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COMPLETED

NCT06787924

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

Sponsor: General Committee of Teaching Hospitals and Institutes, Egypt

View on ClinicalTrials.gov

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 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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

111

Start Date

2025-04-15

Completion Date

2026-05-31

Last Updated

2026-10-28

Healthy Volunteers

Yes

Conditions

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

Interventions

DIETARY_SUPPLEMENT

Collagen hydrolyzed peptides

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.

DIETARY_SUPPLEMENT

Starch

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.

Inclusion Criteria: * Patients aged 18-65 years after metabolic bariatric surgery. * Patients will be randomly selected from the hospital's electronic patient system. Exclusion Criteria: * 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: 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.

Locations (1)

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

Alexandria, Egypt