Healthy VolunteersNCT05722158
Bioavailability of Different Collagen-based Treatments After Oral Intake
A study testing Dietary supplementation with the collagen-based product CP1., Dietary supplementation with the collagen-based product CP2. and Dietary supplementation with the collagen-based product CP3. in people with Healthy Volunteers, run by Bionos Biotech S.L. at 1 site in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- Dietary supplementation with the collagen-based product CP1., Dietary supplementation with the collagen-based product CP2. and Dietary supplementation with the collagen-based product CP3.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteSpain
- Study dates
- 1 Aug 2023to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- - 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.
Show all 15Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- Dietary supplementation with placebo., Dietary supplementation with the collagen-based product CP1., Dietary supplementation with the collagen-based product CP2., Dietary supplementation with the collagen-based product CP3., Dietary supplementation with the collagen-based product CP4.
- Keywords
- collagen, bioavailability, peptides, blood, oral, ingestion, randomized, blinded
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dietary supplementation with placebo.Dietary supplement
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.
Dietary supplementation with the collagen-based product CP1.Dietary supplement
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.
Dietary supplementation with the collagen-based product CP2.Dietary supplement
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.
Dietary supplementation with the collagen-based product CP3.Dietary supplement
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.
Dietary supplementation with the collagen-based product CP4.Dietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | This group will be provided with a placebo solution for comparative purposes. Receives: Dietary Supplement: Dietary supplementation with placebo. |
| Collagen-based product CP1 | Experimental | This group will be provided with a the collagen-based product CP1, which will be compared to the placebo group. Receives: Dietary Supplement: Dietary supplementation with the collagen-based product CP1. |
| Collagen-based product CP2 | Experimental | This group will be provided with a the collagen-based product CP2, which will be compared to the placebo group. Receives: Dietary Supplement: Dietary supplementation with the collagen-based product CP2. |
| Collagen-based product CP3 | Experimental | This group will be provided with a the collagen-based product CP3, which will be compared to the placebo group. Receives: Dietary Supplement: Dietary supplementation with the collagen-based product CP3. |
| Collagen-based product CP4 | Experimental | This group will be provided with a the collagen-based product CP4, which will be compared to the placebo group. Receives: Dietary Supplement: Dietary supplementation with the collagen-based product CP4. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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)
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2023
- Study start1 Aug 2023
- Primary completion30 Sep 2023
- Study completion30 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bionos Biotech S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, José Luis Mullor, Bionos Biotech S.L.
- Investigators
- David Pajuelo Gamez, Principal investigator, Hospital La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05722158
- Sponsor's protocol ID
- Collagen_2022
- Status last verified
- Dec 2025
- First submitted
- 18 Jan 2023
- Last updated
- 5 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05722158
- Acronym / sponsor ID
- Collagen_2022
- Conditions
- Healthy Volunteers
- Keywords
- collagen, bioavailability, peptides, blood, oral, ingestion, randomized, blinded
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bionos Biotech S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 10 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: Dietary supplementation with placebo.This group will be provided with a placebo solution for comparative purposes. |
| Collagen-based product CP1 | Experimental | Dietary Supplement: Dietary supplementation with the collagen-based product CP1.This group will be provided with a the collagen-based product CP1, which will be compared to the placebo group. |
| Collagen-based product CP2 | Experimental | Dietary Supplement: Dietary supplementation with the collagen-based product CP2.This group will be provided with a the collagen-based product CP2, which will be compared to the placebo group. |
| Collagen-based product CP3 | Experimental | Dietary Supplement: Dietary supplementation with the collagen-based product CP3.This group will be provided with a the collagen-based product CP3, which will be compared to the placebo group. |
| Collagen-based product CP4 | Experimental | Dietary Supplement: Dietary supplementation with the collagen-based product CP4.This group will be provided with a the collagen-based product CP4, which will be compared to the placebo group. |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (15 listed)
- - 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Dietary supplement | Placebo |
| 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. | Dietary supplement | Collagen-based product CP1 |
| 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. | Dietary supplement | Collagen-based product CP2 |
| 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. | Dietary supplement | Collagen-based product CP3 |
| 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. | Dietary supplement | Collagen-based product CP4 |
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Pajuelo Gamez principal investigator
Hospital La Fe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary supplementation with the collagen-based product CP1., Dietary supplementation with the collagen-based product CP2. and Dietary supplementation with the collagen-based product CP3. in people with Healthy Volunteers, run by Bionos Biotech S.L. at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.