Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
Primary Purpose
Overweight
Status
Unknown status
Phase
Early Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
Strath® Kräuterhefe Original (liquid)
Sponsored by
About this trial
This is an interventional basic science trial for Overweight focused on measuring 16S rRNA, Microbiome, Strath Herbal Yeast Preparation
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
Sites / Locations
- Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9Recruiting
Outcomes
Primary Outcome Measures
Quantitative difference in microbiome composition.
BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.
Secondary Outcome Measures
BMI
Analysing the influence of the food additive on obesity parameters.
Full Information
NCT ID
NCT03223987
First Posted
July 11, 2017
Last Updated
May 20, 2019
Sponsor
Bio-Strath AG
Collaborators
Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
1. Study Identification
Unique Protocol Identification Number
NCT03223987
Brief Title
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
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 11, 2017 (Actual)
Primary Completion Date
July 15, 2019 (Anticipated)
Study Completion Date
August 15, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Bio-Strath AG
Collaborators
Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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);
Does the participant have a particular or alternative lifestyle (e.g. vegan, vegetarian, only eating raw fruits and vegetables, etc.)?
- if yes → excluded
Does the participant control your nutrition in any form (food diary, app, counting calories, etc.)?
- if yes → excluded
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
Does the participant exercise regularly? If yes, how often? - if 3h/week or more → excluded
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
On how many days per week does the participant eat fish?
- if less or more than twice per week / 5 times per month → excluded
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
On how many days per week does the participant eat fruits or drink fruit juices approximately?
- if less than 5 days per week → excluded
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overweight
Keywords
16S rRNA, Microbiome, Strath Herbal Yeast Preparation
7. Study Design
Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
Before-after intervention, open label study
Masking
Care Provider
Masking Description
First letter of prename, second and third letter of name.
Allocation
Non-Randomized
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Dietary Supplement
Intervention Name(s)
Strath® Kräuterhefe Original (liquid)
Intervention Description
The food supplement is taken 3 x 1 coffee spoon à 5ml = 15ml per day for three weeks.
Stool analysis at 2nd visit and last visit. Before-after study.
Primary Outcome Measure Information:
Title
Quantitative difference in microbiome composition.
Description
BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.
Time Frame
Six weeks.
Secondary Outcome Measure Information:
Title
BMI
Description
Analysing the influence of the food additive on obesity parameters.
Time Frame
Three weeks
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
xy genome
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peter W. Joller, PhD
Phone
+41443617353
Email
medsciences@gmx.net
First Name & Middle Initial & Last Name or Official Title & Degree
Susanne Maurer, MD
Phone
+41522350502
Email
dr.smaurer-wiesner@hin.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter W. Joller, PhD
Organizational Affiliation
Dr.Joller BioMedical Consulting
Official's Role
Study Director
Facility Information:
Facility Name
Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9
City
Winterthur
State/Province
Kanton Zurich
ZIP/Postal Code
8400
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanne Maurer, MD
Phone
+41522350502
Email
dr.smaurer-wiesner@hin.ch
First Name & Middle Initial & Last Name & Degree
Annette Fehr
Phone
+41522350502
Email
Annette Fehr <a.fehr@adimed.ch>
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
After study termination we decide if for publication other researchers will be involved
Learn more about this trial
Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
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