A proof of concept study to evaluate the impact of a food supplement on production of short chain fatty acids and microbiome in healthy subjects
- Conditions
- healthy volunteers
- Registration Number
- DRKS00023166
- Lead Sponsor
- Evonik Operations GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Male
- Target Recruitment
- 18
Subject is in good physical and mental health as established by medical history, physical examination, vital signs, results of biochemistry, haematology,
Busy men with health unconscious eating patterns,
BMI: 19-30 kg/m²,
Non-smoker
• Relevant history or presence of any severe medical disorder, potentially interfering with this study
• Subject under prescription for medication for digestive symptoms such as anti-spasmodic, laxatives and anti-diarrheic drugs or other digestive auxiliaries, use of PPIs, bismuth salts and/or H2-antagonists
• Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery
• Vegetarians, vegans
• Subjects consuming food or drinks claimed as ‘probiotic’, or ‘prebiotic more than once weekly or food or drinks claimed as ‘rich in fiber’ (including specific milk products) more than 3 times per week ormore than 3 portions of fruits and vegetables (sum) per day
• Subjects with stool frequency of = 2 stools per week
• Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study.
• Relevant allergy or known hypersensitivity against compounds of the study preparations
• Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study
• Anticipating any planned changes in lifestyle or physical activity levels for the duration of the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Production of short chain fatty acids (SCFA) after 4 weeks
- Secondary Outcome Measures
Name Time Method Changes in microbiome after 4 week, Impact on stool consistency an frequency