healthy volunteers
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Anthropometric examinations (height, weight, hip and waist circumference) using standard methods. Continuous monitoring of interstitial glucose concentrations by a flash-glucose monitoring system (Freesyle LIBRE, Abbott Diabetes Care). Composition of gut microbiota and their genetic potential by 16S and shotgun sequencing. | — |
Countries
Germany
Contacts
Max Rubner-Institut; Bundesforschungsinstitut für Ernährung und Lebensmittel