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Bariatric SurgeryCOLLAGENNCT06787924

Effect of a Collagen-containing Supplement on Dermal Collagen Content in Metabolic Bariatric Surgery Patients Undergoing Corrective Aesthetic Surgery: A Randomized, Double-blind, Placebo-controlled Trial

A study testing Collagen hydrolyzed peptides and Starch in people with Bariatric Surgery and Abdominoplasty, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This single-center, randomized, placebo-controlled trial evaluated whether perioperative supplementation with a collagen-based oral formulation affected dermal collagen content and postoperative outcomes in adults aged 18-65 years who had previously undergone metabolic/bariatric surgery and were scheduled for breast… Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
What is being tested?
Collagen hydrolyzed peptides and Starch
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
111 participants
Where
1 siteEgypt
Study dates
15 Apr 2025to 31 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Patients aged 18-65 years after metabolic bariatric surgery.
  • Patients will be randomly selected from the hospital's electronic patient system.

Who cannot join

  • 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.
Show all 11Show fewer
  • 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: Smokers or individuals who have recently quit smoking, as smoking is known to reduce collagen synthesis and impair skin healing.
  • Chronic Illnesses: Patients with chronic illnesses such as diabetes, liver disease, or kidney disease, which could impair collagen metabolism or affect skin health.
  • 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.
  • 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.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Facility Name: The department of plastic and reconstructive surgery, Medical Research Institute Hospital, Alexandria University, Alexandria, Egypt

    Alexandria

Other trials in Egypt

About this study

Official title: Effect of a Perioperative Oral Collagen-Based Formulation on Dermal Collagen Content, Wound Outcomes, and Scar Quality in Post-Bariatric Body-Contouring Surgery: A Randomized, Placebo-Controlled Trial

This single-center, randomized, placebo-controlled trial evaluated whether perioperative supplementation with a collagen-based oral formulation affected dermal collagen content and postoperative outcomes in adults aged 18-65 years who had previously undergone metabolic/bariatric surgery and were scheduled for breast and/or abdominal body-contouring surgery. The active formulation (Nutribites Collageen Naturel) provided 11.8 g hydrolyzed bovine collagen peptides, 80 mg vitamin C derived from acerola, and 150 mg hyaluronic acid per daily serving; the comparator was 10 g of food-grade starch daily. Supplementation began eight weeks before surgery and was planned to continue for four weeks after surgery. Tissue was obtained only from skin routinely removed during the planned operation. The primary endpoint was dermal collagen area fraction in picrosirius-red-stained excised skin, quantified under conventional light microscopy. Secondary and other outcomes included collagen I and III immunohistochemical area fractions, epidermal thickness, TGF-beta1 and MMP-1 epidermal immunoreactivity, serum hydroxyproline, postoperative wound complications, and the study-specific modified Vancouver Scar Scale score at 3 and 6 months. Participants were recruited from 15 April to 1 October 2025. A total of 111 participants were randomized, 55 to the collagen-based formulation and 56 to placebo. Final follow-up was completed on 31 May 2026.

Being tested
Collagen hydrolyzed peptides, Starch
Keywords
Collagen, dietary supplements, bariatric surgery, body contouring, abdominoplasty, mammaplasty, wound healing, cicatrix, randomized controlled trial
Medical subject headings
Cicatrix

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Collagen hydrolyzed peptidesDietary supplement

    Also called Nutribites Collageen Naturel

    Daily serving of Nutribites Collageen Naturel providing 11.8 g hydrolyzed bovine collagen peptides, 80 mg vitamin C derived from acerola, and 150 mg hyaluronic acid, dissolved in approximately 200 mL water. Started eight weeks before surgery and planned to continue for four weeks after surgery. The intervention is the combined commercial formulation; effects cannot be attributed to collagen peptides alone.

  • StarchDietary supplement

    10 g food-grade starch once daily in pre-weighed opaque sachets, dissolved in approximately 200 mL water. Started eight weeks before surgery and planned to continue for four weeks after surgery. Packaging and preparation instructions were matched to the active formulation; formal equivalence of taste and odor was not assessed.

