Influence of a Food Supplement on the Gut Microbiome in Healthy Obese Women

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.

Study Overview

• Status: Completed
• Conditions: Overweight
• Intervention / Treatment: Dietary supplement: Strath® Kräuterhefe Original (liquid)

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

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Switzerland
  • Kanton Zurich
    • Winterthur, Kanton Zurich, Switzerland, 8400
      • Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 31 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; The study is one armed	Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantitative difference in microbiome composition.	BoosterShot shotgun sequencing analysis down to the species level and compared with internationally accepted data banks. Comparison before-after.	Six weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	Analysing the influence of the food additive on obesity parameters.	Three weeks

Collaborators and Investigators

• Sponsor: Bio-Strath AG
• Collaborators: Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH
• Investigators: Study Director: Peter W. Joller, PhD, Dr.Joller BioMedical Consulting

Study record dates

Study Major Dates

• Study Start (Actual): May 11, 2017
• Primary Completion (Actual): February 2, 2019
• Study Completion (Actual): November 15, 2019

Study Registration Dates

• First Submitted: July 11, 2017
• First Submitted That Met QC Criteria: July 19, 2017
• First Posted (Actual): July 21, 2017

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Microbiome; 16S rRNA; Strath Herbal Yeast Preparation
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Body Weight; Overweight
• Other Study ID Numbers: BS2016.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After study termination we decide if for publication other researchers will be involved

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No