Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Quantitative difference in microbiome composition.
Study Overview
Brief Summary
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.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Basic Science
- Masking
- None
Masking Description
First letter of prename, second and third letter of name.
Eligibility Criteria
- Ages
- 25 Years to 35 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Women, 25 to 35 years, BMI 30-35
- •German speaking
- •Smartphone owner
Exclusion Criteria
- •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
Arms & Interventions
1
The study is one armed
Intervention: Strath® Kräuterhefe Original (liquid) (Dietary Supplement)
Outcomes
Primary Outcomes
Quantitative difference in microbiome composition.
Time Frame: Six weeks.
BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.
Secondary Outcomes
- BMI(Three weeks)
Investigators
Peter Joller, PhD
Peter Joller, PhD Clinical Immunology FAMH
Bio-Strath AG