OverweightPhase 1/2NCT03223987
Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
A Phase 1/2 study testing Strath® Kräuterhefe Original (liquid) in people with Overweight, run by Bio-Strath AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overweight
- What is being tested?
- Strath® Kräuterhefe Original (liquid)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteSwitzerland
- Study dates
- 11 May 2017to 15 Nov 2019
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women, 25 to 35 years, BMI 30-35
- German speaking
- Smartphone owner
Who cannot join
- 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.),
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- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9
Winterthur, Canton of Zurich, 8400
About this study
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.
Read the 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
- Conditions
- Overweight
- Being tested
- Strath® Kräuterhefe Original (liquid)
- Keywords
- 16S rRNA, Microbiome, Strath Herbal Yeast Preparation
- Medical subject headings
- Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strath® Kräuterhefe Original (liquid)Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The study is one armed Receives: Dietary Supplement: Strath® Kräuterhefe Original (liquid) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative difference in microbiome composition.
BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.
Measured: Six weeks.
Secondary outcomes (1)
BMI
Analysing the influence of the food additive on obesity parameters.
Measured: Three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start11 May 2017
- Primary completion2 Feb 2019
- Study completion15 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Before-after intervention, open label study
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bio-Strath AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
- Responsible party
- Principal investigator, Peter Joller, PhD, Bio-Strath AG
- Investigators
- Peter W. Joller, PhD, Study director, Dr.Joller BioMedical Consulting
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03223987
- Sponsor's protocol ID
- BS2016.1
- Status last verified
- Aug 2024
- First submitted
- 11 Jul 2017
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After study termination we decide if for publication other researchers will be involved
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women
- ClinicalTrials.gov ID
- NCT03223987
- Acronym / sponsor ID
- BS2016.1
- Conditions
- Overweight
- Keywords
- 16S rRNA, Microbiome, Strath Herbal Yeast Preparation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Bio-Strath AGIndustry (pharma, biotech, devices)
- Collaborators
- Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
- Study start
- 11 May 2017 (actual)
- Primary completion
- 2 Feb 2019 (actual)
- Study completion
- 15 Nov 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Before-after intervention, open label study
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Dietary Supplement: Strath® Kräuterhefe Original (liquid)The study is one armed |
Who may qualify
- Ages
- 25 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Women, 25 to 35 years, BMI 30-35
- German speaking
- Smartphone owner
Key exclusion criteria (20 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strath® Kräuterhefe Original (liquid)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. | Dietary supplement | 1 |
Primary outcome
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.
1 secondary outcome
BMI
Time frame: Three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided. After study termination we decide if for publication other researchers will be involved
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter W. Joller, PhD study director
Dr.Joller BioMedical Consulting
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Strath® Kräuterhefe Original (liquid) in people with Overweight, run by Bio-Strath AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative difference in microbiome composition. (time frame: Six weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.