To Collect Enriched Human Serum Following Hydrolyzed Collagen Intake

NCT07195396 | Completed

• 1 other identifier: BTS2215/25
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Women

Keywords

collagen peptides; collagen hydrolysates; enriched human serum

Outcome Measures

Primary Outcomes (1)

• collagen-derived di- and tripeptides

  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

  0-120 minutes

Secondary Outcomes (1)

• Amino acids profile

  0-120 minutes

Study Arms (5)

Collagen hydrolysate 1

ACTIVE COMPARATOR

10g single oral dose dissolved in water

Dietary Supplement: Collagen hydrolysate 1

Collagen hydrolysate 2

ACTIVE COMPARATOR

10g single oral dose dissolved in water

Dietary Supplement: Collagen hydrolysate 2

Collagen hydrolysate 3

ACTIVE COMPARATOR

10g single oral dose dissolved in water

Dietary Supplement: Collagen hydrolysate 3

Collagen hydrolysate 4

ACTIVE COMPARATOR

10g single oral dose dissolved in water

Dietary Supplement: Collagen hydrolysate 4

Collagen hydrolysate 5

ACTIVE COMPARATOR

10g single oral dose dissolved in water

Dietary Supplement: Collagen hydrolysate 5

Interventions

Collagen hydrolysate 2 DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Also known as: collagen peptides

Collagen hydrolysate 2

Collagen hydrolysate 3 DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Also known as: collagen peptides

Collagen hydrolysate 3

Collagen hydrolysate 4 DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Also known as: collagen peptides

Collagen hydrolysate 4

Collagen hydrolysate 5 DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Also known as: collagen peptides

Collagen hydrolysate 5

Collagen hydrolysate 1 DIETARY_SUPPLEMENT

10g single oral dose dissolved in water

Also known as: Collagen peptides

Collagen hydrolysate 1

Eligibility Criteria

• Age: 35 Years - 45 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rousselot BVBA: lead
• BioTeSys GmbH: collaborator

Study Sites (1)

BioTeSys GmbH

Esslingen am Neckar, 73728, Germany

Location

Study Officials

• Praneeth Reddy Kuninty, PhD

  Rousselot BV

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2025
• First Posted: September 26, 2025
• Study Start: October 22, 2025
• Primary Completion: December 22, 2025
• Study Completion: December 22, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)