Bioavailability of Different Collagen-based Treatments After Oral Intake

December 31, 2025 updated by: José Luis Mullor, Bionos Biotech S.L.

Determination of Bioavailability and Identification of Amino Acid Profile, di- and Tri-peptides in Blood After Oral Ingestion of Collagen Peptides: Randomized, Blinded and Placebo Controlled Clinical Study

The goal of this clinical trial is to investigate the postprandial absorption of collagen and elucidate the absorption rate and bioavailability after oral intake of collagen-based products. Participants will be asked to drink solutions containing the study products (one product per group, a total of four products), and blood samples will be obtained by digital puncture at different time points. Plasma will be collected and a set of collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS. Each product will be compared to the placebo group.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Collagen is characterized by its high content of glycine, proline and hydroxyproline, and it is found to exert beneficial effects on several health benefits. Recent evidence suggests that the consumption of amino acids and/or peptides abundantly present in collagen may have the capacity to influence the synthesis of new collagen in the body. Indeed, it has been found that collagen supplements improve skin moisture, elasticity, and hydration when orally administered. Additionally, collagen reduces the wrinkling and roughness of the skin, and existing studies have not found any side effects of its oral supplements. Thus, to exert any beneficial effects, it is essential that hydrolyzed collagen is optimally absorbed. This study aimed to investigate the postprandial absorption of collagen and elucidate the absorption rate and bioavailability after oral intake.

The study personnel will prepare the drinkable solutions containing the study products in a room accessible to site staff only. Drinkable solutions will be provided to subjects just before consumption. Product ingestion will be early in the morning after overnight fasting for 12 h. On the morning of the experiment, subjects will fast and each subject will take the products orally. Dosage (Quantity of product to consume orally): This is calculated depending on the body weight; 400 mg/kg of body weight with 20 w/v % water. Collagen products (fine powder) will be diluted in water prior consumption. Control group ingest approximately same amount of plain water. Participants cannot drink water within 4 hours before and after the product consumption.

The assessment of the bioavailability of the four collagen-based treatments (CP1, CP2, CP3, CP4) will be evaluated by quantifying 8 di/tri-peptides and the amino acid profile in the blood of 25 volunteers by LC-MS.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Spain
    • Valencia
      • Valencia, Valencia, Spain, 46026
        • Bionos Biotech S.L.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

25 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Healthy male volunteers to avoid any possible hormonal interference.
  • Between 25-45 years old (both included).
  • Body weight is 70 kg (60-80 kg (both included), the range depends on the body mass index (BMI). BMI in normal (healthy weight and overweight) range: 18.5 to 29.9 kg/m2. (Reference: WHO and CDC).
  • Co-operative and available during the study period.
  • Subjects with capacity to understand the purpose and protocol of the study and sign the Informed Consent.

Exclusion Criteria:

