Tato stránka byla automaticky přeložena a přesnost překladu není zaručena. Podívejte se prosím na anglická verze pro zdrojový text.

Collagen Supplements and Post-MBS Muscle Mass/Body Image

3. září 2026 aktualizováno: Seher Şen, Mudanya University

Relationship Between Collagen-Containing Supplement Use and Muscle Mass and Body Image Following Metabolic and Bariatric Surgery: A Prospective Observational Study

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).

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Typ studie

Pozorovací

Zápis (Odhadovaný)

52

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: Seher Şen, Assistant Professor
  • Telefonní číslo: +905393919700
  • E-mail: seherdalli@gmail.com

Studijní záloha kontaktů

  • Jméno: Emre Şen, Master's degree graduate
  • Telefonní číslo: 0 532 163 30 87

Studijní místa

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ano

Metoda odběru vzorků

Vzorek nepravděpodobnosti

Studijní populace

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.

Popis

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

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

Kohorty a intervence

Skupina / kohorta
Intervence / Léčba
1. Grup
Group/Cohort Label: Collagen Supplement Users (Kolajen Kullananlar) Description: Participants who, based on their own preference, use a collagen-containing supplement product following sleeve gastrectomy, without any intervention or recommendation from the study team.
Doplněk stravy: Collagen-containing supplement
Collagen-containing supplement products used at the participants' own discretion following sleeve gastrectomy. The type of product, daily dosage, and duration of use were self-reported by participants
2. Grup
Group/Cohort Label: Non-Users of Collagen Supplement (Kolajen Kullanmayanlar) Description: Participants who do not use any collagen-containing supplement product following sleeve gastrectomy, followed under routine clinical care.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Body Weight
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Body weight (kg) measured using a Tanita MC-780 MA device.
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Change in Body Shape Questionnaire (BSQ) Score
Časové okno: Preoperative and postoperative 6 months
Body image concerns were assessed using the Body Shape Questionnaire (BSQ-34), a validated instrument for the Turkish population. This 34-item self-report scale evaluates weight-related concerns and dissatisfaction with body shape over the preceding four weeks. Each item is scored from 1 (never) to 6 (always), with a total score range of 34 to 204. Higher scores indicate greater dissatisfaction with body shape, i.e., a worse outcome.
Preoperative and postoperative 6 months
Change in Body Mass Index (BMI)
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
BMI calculated as body weight (kg) divided by height squared (m²).
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Percentage of Total Weight Loss (%TWL)
Časové okno: Postoperative and 6 months
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
Postoperative and 6 months
Percentage of Excess Weight Loss (%EWL)
Časové okno: Postoperative and 6 months
Calculated as (preoperative weight - postoperative weight) / (preoperative weight - ideal weight) × 100. Ideal body weight was calculated assuming a BMI of 25 kg/m².
Postoperative and 6 months
Change in Fat Mass
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Fat mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Change in Fat Mass Percentage
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Fat mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Change in Muscle Mass
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Muscle mass (kg) assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Change in Muscle Mass Percentage
Časové okno: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
Muscle mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change in Fasting Blood Glucose
Časové okno: Preoperative and 6 months
Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Fasting Insulin
Časové okno: Preoperative and 6 months
Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in HbA1c
Časové okno: Preoperative and 6 months
Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in LDL Cholesterol
Časové okno: Preoperative and 6 months
LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in HDL Cholesterol
Časové okno: Preoperative and 6 months
HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Triglycerides
Časové okno: Preoperative and postoperative 6 months
Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and postoperative 6 months
Change in Total Cholesterol
Časové okno: Preoperative and postoperative 6 months
Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and postoperative 6 months
Change in ALT
Časové okno: Preoperative and 6 months
Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in AST
Časové okno: Preoperative and 6 months
Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Uric Acid
Časové okno: Preoperative and 6 months
Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Urea
Časové okno: Preoperative and 6 months
Urea (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Hemoglobin
Časové okno: Preoperative and 6 months
Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Hematocrit
Časové okno: Preoperative and 6 months
Hematocrit (%) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Ferritin
Časové okno: Preoperative and 6 months
Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Serum Iron
Časové okno: Preoperative and 6 months
Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Vitamin B12
Časové okno: Preoperative and 6 months
Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Folic Acid
Časové okno: Preoperative and 6 months
Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Magnesium
Časové okno: Preoperative and 6 months
Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Total Calcium
Časové okno: Preoperative and 6 months
Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Serum Sodium
Časové okno: Preoperative and 6 months
Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months
Change in Serum Potassium
Časové okno: Preoperative and 6 months
Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
Preoperative and 6 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Mudanya University

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

1. července 2026

Primární dokončení (Odhadovaný)

10. ledna 2027

Dokončení studie (Odhadovaný)

10. února 2027

Termíny zápisu do studia

První předloženo

29. července 2026

První předloženo, které splnilo kritéria kontroly kvality

3. září 2026

První zveřejněno (Aktuální)

9. září 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

9. září 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

3. září 2026

Naposledy ověřeno

1. září 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • MUDU-SBE-SS-05

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Individual participant data will not be shared, as this was not planned or consented to as part of the study protocol. Data confidentiality was assured to participants at the time of enrollment, and no data sharing infrastructure or agreement is in place beyond the study team.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

Předplatit