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Collagen Supplements and Post-MBS Muscle Mass/Body Image

3 september 2026 uppdaterad 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).

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Studietyp

Observationell

Inskrivning (Beräknad)

52

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studera Kontakt Backup

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

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / 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.
Kosttillskott: 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.

Vad mäter studien?

Primära resultatmått

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

Sekundära resultatmått

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

Samarbetspartners och utredare

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Sponsor

Mudanya University

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 juli 2026

Primärt slutförande (Beräknad)

10 januari 2027

Avslutad studie (Beräknad)

10 februari 2027

Studieregistreringsdatum

Först inskickad

29 juli 2026

Först inskickad som uppfyllde QC-kriterierna

3 september 2026

Första postat (Faktisk)

9 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

9 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • MUDU-SBE-SS-05

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

IPD-planbeskrivning

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.

Läkemedels- och apparatinformation, studiedokument

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