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Relationship between Collagen-Containing supplement use and muscle mass and body image following metabolic and bariatric surgery: a prospective observational study

NCT ID NCT07809152

NEW Sponsor: Mudanya University Source: ClinicalTrials.gov ↗

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First seen Sep 09, 2026 · Last updated Sep 09, 2026

Summary

This prospective, observational cohort study aims to evaluate whether the use of collagen-containing supplements is associated with differences in muscle mass, body composition, and body image among patients who have undergone sleeve gastrectomy (SG). The study will be conducted at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye, between May 2026 and March 2027, and will enroll adult patients (aged 18-65 years) who meet current ASMBS/IFSO eligibility criteria for metabolic and bariatric surgery. Participants will be naturally allocated into two observational groups based on their own choice to use or not use collagen-containing supplements; no supplement will be provided or recommended by the study team, and no intervention will be made to participants' standard clinical care. All patients will be followed according to routine clinical practice preoperatively and at 2 weeks, 1 month, 3 months, and 6 months postoperatively. Primary outcome measures include anthropometric parameters (body weight, BMI, fat mass, fat mass percentage, fat-free mass, muscle mass, percentage of weight loss, percentage of excess weight loss, waist and hip circumference) assessed via bioelectrical impedance analysis (Tanita MC-780 MA), and body image assessed using the Turkish-validated Body Shape Questionnaire (BSQ). Secondary outcomes include biochemical parameters, comorbidities, and macronutrient intake data obtained from 3-day dietary records analyzed using the BEBİS nutrition software. The study hypothesizes that patients using collagen-containing supplements will show significant differences in muscle mass and body composition parameters compared with non-users, and that supplement use will be significantly associated with BSQ scores. A sample size of approximately 52 participants per group was calculated using G\*Power 3.1 (one-way ANOVA, Cohen's f = 0.25, α = 0.05, power = 0.80).

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Study facts

What this study's own registry entry says, in plain language.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Adult patients aged 18-65 years who underwent sleeve gastrectomy and are under routine postoperative follow-up at the General Surgery outpatient clinic of a private hospital in Bursa, Türkiye. Eligible patients meet current ASMBS/IFSO criteria for metabolic and bariatric surgery (BMI ≥ 35 kg/m², or BMI 30-34.9 kg/m² with an obesity-related metabolic comorbidity). Participants are naturally grouped according to their own preference to use or not use a collagen-containing supplement following surgery.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients with a BMI ≥ 35 kg/m², regardless of the presence of comorbidities * Patients with a BMI of 30-34.9 kg/m² who have an obesity-related metabolic disease and are considered eligible for surgical treatment * Patients who have undergone metabolic and bariatric surgery (MBS) in accordance with current ASMBS/IFSO guidelines (Eisenberg et al., 2022) * Patients under regular postoperative follow-up * Age 18-65 years Exclusion Criteria: * Inflammatory bowel disease * History of upper gastrointestinal bleeding * Severe psychiatric disorders * Active cancer diagnosis * Pregnancy or breastfeeding * Alcohol or substance dependence * Physical limitations preventing participation in exercise

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Conditions

The condition(s) this trial relates to.

Obesity obesity disorder Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bariatric surgery Body composition Body image Collagen protein Metabolic and bariatric surgery Muscle composition Obesity & overweight

How to take part

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  1. The places running it

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  2. The official record

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    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Yıldırım Doruk Hastanesi

    RECRUITING

    Bursa, Yıldırım, Turkey (Türkiye)

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