Evaluation of a New Orange-Based Beverage Enriched With Polyphenols (Whole Press) on Features of Metabolic Syndrome and Cardiovascular Risk Factors Related to Inflammation and Antioxidant Defense System in Adult Humans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Systolic blood pressure
研究概览
简要总结
The purpose of this study is to evaluate the effects of a new orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones) on features of metabolic syndrome and cardiovascular disease risk factors related to inflammation and antioxidant defense system in overweight and obese adult humans. This study hypothesizes that consumption of an orange juice-based beverage enriched in fiber and selected phenolic compounds (mainly flavanones)would improve lipid levels and lipid metabolism,blood pressure and the Homeostatic Model Assessment (HOMA) index.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index (BMI) higher than 25 (overweight or obese) but lower than 40 (extreme obesity) or waist circumference higher than 94 cm for men and 80 cm for women,
- •and having altered at least two markers of MS namely:
- •Hypertension (diastolic pressure higher than 85 mmHg but lower than 110 mmHg)
- •Hyperglycemia (higher than 100 mg/dl but lower than 130 mg/dl)
- •Elevated plasma triacylglycerol concentrations (higher than 150 mg/dl)
- •Decreased plasma HDL-c levels (lower than 40 for men and 50 for women)
- •Volunteers will be otherwise healthy and without taking any medication aiming to lower either blood lipids, blood pressure or blood glucose concentrations.
排除标准
- •The presence of morbid obesity
- •Blood pressure higher than 110 mmHg
- •Plasma glucose levels higher than 130 mg/dl
- •The use of any medication for the control of blood pressure or glucose or lipid metabolism
- •Medical history of consumption of hypocaloric diet in the last year
- •Disorders of the food conduct
- •The presence of familiar dislipemias relatives of genetic character or the denial to take part in the study.
结局指标
主要结局
Systolic blood pressure
时间窗: 3 months
Fasting Plasma Insulin Concentration
时间窗: 3 months
Fasting Plasma Triacylglycerols Concentration
时间窗: 3 months
Fasting Plasma High-Density Lipoprotein Cholesterol Concentration
时间窗: 3 months
Insulin resistance using HOMA (Homeostatic Model Assessment)index
时间窗: 3 months
The HOMA index will be calculated as the product of the fasting plasma insulin level (mU/mL) and the fasting plasma glucose level (mmol/L), divided by 22.5
Fasting Plasma glucose concentrations
时间窗: 3 months
Diastolic blood pressure
时间窗: 3 months
次要结局
- Antioxidant defense system(3 months)
- Biomarkers of inflammation(3 months)
- Biomarkers of cardiovascular risk.(3 months)
- Metabolic analysis(3 months)
- Gene expression analysis(3 months)
研究者
Concepcion Aguilera
Lecturer of Biochemistry and Molecular Biology
Universidad de Granada