Collagen Supplements and Post-MBS Muscle Mass/Body Image
2026年9月3日 更新者：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).
研究概览
研究类型
观察性的
注册 (估计的)
52
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Seher Şen, Assistant Professor
- 电话号码：+905393919700
- 邮箱：seherdalli@gmail.com
研究联系人备份
- 姓名：Emre Şen, Master's degree graduate
- 电话号码：0 532 163 30 87
学习地点
-
-
Yıldırım
-
Bursa、Yıldırım、土耳其（türkiye）
- 招聘中
- Yıldırım Doruk Hastanesi
-
接触：
- 电话号码：05393919700
- 邮箱：seher.sen@mudanya.edu.tr
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
取样方法
非概率样本
研究人群
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.
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
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.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Body Weight
大体时间：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
大体时间：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)
大体时间：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)
大体时间：Postoperative and 6 months
|
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
|
Postoperative and 6 months
|
|
Percentage of Excess Weight Loss (%EWL)
大体时间：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
大体时间：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
大体时间：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
大体时间：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
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in Fasting Blood Glucose
大体时间：Preoperative and 6 months
|
Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Fasting Insulin
大体时间：Preoperative and 6 months
|
Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HbA1c
大体时间：Preoperative and 6 months
|
Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in LDL Cholesterol
大体时间：Preoperative and 6 months
|
LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HDL Cholesterol
大体时间：Preoperative and 6 months
|
HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Triglycerides
大体时间：Preoperative and postoperative 6 months
|
Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in Total Cholesterol
大体时间：Preoperative and postoperative 6 months
|
Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in ALT
大体时间：Preoperative and 6 months
|
Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in AST
大体时间：Preoperative and 6 months
|
Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Uric Acid
大体时间：Preoperative and 6 months
|
Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Urea
大体时间：Preoperative and 6 months
|
Urea (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hemoglobin
大体时间：Preoperative and 6 months
|
Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hematocrit
大体时间：Preoperative and 6 months
|
Hematocrit (%) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Ferritin
大体时间：Preoperative and 6 months
|
Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Iron
大体时间：Preoperative and 6 months
|
Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Vitamin B12
大体时间：Preoperative and 6 months
|
Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Folic Acid
大体时间：Preoperative and 6 months
|
Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Magnesium
大体时间：Preoperative and 6 months
|
Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Total Calcium
大体时间：Preoperative and 6 months
|
Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Sodium
大体时间：Preoperative and 6 months
|
Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Potassium
大体时间：Preoperative and 6 months
|
Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2026年7月1日
初级完成 (估计的)
2027年1月10日
研究完成 (估计的)
2027年2月10日
研究注册日期
首次提交
2026年7月29日
首先提交符合 QC 标准的
2026年9月3日
首次发布 (实际的)
2026年9月9日
研究记录更新
最后更新发布 (实际的)
2026年9月9日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- MUDU-SBE-SS-05
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
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.
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.