Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

Collagen Supplements and Post-MBS Muscle Mass/Body Image

3. September 2026 aktualisiert von: 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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

52

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

  • Name: Emre Şen, Master's degree graduate
  • Telefonnummer: 0 532 163 30 87

Studienorte

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Ja

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Nahrungsergänzungsmittel: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Body Weight
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: Postoperative and 6 months
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
Postoperative and 6 months
Percentage of Excess Weight Loss (%EWL)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Mudanya University

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Juli 2026

Primärer Abschluss (Geschätzt)

10. Januar 2027

Studienabschluss (Geschätzt)

10. Februar 2027

Studienanmeldedaten

Zuerst eingereicht

29. Juli 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. September 2026

Zuerst gepostet (Tatsächlich)

9. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

9. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

3. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MUDU-SBE-SS-05

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Abonnieren