsules.
- •Excessive alcohol ingestion (14 units/day for women, or 20 units/day for men).
- •Women lactating or during pregnancy.
- •Following any cholesterol-lowering treatment.
- •People with any mental impairment or whose compliance with the study protocol is at risk.
结局指标
主要结局
LDL cholesterol
时间窗: 12 weeks
Serum Calculated LDL Cholesterol levels
HDL cholesterol
时间窗: 12 weeks
Serum concentration of HDL cholesterol
Triglycerides
时间窗: 12 weeks
Serum Triglycerides levels
Total cholesterol
时间窗: 12 weeks
Serum concentration of Total Cholesterol
次要结局
- Weight(12 weeks)
- Fat mass(12 weeks)
- Hemoglobin(12 weeks)
- Physical Activity(12 weeks)
- Blood pressure(12 weeks)
- Dietary intake(12 weeks)
- Hematocrit(12 weeks)