Healthy Volunteers Clinical Trial
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.
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. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05029518 -
3-Way Crossover Study to Compare the PK (Pharmokinetics) and to Evaluate the Effect of Food on the Bioavailability
|
Phase 1 | |
| Completed |
NCT05001152 -
Taste Assessment of Ozanimod
|
Phase 1 | |
| Completed |
NCT04493255 -
A Study to Determine the Metabolism and Elimination of [14C]E7090 in Healthy Male Participants
|
Phase 1 | |
| Completed |
NCT03457649 -
IV Dose Study to Assess the Safety, Tolerability, PK, PD and Immunogenicity of ARGX-113 in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT00995891 -
Collection of Blood, Bone Marrow, and Buccal Mucosa Samples From Healthy Volunteers for Center for Human Immunology, Autoimmunity, and Inflammatory Diseases (CHI) Laboratory Research Studies
|
||
| Completed |
NCT05043766 -
Evaluation of Oral PF614 Relative to OxyContin
|
Phase 1 | |
| Completed |
NCT05050318 -
Annual Study for Collection of Serum Samples in Children and Older Adults Receiving the 2021-2022 Formulations of Fluzone Quadrivalent Vaccine and Fluzone High-Dose Quadrivalent Vaccine, Respectively
|
Phase 4 | |
| Completed |
NCT04466748 -
A Multiple Ascending Dose Pharmacology Study of Anaprazole in Healthy Chinese Subjects
|
Phase 1 | |
| Completed |
NCT00746733 -
Vyvanse and Adderall XR Given Alone and in Combination With Prilosec OTC
|
Phase 1 | |
| Recruiting |
NCT05929651 -
Study of Immunogenicity and Safety of MenQuadfi® as a Booster Vaccine in Toddlers 12 to 23 Months, Regardless of the Quadrivalent Meningococcal Conjugate Vaccine Used for Priming in Infancy
|
Phase 4 | |
| Completed |
NCT05954039 -
Evaluation of the Efficacy of a Dietary Supplement on Hair Loss and Hair Aspect
|
N/A | |
| Completed |
NCT05045716 -
A Study of Subcutaneous Lecanemab in Healthy Participants
|
Phase 1 | |
| Active, not recruiting |
NCT02747927 -
Efficacy, Safety and Immunogenicity of Takeda's Tetravalent Dengue Vaccine (TDV) in Healthy Children
|
Phase 3 | |
| Completed |
NCT05533801 -
A Study to Demonstrate the Bioequivalence of Lecanemab Supplied in Vials and a Single-Use Auto-Injector (AI) in Healthy Participants
|
Phase 1 | |
| Not yet recruiting |
NCT03931369 -
Adaptation of Thirst to a Single Administration of Tolvaptan (TOLVATHIRST)
|
Phase 2 | |
| Completed |
NCT03279146 -
A Single Dose Study Evaluating PK of TXL Oral Formulations in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT06027437 -
A Study to Assess the Relative Biological Availability and the Effect of Food on the Drug Levels of Danicamtiv in Healthy Adult Participants
|
Phase 1 | |
| Recruiting |
NCT05619874 -
Effects of Two Virtual HIFCT Programs in Adults With Abdominal Obesity
|
N/A | |
| Completed |
NCT05553418 -
Investigational On-body Injector Clinical Study
|
N/A | |
| Completed |
NCT04092712 -
Study Evaluating Pharmacokinetics and Mass Balance of [14C]-CTP-543 in Healthy Adult Male Volunteers
|
Phase 1 |