Impact of Collagen Supplements on Dermal Collagen in Plastic and Bariatric Surgery Patients (COLLAGEN)

Effect of Collagen Supplements on Dermal Collagen Content Within Skin Biopsies of Plastic Surgery and Metabolic Bariatric Surgery Patients

This study aims to evaluate the effects of oral collagen supplementation on dermal collagen content in skin biopsies of patients undergoing abdominoplasty. Using a randomized controlled trial (RCT) design, participants from metabolic bariatric surgery (MBS) and plastic surgery groups will receive either collagen supplements or a placebo for several weeks. Biopsies will be collected pre-intervention and during surgery to compare collagen levels between groups and to baseline. The primary objective is to determine if collagen supplementation significantly enhances dermal collagen deposition compared to placebo and initial levels.

Study Overview

• Status: Completed
• Conditions: Randomized Controlled Trial; Abdominoplasty; Skin Physiology; Bariatric Surgery; Collagen Synthesis; Tissue Remodeling
• Intervention / Treatment: Dietary supplement: Starch; Dietary supplement: Collagen hydrolyzed peptides

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Alexandria, Egypt
    • Facility Name: The surgical department of Medical Research Institute Hospital, Alexandria University, Alexandria, Facility

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18-75 years after metabolic bariatric surgery.
• Patients will be randomly selected from the hospital's electronic patient system.

Exclusion Criteria:

• 1. Allergies or Sensitivities:

  • Patients with known allergies or hypersensitivity to collagen or any components of the collagen supplements (e.g., bovine, marine sources).

    2. Chronic Skin Conditions:

  • Participants with skin disorders that could influence collagen production or degradation (e.g., psoriasis, eczema, scleroderma) should be excluded as these conditions might interfere with the study's outcomes.

    3. Autoimmune or Connective Tissue Diseases:

  • Patients with autoimmune diseases (e.g., lupus, rheumatoid arthritis) or connective tissue disorders (e.g., Ehlers-Danlos syndrome) might exhibit abnormal collagen metabolism and could confound the study's results.

    4. Use of Collagen or Nutritional Supplements:

  • Participants currently taking collagen supplements or other nutritional supplements (e.g., vitamin C, glucosamine, chondroitin) that could affect collagen synthesis or turnover should be excluded. A washout period may be required for those who have recently used such supplements.

    5. Hormonal Treatments or Medications:

  • Patients on treatments that could affect collagen metabolism (e.g., corticosteroids, hormone replacement therapy, anabolic steroids) should be excluded, as these could alter the body's collagen production or degradation.

    6. Pregnancy or Lactation:

  • Pregnant or breastfeeding women should be excluded due to the physiological changes during pregnancy and lactation that could affect collagen metabolism.

    7. Major Surgeries or Trauma:

  • Recent major surgeries or significant trauma within the last 6-12 months, especially those involving connective tissue repair, as these could alter collagen levels independently of supplementation.

    8. Smoking:

  • Smokers or individuals who have recently quit smoking, as smoking is known to reduce collagen synthesis and impair skin healing.

    9. Chronic Illnesses:

  • Patients with chronic illnesses such as diabetes, liver disease, or kidney disease, which could impair collagen metabolism or affect skin health.

    10. Uncontrolled Metabolic Disorders:

  • Participants with uncontrolled metabolic disorders (e.g., severe obesity, untreated hyperlipidemia) may have altered collagen metabolism and should be excluded unless specifically studied.

    11. Participation in Other Clinical Trials:

  • Patients currently enrolled in other clinical trials involving supplements, medications, or procedures that could interfere with the study outcomes should be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Starch	Dietary supplement: Starch; Starch placebo
Experimental: Collagen; Collagen supplement	Dietary supplement: Collagen hydrolyzed peptides; bovine collagen peptides

