Clinical trial NCT03223987: Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
Official title: Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Overweight
Keywords: 16S rRNA
Microbiome
Strath Herbal Yeast Preparation
Lead sponsor: Bio-Strath AG
Sponsor class: INDUSTRY
Collaborators: name: Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
First posted: 2017-07-21
Enrollment: 26
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Before-after intervention, open label study
Primary purpose: BASIC_SCIENCE

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)

Week 0: Intervention-Phase Implementation of food supplement Complete assessment Part III (see 8.2) Third check of inclusion/exclusion criteria

Week 3: Evaluation-Phase Complete assessment Part II, III and IV Fourth check of inclusion/exclusion criteria Compliance control

5.2 Methods of minimising bias (ICH/E6 6.4.3; AGEK 4.3; SPIRIT #16, 17) ICH: A description of the measures taken to minimize/avoid bias, including: Randomization, Blinding.

Homogenous sample selection. 5.2.1 Randomisation Not applicable

5.2.2 Blinding procedures Not applicable

5.2.3 Other methods of minimising bias The investigators are going to do a semi-quantitative screening to determine a participant's nutritional habits.

Questions about their nutritional habits asked in the screening (via questionnaire);

1. Does the participant have a particular or alternative lifestyle (e.g. vegan, vegetarian, only eating raw fruits and vegetables, etc.)?

   - if yes → excluded
2. Does the participant control your nutrition in any form (food diary, app, counting calories, etc.)?

   - if yes → excluded
3. Does the participant consciously eat food to strengthen your immune system or do you take additional supplements to influence your intestinal bacteria (e.g. pro- and/or prebiotic food like Actimel, Activia, etc.)?

   - if daily or weekly → excluded
4. Does the participant exercise regularly? If yes, how often? - if 3h/week or more → excluded
5. On how many days per week does the participant eat meat or meat products?

   - if less then twice and more than five times peer week → excluded
6. On how many days per week does the participant eat fish?

   - if less or more than twice per week / 5 times per month → excluded
7. On how many days per week does the participant eat salad, vegetables or vegetable juice (not counting potatoes)?

   - if less than 5 days per week → excluded
8. On how many days per week does the participant eat fruits or drink fruit juices approximately?

   - if less than 5 days per week → excluded
9. On how many days per week does the participant drink or eat milk or milk products approximately? - if less than 4 days per week → excluded

Eligibility criteria: 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

Primary outcomes:
measure: Quantitative difference in microbiome composition.
timeFrame: Six weeks.
Secondary outcomes:
measure: BMI
timeFrame: Three weeks
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9
state: Kanton Zurich
Study officials:
affiliation: Dr.Joller BioMedical Consulting
name: Peter W. Joller, PhD
role: STUDY_DIRECTOR
References: