Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 24
- 试验地点
- 2
- 主要终点
- Changes in parameters of immune response
研究概览
简要总结
The aim of the present study is to determine the effect of Iso-alpha Acids and Xanthohumol from hops on the immune response in overweight participants.
详细描述
The aim of the present study is to investigate whether the oral intake of Xanthohumol and Iso-alpha Acids has different protective effects on the immune response of isolated blood cells from overweight people with people with incipient metabolic diseases, what the time course of the effect is and whether the levels of the substances differ from normal-weight individuals.
After taking a fasting blood sample, the study participants receive one of the study drinks and a light breakfast. Both should be consumed within 15 minutes. Further blood samples are taken 1, 2, 3, 4 and 6 hours after the drinks have been consumed. To assess the effect of Xanthohumol and Iso-alpha Acids or a combination of both, clinical parameters, blood lipids, blood glucose, uric acid and inflammatory markers will be determined. Furthermore, blood cells, isolated from blood samples of each time point, will be stimulated for measuring inflammatory markers.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BMI 25 - 29,9 kg/m²
- •as well as one or more of the following incipient metabolic diseases:
- •pre-diabetes (fasting blood glucose 100-125 mg/dL),
- •fatty liver (grade 1-3),
- •high-normal blood pressure to mild hypertension (grade 1, systolic 140-159 mmHg)
排除标准
- •History of diseases that could falsify the study results
- •inflammatory bowel diseases
- •malignant diseases of the gastrointestinal tract
- •food allergies
- •malabsorption
- •kidney or liver disease (except simple fatty liver)
- •symptomatic heart failure
- •Taking medication to treat these diseases
- •Consumption of special diets (e.g. vegan, gluten-free)
- •Pregnancy
结局指标
主要结局
Changes in parameters of immune response
时间窗: 6 hours
Changes in concentration of interleukin 6 (ng/ml) in cell culture supernatant of stimulated cells
次要结局
未报告次要终点
研究者
Prof. Dr. Ina Bergheim
Principal Investigator
University of Vienna
