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临床试验/NCT06745102
NCT06745102招募中不适用

Effect of Iso-alpha Acids and Xanthohumol on the Human Immune System in Overweight People With the Onset of Metabolic Diseases

University of Vienna2 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2024年2月1日最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Ina Bergheim

Principal Investigator

University of Vienna

研究点 (2)

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