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

Overweight Clinical Trial

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

Status Recruiting

Clinical 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. 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Overweight

• NCT number: NCT03223987
• Study type: Interventional
• Source: Bio-Strath AG
• Contact: Peter W. Joller, PhD
• Phone: +41443617353
• Email: medsciences@gmx.net
• Status: Recruiting
• Phase: Early Phase 1
• Start date: May 11, 2017
• Completion date: August 15, 2019