Metabolomics study for the identification of biomarkers of food intake
- Conditions
- healthy volunteers
- Registration Number
- DRKS00008787
- Lead Sponsor
- Max Rubner-InstitutBundesforschungsinstitut für Ernährung und Lebensmittel
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 10
Healthy women and men (18 – 40 years)
BMI 18.5 – 30 kg/m2
Non-smoking
Volunteers who gave their written informed consent to participate in the study
Volunteers with diseases affecting the nutrient absorption, digestive function, metabolism or excretion of nutrients
Smokers
Volunteers regularly taking and medication (except hormonal contraceptives)
Volunteers who took supplements in the past 4 weeks
Volunteers who took antibiotics in the past 6 months
Volunteers who donated blood in the past 3 months
Pregnant or lactating women
Volunteers with known allergies/intolerances to one of the tested foods or one of the ingredients of the formula diet
Volunteers who can be expected not to comply with the study protocol
Volunteers who are institutionalized due to an administrative order or court order
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Analysis of the metabolite profile in plasma and urine by LC-MS/MS, GCxGC-MS, and NMR before, and 1, 2, 4, 6, 12, 24, and 48h after a single ingestion of the test meal in comparison to the control meal (formula diet = reference meal)
- Secondary Outcome Measures
Name Time Method Anthropometric examinations (height, weight, hip and waist circumference) using standard methods.<br>Continuous monitoring of interstitial glucose concentrations by a flash-glucose monitoring system (Freesyle LIBRE, Abbott Diabetes Care).<br>Composition of gut microbiota and their genetic potential by 16S and shotgun sequencing.<br>