The Study on the Influence of Plantago Species (Plantago Major) on Adipose Tissue Content, Mineral Metabolism and Other Selected Biochemical Parameters of Blood in Obese Women
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- mineral content
研究概览
简要总结
Effect of oral supplementation with Plantago major on cardiometabolic risk factors and mineral content and lifestyle in obese women: double-blind, randomized clinical trial.
详细描述
The purpose of the study is to determine whether oral Plantago major supplementation affects cardiometabolic risk factors, mineral content, and lifestyle in obese women.
In previous research it was found that the Plantago maxima extract counteracts the development of adipose tissue in rats on a high-fat diet. In addition, antioxidative, anti-inflammatory and antidiabetic action of Plantago has been demonstrated. Moreover, it has been shown that Plantago influences lipolysis in obese mice and ameliorates metabolic processess in obese rats.
The project is due to evaluate the effect of oral supplementation with selected Plantago species - Plantago major in obese patients on:
- the content of minerals in blood, hair and urine
- total cholesterol, HDL and LDL cholesterol and triglycerides blood concentration,
- blood glucose and insulin concentration,
- blood pressure,
- anthropometric parameters: body mass, body height, waist and hip circumferences
- body content measured by bioimpedance: % of fat tissue and % of muscle tissue
- quality of life
70 subjects will be randomized into two groups and receive oral Plantago major extract (the first group) or oral placebo (the second group) once daily for 12 weeks. At baseline and at completion (after 12 weeks) fasting blood, urine and hair samples will be collected and abovementioned parameters will be measured.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •body mass index (BMI) equal to or greater than 30 kg/m2
- •age 18 to 60 years
- •stable body weight (< 3 kg self-reported change during the previous three months)
- •written informed consent to participate in the study,
- •abdominal obesity - waist circumference> 80 cm;
- •body fat content measured by bio-impedance ≥ 33%;
排除标准
- •secondary obesity or secondary hypertension
- •diabetes type I
- •gastrointestinal disease;
- •dyslipidaemia, type 2 diabetes, hypertension requiring the implementation of pharmacological treatment in the last 3 months prior to observation or follow-up;
- •a history of use of any dietary supplements within the one month prior to the study
- •clinically significant acute or chronic inflammatory disease in the respiratory, gastrointestinal or genitourinary system or in the mouth, throat, paranasal sinuses and / or connective tissue disease, arthritis;
- •simultaneous participation in a study that affects body mass or use of diet / medication / nutritional behaviors affecting body mass;
- •a history of infection in the month prior to the study
- •nicotine, drug or alcohol abuse
- •or other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit, or confound the study results
结局指标
主要结局
mineral content
时间窗: At the baseline and following 12 weeks of treatment
content of minerals in serum, urine and hair
次要结局
- blood pressure(At the baseline and following 12 weeks of treatment)
- body mass(At the baseline and following 12 weeks of treatment)
- waist circumference(At the baseline and following 12 weeks of treatment)
- body content measured by bioimpedance: % of muscle tissue(At the baseline and following 12 weeks of treatment)
- serum LDL cholesterol(At the baseline and following 12 weeks of treatment)
- body height(At the baseline and following 12 weeks of treatment)
- hip circumference(At the baseline and following 12 weeks of treatment)
- insulin(At the baseline and following 12 weeks of treatment)
- body content measured by bioimpedance: % of fat tissue(At the baseline and following 12 weeks of treatment)
- serum total cholesterol(At the baseline and following 12 weeks of treatment)
- serum HDL cholesterol(At the baseline and following 12 weeks of treatment)
- glucose(At the baseline and following 12 weeks of treatment)
- serum triglycerides(At the baseline and following 12 weeks of treatment)
研究者
Joanna Suliburska
assiastant professor
Poznan University of Life Sciences