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

NCT03223987 | Completed Phase 1

• 1 other identifier: BS2016.1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight

Keywords

16S rRNA; Microbiome; Strath Herbal Yeast Preparation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• BMI

  Three weeks

Study Arms (1)

1

EXPERIMENTAL

The study is one armed

Dietary Supplement: Strath® Kräuterhefe Original (liquid)

Interventions

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.

1

Eligibility Criteria

• Age: 25 Years - 35 Years
• Gender Eligibility Details: xx genome
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women, 25 to 35 years, BMI 30-35
• German speaking
• Smartphone owner

You may not qualify if:

• 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

Sponsors & Collaborators

• Bio-Strath AG: lead
• Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH: collaborator

Study Sites (1)

Center for Obesity and Metabolism Adimed - Zentrum für Adipositas- und Stoffwechselmedizin Winterthur GmbH Lagerhausstrasse 9

Winterthur, Canton of Zurich, 8400, Switzerland

Location

MeSH Terms

Conditions

Overweight

Interventions

Fluid Therapy

Condition Hierarchy (Ancestors)

Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Peter W. Joller, PhD

  Dr.Joller BioMedical Consulting

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: First letter of prename, second and third letter of name.
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Peter Joller, PhD Clinical Immunology FAMH

Model Details: Before-after intervention, open label study

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 21, 2017
• Study Start: May 11, 2017
• Primary Completion: February 2, 2019
• Study Completion: November 15, 2019
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

CH (1)