Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Quantitative difference in microbiome composition.
研究概览
简要总结
Before and after study in obese women 25-35 years old, BMI 30-35, taking Strath® Kräuterhefe Original (liquid), Herbal Yeast Food Supplement for three weeks. At the beginning and after three weeks of the study a stool sample is provided. These samples are analysed with 16S rRNA analysis down to species level.The results are interpreted with the PICRUSt classification and Alpha Diversity Analysis and compared to internationally accepted data bases.
详细描述
Intervention: Variation of the gut microbiome via intake of an herbal yeast preparation.
Participants: healthy obese women between 25 and 35 years. Intervention to be studied: Intake of Strath® Kräuterhefe Original (liquid), Herbal Yeast Food Supplement over 3 weeks, stool analysis.
Sequence and duration of all study periods: 7 weeks per proband.
Week -4 - -2: Pre-Phase Hand out study information First check of inclusion/exclusion criteria
Week -2: Initiation-Phase Signed "Informed Consent" Second check of inclusion/exclusion criteria Complete assessment Part I, II (see 8.2) Start assessment Part IV (see 8.2)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
First letter of prename, second and third letter of name.
入排标准
- 年龄范围
- 25 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women, 25 to 35 years, BMI 30-35
- •German speaking
- •Smartphone owner
排除标准
- •Contraindications to the class of drugs under study, e.g. known hypersensitivity or allergy to class of drugs or the investigational product,
- •Women who are pregnant or breast feeding,
- •Intention to become pregnant during the course of the study,
- •Lack of safe contraception, defined as: Female participants of childbearing potential, not using and not willing to continue using a medically reliable method of contraception for the entire study duration, such as oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices, or who are not using any other method considered sufficiently reliable by the investigator in individual cases.
- •Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
- •Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.),
- •Known or suspected non-compliance, drug or alcohol abuse,
- •Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
- •Participation in another study with investigational drug within the 30 days preceding and during the present study,
- •Enrolment of the investigator, his/her family members, employees and other dependent persons
- •any kind of nutritional intervention due to a disease in the past 6 months
- •any mean of weight reduction in the past 6 months
- •Severe health problems in the last 6 months
- •Chronic digestive system problems
- •Medication against constipation and diarrhea
- •Mental problems
- •Major surgery
- •Allergies or Atopy
- •Drug intolerance
- •Antibiotics within 12 months before study
研究组 & 干预措施
1
The study is one armed
干预措施: Strath® Kräuterhefe Original (liquid) (Dietary Supplement)
结局指标
主要结局
Quantitative difference in microbiome composition.
时间窗: Six weeks.
BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.
次要结局
- BMI(Three weeks)
研究者
Peter Joller, PhD
Peter Joller, PhD Clinical Immunology FAMH
Bio-Strath AG