- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07809152
Collagen Supplements and Post-MBS Muscle Mass/Body Image
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).
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Seher Şen, Assistant Professor
- Puhelinnumero: +905393919700
- Sähköposti: seherdalli@gmail.com
Tutki yhteystietojen varmuuskopiointi
- Nimi: Emre Şen, Master's degree graduate
- Puhelinnumero: 0 532 163 30 87
Opiskelupaikat
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-
Yıldırım
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Bursa, Yıldırım, Turkki (Türkiye)
- Rekrytointi
- Yıldırım Doruk Hastanesi
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Ottaa yhteyttä:
- Puhelinnumero: 05393919700
- Sähköposti: seher.sen@mudanya.edu.tr
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
|---|---|
|
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.
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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
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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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Body Weight
Aikaikkuna: 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
|
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Change in Body Shape Questionnaire (BSQ) Score
Aikaikkuna: 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.
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Preoperative and postoperative 6 months
|
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Change in Body Mass Index (BMI)
Aikaikkuna: Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
|
BMI calculated as body weight (kg) divided by height squared (m²).
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
|
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Percentage of Total Weight Loss (%TWL)
Aikaikkuna: Postoperative and 6 months
|
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
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Postoperative and 6 months
|
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Percentage of Excess Weight Loss (%EWL)
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Fasting Blood Glucose
Aikaikkuna: Preoperative and 6 months
|
Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Fasting Insulin
Aikaikkuna: Preoperative and 6 months
|
Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in HbA1c
Aikaikkuna: Preoperative and 6 months
|
Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in LDL Cholesterol
Aikaikkuna: Preoperative and 6 months
|
LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in HDL Cholesterol
Aikaikkuna: Preoperative and 6 months
|
HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Triglycerides
Aikaikkuna: Preoperative and postoperative 6 months
|
Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in Total Cholesterol
Aikaikkuna: Preoperative and postoperative 6 months
|
Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in ALT
Aikaikkuna: Preoperative and 6 months
|
Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in AST
Aikaikkuna: Preoperative and 6 months
|
Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Uric Acid
Aikaikkuna: Preoperative and 6 months
|
Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
|
Change in Urea
Aikaikkuna: Preoperative and 6 months
|
Urea (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Hemoglobin
Aikaikkuna: Preoperative and 6 months
|
Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Hematocrit
Aikaikkuna: Preoperative and 6 months
|
Hematocrit (%) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Ferritin
Aikaikkuna: Preoperative and 6 months
|
Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Iron
Aikaikkuna: Preoperative and 6 months
|
Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Vitamin B12
Aikaikkuna: Preoperative and 6 months
|
Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Folic Acid
Aikaikkuna: Preoperative and 6 months
|
Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Magnesium
Aikaikkuna: Preoperative and 6 months
|
Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
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Change in Total Calcium
Aikaikkuna: Preoperative and 6 months
|
Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Serum Sodium
Aikaikkuna: Preoperative and 6 months
|
Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Serum Potassium
Aikaikkuna: Preoperative and 6 months
|
Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
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