Effect of a food supplement with a T. serpylli extract to evaluate the impact on gut health, microbiome and metabolic properties: a randomized double blind placebo-controlled study with two dosages
- Conditions
- Healthy participants
- Registration Number
- DRKS00026074
- Lead Sponsor
- Finzelberg GmbH & Co. KG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 40
Healthy individuals with no clinically diagnosed gastrointestinal disorders
- Women and men with mild to moderate gastrointestinal complaints
- BMI: 25.0 - 35.0 kg / m2
- Frequency of stool: 2 - 5 stools per week
- non-smokers
- Relevant history or presence of any severe medical disorder, potentially interfering with this study (e.g. mal absorption, chronic gastro-intestinal diseases, heavy depression, diabetes, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.)
- Subject under prescription for medication or taking dietary supplements possibly interfering with this study (such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists, fibers etc.) within 2 weeks prior to study start or during the study
o Intake of antibiotics in the last month and laxatives in the last 2 weeks prior to study start
o Vegetarians, vegans
o Subjects consuming-food or drinks claimed as ‘probiotic’, or ‘prebiotic’ more than once weekly
-food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week
-more than 3 portions of fruits and vegetables (sum) per day
o Subjects with diarrhoeal stool type (Bristol scale type 7) = 1 per week
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in the following parameters in blood and faces between baseline and after 4-week intervention with the two doses compared with placebo:<br><br>o Gastrointestinal symptoms GSRS (Gastrointestinal Symptom Rating Scale) Questionnaire<br>o Gut microbiota: 16S-rRNA analysis<br>o Stool frequency<br>o Stool consistency with Bristol stool form scale<br>o Short chain fatty acids (SCFA)<br>o Alpha-1-antitrypsin<br>o Secretory IgA<br>o Inflammatory biomarkers: (e.g., hsCRP, cytokine panel)<br>o Lipid status, Fasting glucose, Insulin and HOMA Index<br>o I-FABP<br>o ox-LDL<br>
- Secondary Outcome Measures
Name Time Method Additional parameters:<br>o Quality of life (SF-12)<br>o BMIS (Brief Mood Introspection Scale)<br>o PSQ20 (Perceived Stress Questionnaire)<br>o Global assessment