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

NCT ID: NCT06787924

Last Updated: 2025-09-16

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-15
• Study Completion Date: 2025-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Starch

Group Type: PLACEBO_COMPARATOR

Starch

Intervention Type: DIETARY_SUPPLEMENT

Starch placebo

Collagen

Collagen supplement

Group Type: EXPERIMENTAL

No interventions assigned to this group

Interventions

Collagen hydrolyzed peptides

bovine collagen peptides

Intervention Type: DIETARY_SUPPLEMENT

Starch

Starch placebo

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

General Committee of Teaching Hospitals and Institutes, Egypt

OTHER_GOV

Sponsor Role: lead

Responsible Party

Mohamed Hany Ashour

Professor, surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohamed Hany Ashour, professor, MD

Role: PRINCIPAL_INVESTIGATOR

Alexandria University

Locations

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

Alexandria, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Mohamed Hany Ashour, Professor, MD

Role: CONTACT

mohamed.ashour@alexu.edu.eg

+201002600970

Bart Torensma, PhD

Role: CONTACT

bart@torensmaresearch.nl

+31641389070

Facility Contacts

Mohamed H M. H. Ashour, MD, Ph.D. (Professor)

Role: primary

mohamed.ashour@alexu.edu.eg

+20 100 2600970

References

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.

Reference Type: BACKGROUND

PMID: 21480801 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 29701725 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31497829 (View on PubMed)

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

Reference Type: BACKGROUND

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.

Reference Type: BACKGROUND

PMID: 32488528 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 31574281 (View on PubMed)

Other Identifiers

Collagen_rct_alexandria_hany

Identifier Type: -

Identifier Source: org_study_id