Healthy Women
Conditions
Keywords
collagen peptides, collagen hydrolysates, enriched human serum
Brief summary
This randomized, double-blind, monocentric, five-way cross-over study aims to collect human serum and plasma samples at 1 and 2 hours after ingestion of hydrolyzed collagen peptides. The enriched sera will be used for ex vivo/ in vitro experiments on skin keratinocytes, fibroblasts, and other cell types to explore the beneficial effects of bioactive collagen peptides. Blood will also be analyzed for amino acid profiles and collagen-derived peptides.
Interventions
DIETARY_SUPPLEMENTCollagen hydrolysate 1
10g single oral dose dissolved in water
DIETARY_SUPPLEMENTCollagen hydrolysate 2
10g single oral dose dissolved in water
DIETARY_SUPPLEMENTCollagen hydrolysate 3
10g single oral dose dissolved in water
DIETARY_SUPPLEMENTCollagen hydrolysate 4
10g single oral dose dissolved in water
DIETARY_SUPPLEMENTCollagen hydrolysate 5
10g single oral dose dissolved in water
Sponsors
Rousselot BVBA
BioTeSys GmbH
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
35 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
* Participant is able and willing to sign the Informed Consent Form prior to screening evaluations * Age: 35 - 45 years * Women * BMI: 19 - 25 kg/m2 * Non-smoker * Participant is in good physical and mental health as established by medical history, physical examination, electrocardiogram, vital signs, results of biochemistry and haematology at screening
Exclusion criteria
* 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, significant CVD events, acute cancers within last 3 years except basal cell carcinoma of the skin, etc.) * 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 2 weeks) * Blood donation within 1 month prior to study start or during study * Low haemoglobin levels \< 12 g/dL * Regular intake of drugs or supplements possibly interfering with this study within 2 weeks prior to study start or during study (stable medication since \> 3 months e.g. L-Thyroxin, blood pressure medication etc. allowed) * Chronic intake of substances affecting blood coagulation (e.g. acetylic acid, anticoagulants (e.g. Marcumar), diuretics, thiazides), which in the investigator's opinion would impact participant safety * Not willing to avoid intake of pain relievers e.g. Paracetamol or Ibuprofen 24h prior to study days * Participants with history of drug, alcohol or other substance abuse, or other factors limiting their ability to co-operate during the study * History of hypersensitivity to fish * HIV-infection, acute or chronic hepatitis B and C infection * Known pregnancy, breast feeding or intention to become pregnant during the study. A pregnancy test will be conducted during screening and visits 1-5. * 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 * Participants considered inappropriate for the study by investigators, including participants who are unable or unwilling to show compliance with the protocol
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collagen-derived di- and tripeptides | 0-120 minutes | Change from baseline in serum concentration of collagen-derived di- and tripeptides (e.g., Pro-Hyp, Hyp-Gly in nanogram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Amino acids profile | 0-120 minutes | Change from baseline in plasma amino acid profile (e.g., hydroxyproline, proline, glycine in microgram/mL) at 1 hour and 2 hours post-intake, measured by LC-MS/MS |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORPraneeth Reddy Kuninty, PhD
Rousselot BV
Outcome results
None listed