  • - Diagnosis of allergies to gelatin, red meat (Alpha Gal Syndrome) or fish.
  • Diagnosis of diseases about collagen metabolism such as Goodpasture syndrome, scleroderma, periarteritis nodosa or polyarteritis, dermatomyositis, and disseminated lupus erythematosus.
  • Diagnosis of following chronic Gastro-Intestinal Tract diseases blocking transfer of polypeptides from GIS to the blood such as: Peptic Ulcer, Duodenal Ulcer, Chronic Atrophic Gastritis, Helicobacter Pylori, Chronic Peptic Disorders, Chronic Acid Reflux = GER and GERD, Celiac Disease, Crohn's Disease, Irritable Bowel Syndrome, Lactose Intolerance, Diverticulitis, Diverticulosis.
  • Diagnosis of any diseases such as cardiovascular disease, chronic kidney disease (CKD), gastrointestinal disorder, endocrinological disorder, immunological disorder, metabolic disease.
  • Consume more than the recommended alcohol guidelines i.e. >21 alcohol units/week for males and >14 units/week for females (europa.eu).
  • Current smoking habit or history of smoking within the past 1 year.
  • History of depression, schizophrenia, alcoholism, drug addiction, or mental illness.
  • Current or previous intake of contraceptives, female hormones, obesity drugs, absorption inhibitors, antidepressants, or appetite suppressants.
  • History of asthma or autoimmune disease Use of oral hormone therapies ie. cortisone or steroids in the 6 months prior to initiation of the study.
  • Abnormal liver function or abnormal renal function.
  • Blood pressure >140/90 mmHg or hypertension with intake of a diuretic.
  • No participation to another clinical trial in the last 6 months.
  • No blood donation within a month.
  • Problems with overall findings in blood-test results as determined by a specialist.
  • Any condition judged by the investigator to be unsuitable for participation in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
This group will be provided with a placebo solution for comparative purposes.
Dietary supplement: Dietary supplementation with placebo.
Volunteers will be provided with the placebo. For each volunteer, a blood sample from digital puncture will be obtained, and collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS.
Experimental: Collagen-based product CP1
This group will be provided with a the collagen-based product CP1, which will be compared to the placebo group.
Dietary supplement: Dietary supplementation with the collagen-based product CP1.
Volunteers will be provided with the collagen-derived product CP1. For each volunteer, a blood sample from digital puncture will be obtained, and collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS.
Experimental: Collagen-based product CP2
This group will be provided with a the collagen-based product CP2, which will be compared to the placebo group.
Dietary supplement: Dietary supplementation with the collagen-based product CP2.
Volunteers will be provided with the collagen-derived product CP2. For each volunteer, a blood sample from digital puncture will be obtained, and collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS.
Experimental: Collagen-based product CP3
This group will be provided with a the collagen-based product CP3, which will be compared to the placebo group.
Dietary supplement: Dietary supplementation with the collagen-based product CP3.
Volunteers will be provided with the collagen-derived product CP3. For each volunteer, a blood sample from digital puncture will be obtained, and collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS.
Experimental: Collagen-based product CP4
This group will be provided with a the collagen-based product CP4, which will be compared to the placebo group.
Dietary supplement: Dietary supplementation with the collagen-based product CP4.
Volunteers will be provided with the collagen-derived product CP4. For each volunteer, a blood sample from digital puncture will be obtained, and collagen-derived amino acids, di-peptides and tri-peptides will be quantified by LC-MS.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Quantification of the change of the collagen-derived amino acids, di-peptides and tri-peptides levels in plasma at time 0 minutes (before consuming the product), and 15 minutes, 30 minutes, 120 minutes and 240 minutes after consuming the product.
Time Frame: Upon oral intake, blood samples will be obtained by digital puncture at each time point; Time 0 minutes (before consuming the product), and 15 minutes, 30 minutes, 120 minutes and 240 minutes after consuming the product.

Upon oral intake, blood samples will be obtained by digital puncture at time 0 minutes (before consuming the product), and 15 minutes, 30 minutes, 120 minutes and 240 minutes after consuming the product. The digital puncture will be performed with Verifine Safety Lancets, and the blood will be collected in MiniCollect tubes. Blood samples will be centrifuged (1000 rpm, 5 minutes, 4ºC) and plasma will be collected. The profile of single amino acids and selected di- and tripeptides will be determined in the plasma samples by mass spectrometry (LC-MS) and the change in the levels of these molecules will be assessed in the specified time points. The following molecules will be analyzed:

  • Single aminoacids (approx. 20 aminoacids, but especially hydroxyproline, glycine, proline)
  • Dipeptides (Pro-Hyp, Hyp-Gly, Ala-Hyp, Phe-Hyp)
  • Tripeptides (Gly-Pro-Hyp, Pro-Hyp-Gly, Ala-Hyp-Gly, Ser-Hyp-Gly)
Upon oral intake, blood samples will be obtained by digital puncture at each time point; Time 0 minutes (before consuming the product), and 15 minutes, 30 minutes, 120 minutes and 240 minutes after consuming the product.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Bionos Biotech S.L.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Pajuelo Gamez, Hospital la Fé

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 18, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 8, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 10, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Collagen_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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