Study groups in NCT06787924
Study groupRoleWhat they receive
Placebo (Food-grade starch)Placebo comparatorParticipants received 10 g food-grade starch once daily in pre-weighed opaque sachets, dissolved in approximately 200 mL water. Treatment began eight weeks before surgery and was planned to continue for four weeks after surgery. Packaging and preparation instructions were matched to the active formulation. Formal equivalence of taste and odor was not assessed.
Receives: Dietary Supplement: Starch
Collagen (Nutribites Collageen Naturel)Active comparatorParticipants received a daily serving of Nutribites Collageen Naturel providing 11.8 g hydrolyzed bovine collagen peptides, 80 mg vitamin C derived from acerola, and 150 mg hyaluronic acid, dissolved in approximately 200 mL water. Supplementation began eight weeks before surgery and was planned to continue for four weeks after surgery. Recorded preoperative exposure was 56-59 days among participants who underwent surgery. The intervention was the combined commercial formulation; effects cannot be attributed to collagen peptides alone.
Receives: Dietary Supplement: Collagen hydrolyzed peptides

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dermal collagen area fraction in routinely excised skin

    Percentage of dermal area occupied by collagen in picrosirius-red-stained sections of routinely excised breast and/or abdominal skin obtained during planned body-contouring surgery. Collagen-positive area was quantified by ImageJ under conventional light microscopy in at least five non-overlapping fields within predefined dermal regions. Polarized-light images were used to describe collagen-fiber organization qualitatively, not to identify collagen types. The primary comparison was the adjusted between-group difference in dermal collagen area fraction, with anatomical site included as a fixed effect and participant as a random intercept. Specimens from different operated sites remained separate observations.

    Measured: At planned body-contouring surgery after eight weeks of preoperative supplementation; recorded exposure was 56-59 days among participants who underwent surgery.

Secondary outcomes (5)
  1. Collagen I and collagen III area fractions

    Collagen I and collagen III area fractions were quantified by immunohistochemistry in corresponding dermal regions of routinely excised breast and/or abdominal skin. The collagen I:III ratio was calculated from these immunohistochemical measurements; collagen types were not assigned from polarized picrosirius-red colors.

    Measured: At planned body-contouring surgery after eight weeks of preoperative supplementation; recorded exposure was 56-59 days among participants who underwent surgery.

  2. Epidermal thickness

    Epidermal thickness measured in H\&E-stained sections of routinely excised breast and/or abdominal skin at the time of surgery after approximately 8 weeks of supplementation; the recorded preoperative exposure was 56-59 days among participants with surgery.

    Measured: At planned body-contouring surgery after eight weeks of preoperative supplementation; recorded exposure was 56-59 days among participants who underwent surgery.

  3. TGF-beta1 and MMP-1 expression

    Epidermal-keratinocyte immunoreactivity for TGF-beta1 and MMP-1 in routinely excised breast and/or abdominal skin was evaluated using the study-specific modified immunoreactive score. The positive-cell proportion score (0-3) was multiplied by staining intensity (0-3), yielding a score from 0 to 9. These measurements describe epidermal immunoreactivity and are not direct measures of dermal fibroblast activity.

    Measured: At planned body-contouring surgery after eight weeks of preoperative supplementation; recorded exposure was 56-59 days among participants who underwent surgery.

  4. Serum hydroxyproline

    Serum total hydroxyproline measured at baseline and again one day before surgery, before surgical preparation. The main comparison is the between-group difference in change from baseline. Serum hydroxyproline is a supportive systemic marker and is not the primary tissue endpoint.

    Measured: Baseline before supplementation and one day before planned body-contouring surgery, before surgical preparation.

  5. Postoperative wound complications

    Participant-level postoperative wound complications, including infection, wound dehiscence, seroma, delayed healing, reoperation, and additional antibiotic use, assessed from the postoperative visit at approximately 2 weeks through the final follow-up. Complication severity is classified using the Clavien-Dindo classification.

    Measured: From the postoperative assessment at approximately two weeks through the final assessment at six months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jan 2025
  2. Study start15 Apr 2025
  3. Primary completion15 Dec 2025
  4. Study completion31 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
111 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06787924
Sponsor's protocol ID
Collagen_rct_alexandria_hany
Acronym
COLLAGEN
Status last verified
Oct 2026
First submitted
9 Jan 2025
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Can be asked through the contact person

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.

    PubMed 21480801
  • 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.

    PubMed 29701725
  • 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.

    PubMed 31497829
  • 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.

    PubMed 32488528
  • 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.

    PubMed 31574281

Questions about this trial

What is this clinical trial studying?

A study testing Collagen hydrolyzed peptides and Starch in people with Bariatric Surgery and Abdominoplasty, run by General Committee of Teaching Hospitals and Institutes, Egypt at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dermal collagen area fraction in routinely excised skin (time frame: At planned body-contouring surgery after eight weeks of preoperative supplementation; recorded exposure was 56-59 days among participants who underwent surgery.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06787924, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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