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Collagen Supplements and Post-MBS Muscle Mass/Body Image

3. september 2026 oppdatert av: 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).

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Studietype

Observasjonsmessig

Registrering (Antatt)

52

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

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

Studiesteder

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Ja

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Kosttilskudd: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in Body Weight
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Postoperative and 6 months
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
Postoperative and 6 months
Percentage of Excess Weight Loss (%EWL)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mudanya University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. juli 2026

Primær fullføring (Antatt)

10. januar 2027

Studiet fullført (Antatt)

10. februar 2027

Datoer for studieregistrering

Først innsendt

29. juli 2026

Først innsendt som oppfylte QC-kriteriene

3. september 2026

Først lagt ut (Faktiske)

9. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

9. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

3. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • MUDU-SBE-SS-05

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

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.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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