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Wound Healing Parameters vascularity	Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 1. vascularity with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation	Biopsy during surgery
Assessment of Wound Healing Parameters pigmentation	Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 2. pigmentation, with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation	Biopsy during surgery
Assessment of Wound Healing Parameters thickness	Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 3. thickness, with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation	Biopsy during surgery
Assessment of Wound Healing Parameters pliability	Wound healing will be evaluated using the single Vancouver Scar Scale (VSS), a validated tool for assessing scar quality. The VSS includes 4. pliability with higher scores indicating more severe scar formation. This scale will allow for an objective evaluation of the appearance and functional quality of the wound healing in both the collagen supplement and placebo groups. The VSS has been widely used in clinical research for assessing scars in burn patients and offers a standardized approach to scar evaluation	Biopsy during surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Serum Parameters hydroxyproline	Total serum hydroxyproline, a marker of collagen degradation and turnover, will be measured in both the collagen supplement and placebo groups using the colorimetric method. This well-established technique provides accurate quantification of hydroxyproline levels, which will be used to infer collagen metabolism. Hydroxyproline levels will be compared between the groups using appropriate statistical tests to determine the impact of collagen supplementation on systemic collagen turnover. Potential confounding factors, such as dietary gelatin intake and conditions like hepatic fibrosis, which can influence hydroxyproline levels, will be carefully controlled for. These factors will be considered exclusion criteria to ensure the reliability of the serum hydroxyproline measurements	biopsy during surgery

Collaborators and Investigators

• Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
• Investigators: Principal Investigator: Mohamed Hany Ashour, professor, MD, Alexandria University

Publications and helpful links

General Publications

• Zague V, de Freitas V, da Costa Rosa M, de Castro GA, Jaeger RG, Machado-Santelli GM. Collagen hydrolysate intake increases skin collagen expression and suppresses matrix metalloproteinase 2 activity. J Med Food. 2011 Jun;14(6):618-24. doi: 10.1089/jmf.2010.0085. Epub 2011 Apr 11.
• Sanchez A, Blanco M, Correa B, Perez-Martin RI, Sotelo CG. Effect of Fish Collagen Hydrolysates on Type I Collagen mRNA Levels of Human Dermal Fibroblast Culture. Mar Drugs. 2018 Apr 26;16(5):144. doi: 10.3390/md16050144.
• Liu Z, Li Y, Song H, He J, Li G, Zheng Y, Li B. Collagen peptides promote photoaging skin cell repair by activating the TGF-beta/Smad pathway and depressing collagen degradation. Food Funct. 2019 Sep 1;10(9):6121-6134. doi: 10.1039/c9fo00610a. Epub 2019 Sep 9.
• Wang X, Hong H, Wu J. Hen collagen hydrolysate alleviates UVA-induced damage in human dermal fibroblasts. Journal of Functional Foods. 2019;63:103574.
• Mosanya AO, Olasehinde O, Odujoko OO, Etonyeaku AC, Adumah CC, Agbakwuru EA. Comparative study of collagen and elastin content of abdominal wall fascia in inguinal hernia and non-hernia patients in an African population. Hernia. 2020 Dec;24(6):1337-1344. doi: 10.1007/s10029-020-02238-y. Epub 2020 Jun 2.
• Aguilar-Toala JE, Hernandez-Mendoza A, Gonzalez-Cordova AF, Vallejo-Cordoba B, Liceaga AM. Potential role of natural bioactive peptides for development of cosmeceutical skin products. Peptides. 2019 Dec;122:170170. doi: 10.1016/j.peptides.2019.170170. Epub 2019 Sep 28.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Actual): October 31, 2025
• Study Completion (Actual): December 15, 2025

Study Registration Dates

• First Submitted: January 9, 2025
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 14, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: skin; bariatric surgery; skin quality; plastic surgery; abdominoplasty; collagen supplement
• Additional Relevant MeSH Terms: Dietary Carbohydrates; Carbohydrates; Polymers; Macromolecular Substances; Polysaccharides; Glucans; Biopolymers; Starch
• Other Study ID Numbers: Collagen_rct_alexandria_hany

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The analysis will be performed on a blinded dataset after completing the medical/scientific review. All protocol violations will be identified and resolved, and the dataset will be declared complete. All data will be collected in a data management system (Castor EDC, Amsterdam, The Netherlands; https://www.castoredc.com), handled according to Good Clinical Practice guidelines, Data Protection Directive certificate, and complied with Title 21 CFR Part 11. Furthermore, the data centers where all the research data will be stored are certified according to ISO27001, ISO9001, and Dutch NEN7510
• IPD Sharing Time Frame: Available at PI for protocol and SAP ICF, CSR and analytic code after study completion
• IPD Sharing Access Criteria: Available at PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No