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

NCT06787924 | Completed

• 1 other identifier: Collagen_rct_alexandria_hany
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Bariatric Surgery; Abdominoplasty; Collagen Synthesis; Skin Physiology; Randomized Controlled Trial; Tissue Remodeling

Keywords

bariatric surgery; collagen supplement; plastic surgery; abdominoplasty; skin; skin quality

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• Serum Parameters hydroxyproline

  biopsy during surgery

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Starch

Dietary Supplement: Starch

Collagen

EXPERIMENTAL

Collagen supplement

Interventions

Collagen hydrolyzed peptides DIETARY_SUPPLEMENT

bovine collagen peptides

Starch DIETARY_SUPPLEMENT

Starch placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \. Allergies or Sensitivities:
• Patients with known allergies or hypersensitivity to collagen or any components of the collagen supplements (e.g., bovine, marine sources).
• \. 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.
• \. 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.
• \. 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.
• \. 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.
• \. Pregnancy or Lactation:
• Pregnant or breastfeeding women should be excluded due to the physiological changes during pregnancy and lactation that could affect collagen metabolism.
• \. 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.
• \. Smoking:

Sponsors & Collaborators

• General Committee of Teaching Hospitals and Institutes, Egypt: lead

Study Sites (1)

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

Alexandria, Egypt

Location

Related Publications (6)

• 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.

  PMID: 21480801 RESULT

• 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.

  PMID: 29701725 RESULT

• 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.

  PMID: 31497829 RESULT

• Wang X, Hong H, Wu J. Hen collagen hydrolysate alleviates UVA-induced damage in human dermal fibroblasts. Journal of Functional Foods. 2019;63:103574.

  RESULT

• 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.

  PMID: 32488528 RESULT

• 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.

  PMID: 31574281 RESULT

MeSH Terms

Interventions

Starch

Intervention Hierarchy (Ancestors)

Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Mohamed Hany Ashour, professor, MD

  Alexandria University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, surgeon

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 22, 2025
• Study Start: April 15, 2025
• Primary Completion: October 31, 2025
• Study Completion: December 15, 2025
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Available at PI for protocol and SAP ICF, CSR and analytic code after study completion
• Access Criteria: Available at PI

Locations

EG (1)