Bioavailability of Different Collagen-based Treatments After Oral Intake

NCT05722158 | Completed

• 1 other identifier: Collagen_2022
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Volunteers

Keywords

collagen; bioavailability; peptides; blood; oral; ingestion; randomized; blinded

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

Study Arms (5)

Placebo

PLACEBO COMPARATOR

This group will be provided with a placebo solution for comparative purposes.

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.

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.

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.

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.

Dietary Supplement: Dietary supplementation with the collagen-based product CP4.

Interventions

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.

Collagen-based product CP1

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.

Placebo

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.

Collagen-based product CP2

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.

Collagen-based product CP3

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.

Collagen-based product CP4

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Bionos Biotech S.L.: lead

Study Sites (1)

Bionos Biotech S.L.

Valencia, Valencia, 46026, Spain

Location

MeSH Terms

Interventions

Dietary Supplements

Intervention Hierarchy (Ancestors)

Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David Pajuelo Gamez

  Hospital La Fe

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 18, 2023
• First Posted: February 10, 2023
• Study Start: August 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: January 5, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)