- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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).
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Seher Şen, Assistant Professor
- Phone Number: +905393919700
- Email: seherdalli@gmail.com
Study Contact Backup
- Name: Emre Şen, Master's degree graduate
- Phone Number: 0 532 163 30 87
Study Locations
-
-
Yıldırım
-
Bursa, Yıldırım, Turkey (Türkiye)
- Recruiting
- Yıldırım Doruk Hastanesi
-
Contact:
- Phone Number: 05393919700
- Email: seher.sen@mudanya.edu.tr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Body Weight
Time Frame: 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
Time Frame: 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)
Time Frame: 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)
Time Frame: Postoperative and 6 months
|
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
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Postoperative and 6 months
|
|
Percentage of Excess Weight Loss (%EWL)
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Fasting Blood Glucose
Time Frame: Preoperative and 6 months
|
Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Fasting Insulin
Time Frame: Preoperative and 6 months
|
Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HbA1c
Time Frame: Preoperative and 6 months
|
Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in LDL Cholesterol
Time Frame: Preoperative and 6 months
|
LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HDL Cholesterol
Time Frame: Preoperative and 6 months
|
HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Triglycerides
Time Frame: Preoperative and postoperative 6 months
|
Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in Total Cholesterol
Time Frame: Preoperative and postoperative 6 months
|
Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in ALT
Time Frame: Preoperative and 6 months
|
Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in AST
Time Frame: Preoperative and 6 months
|
Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Uric Acid
Time Frame: Preoperative and 6 months
|
Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Urea
Time Frame: Preoperative and 6 months
|
Urea (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hemoglobin
Time Frame: Preoperative and 6 months
|
Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hematocrit
Time Frame: Preoperative and 6 months
|
Hematocrit (%) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Ferritin
Time Frame: Preoperative and 6 months
|
Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Iron
Time Frame: Preoperative and 6 months
|
Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Vitamin B12
Time Frame: Preoperative and 6 months
|
Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Folic Acid
Time Frame: Preoperative and 6 months
|
Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Magnesium
Time Frame: Preoperative and 6 months
|
Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Total Calcium
Time Frame: Preoperative and 6 months
|
Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Sodium
Time Frame: Preoperative and 6 months
|
Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Potassium
Time Frame: Preoperative and 6 months
|
Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MUDU-SBE-SS-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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