Healthy subjects
Conditions
Interventions
Group 1: 20 g protein hydrolysate with 7 peptides as single dose
Sponsors
BASF SE
Eligibility
Sex/Gender
All
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: Participants in this study are 10 healthy men and women between 18 and 50 years with a body mass index (BMI) between 19 and 30 kg/m², good physical and mental condition, evidenced by inconspicuous medical history: such as ECG, vital signs, results of biochemistry & hematology.
Exclusion criteria
Exclusion criteria: Smoker, vegan, vegetarian, or subjects with a coffee consumption >3 cups/day. 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.). A significant CVD event within last 3 mo. incl. myocardial infarction, stroke, congestive heart failure. Significant changes in lifestyle or medication (within last 3 mo.) or surgical intervention or surgical procedure such as bariatric surgery. Application of corticoids (intravenously, orally or intraarticularly) and other immune-suppressing drug (within last 3 mo.). For this study clinically relevant abnormal laboratory, ECG, vital signs or physical findings at screening. Blood donation within 1 month prior to study start or during study . “Extreme dietary regimes”: vegan lifestyle, weight loss diet with <1200 kcal/day for women and <1800 kcal for men. Regular intake of drugs or supplements possibly interfering with this study (e.g. omega-3, curcumin, protein shakes or bars etc.) within 2 weeks prior to study start or during study. Subjects with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study. Known HIV-infection. Known acute or chronic hepatitis B and C infection. Known pregnancy, breast feeding or intention to become pregnant during the study. Participation in another clinical study within the last 4 weeks and concurrent participation in another clinical study, anticipating any planned changes in lifestyle for the duration of the study. Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol, subjects not willing to sign the study consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Demonstrate absorption (blood) of specific peptides as part of the native protein hydrolysate consumed by healthy subjects. Measurement time points: 0h, 0.5h, 1h, 2h, 3h, 4h, 8h, 12h und 24h; Determination of absorption rate, time of maximum blood concentration (Tmax), 24 h AUC, half time, elimination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Determine 24 h urine appearance of peptides. Assess plasma cytokine association with blood peptides. | — |
Countries
Germany
Contacts
Public ContactChristiane Schön
BioTeSys GmbH
Outcome results
None listed