Clinical trial NCT06787924: Impact of Collagen Supplements on Dermal Collagen in Plastic and Bariatric Surgery Patients
Official title: Effect of Collagen Supplements on Dermal Collagen Content Within Skin Biopsies of Plastic Surgery and Metabolic Bariatric Surgery Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Bariatric Surgery
Abdominoplasty
Collagen Synthesis
Skin Physiology
Randomized Controlled Trial
Tissue Remodeling
Keywords: bariatric surgery
collagen supplement
plastic surgery
abdominoplasty
skin
skin quality
Lead sponsor: General Committee of Teaching Hospitals and Institutes, Egypt
Sponsor class: OTHER_GOV
First posted: 2025-01-22
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Wound Healing Parameters vascularity
timeFrame: Biopsy during surgery
measure: Assessment of Wound Healing Parameters pigmentation
timeFrame: Biopsy during surgery
measure: Assessment of Wound Healing Parameters thickness
timeFrame: Biopsy during surgery
measure: Assessment of Wound Healing Parameters pliability
timeFrame: Biopsy during surgery
Secondary outcomes:
measure: Serum Parameters hydroxyproline
timeFrame: biopsy during surgery
Other outcomes:
Locations:
Study officials:
affiliation: Alexandria University
name: Mohamed Hany Ashour, professor, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
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citation: Wang X, Hong H, Wu J. Hen collagen hydrolysate alleviates UVA-induced damage in human dermal fibroblasts. Journal of Functional Foods. 2019;63:103574.
citation: 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.
citation: 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.