Influence of the microalgae Chlorella sorokiniana on microbiome-host interactions in humans
Not Applicable
Recruiting
- Conditions
- Healthy participants
- Registration Number
- DRKS00033648
- Lead Sponsor
- Technische Universität München, ZIEL - Institute for Food and Health, Lehrstuhl für Ernährung und Immunologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 75
Inclusion Criteria
Written declaration of consent; omnivore, vegetarian, vegan diet
Exclusion Criteria
Missing informed consent; current participation in another intervention study; known allergies or intolerances to Chlorella sorokiniana, the tested foods, mold, brillant blue FCF (E 133) or riboflavin (E 101); pregnancy or breastfeeding; body mass index below 18.5 or above 30 kg/m^2; special diets (low-carb, high-fat, formula, protein-supplemented, etc.); antibiotic treatment in the 6 months prior to the start of the study; diverticulitis; inflammatory bowel disease (ulcerative colitis, Crohn's disease); use of anticoagulants; pacemaker patients
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The changes in the composition of the microbiota of the participants after consumption of foods containing Chlorella sorokiniana (intact or broken cell wall) are the primary endpoint of the study. To investigate this, stool samples are collected from the subjects throughout the study. This is done during the one-week wash-in phase, during the two-week intervention phase in which the bread rolls are consumed, and during the subsequent four-week follow-up phase. The stool samples are then examined using bacterial sequencing to assess any changes in the microbiota composition based on the sequencing results. The primary aim is to analyze the increase in bacterial diversity in the intestines of the participants after the consumption of foods enriched with Chlorella sorokiniana.
- Secondary Outcome Measures
Name Time Method As a secondary endpoint of this study, the influence of the study foods on the metabolite profile in the intestines and blood of the participants will be examined to identify metabolic changes. For this purpose, the stool samples collected at the end of each phase (wash-in, intervention, follow-up) are analyzed for various metabolites (short-chain fatty acids, bile acids) using mass spectrometry. In addition, a blood sample is taken at the end of each phase. These blood samples are also analyzed for metabolites.