Collagen Supplements and Post-MBS Muscle Mass/Body Image
3 сентября 2026 г. обновлено: 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).
Обзор исследования
Статус
Рекрутинг
Условия
Вмешательство/лечение
Тип исследования
Наблюдательный
Регистрация (Оцененный)
52
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: Seher Şen, Assistant Professor
- Номер телефона: +905393919700
- Электронная почта: seherdalli@gmail.com
Учебное резервное копирование контактов
- Имя: Emre Şen, Master's degree graduate
- Номер телефона: 0 532 163 30 87
Места учебы
-
-
Yıldırım
-
Bursa, Yıldırım, Турция (Туркие)
- Рекрутинг
- Yıldırım Doruk Hastanesi
-
Контакт:
- Номер телефона: 05393919700
- Электронная почта: seher.sen@mudanya.edu.tr
-
-
Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Да
Метод выборки
Невероятностная выборка
Исследуемая популяция
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.
Описание
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
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Body Weight
Временное ограничение: 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
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: Postoperative and 6 months
|
Calculated as (preoperative weight - postoperative weight) / preoperative weight × 100.
|
Postoperative and 6 months
|
|
Percentage of Excess Weight Loss (%EWL)
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Change in Fasting Blood Glucose
Временное ограничение: Preoperative and 6 months
|
Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Fasting Insulin
Временное ограничение: Preoperative and 6 months
|
Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HbA1c
Временное ограничение: Preoperative and 6 months
|
Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in LDL Cholesterol
Временное ограничение: Preoperative and 6 months
|
LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in HDL Cholesterol
Временное ограничение: Preoperative and 6 months
|
HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Triglycerides
Временное ограничение: Preoperative and postoperative 6 months
|
Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in Total Cholesterol
Временное ограничение: Preoperative and postoperative 6 months
|
Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and postoperative 6 months
|
|
Change in ALT
Временное ограничение: Preoperative and 6 months
|
Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in AST
Временное ограничение: Preoperative and 6 months
|
Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Uric Acid
Временное ограничение: Preoperative and 6 months
|
Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Urea
Временное ограничение: Preoperative and 6 months
|
Urea (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hemoglobin
Временное ограничение: Preoperative and 6 months
|
Hemoglobin (g/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Hematocrit
Временное ограничение: Preoperative and 6 months
|
Hematocrit (%) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Ferritin
Временное ограничение: Preoperative and 6 months
|
Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Iron
Временное ограничение: Preoperative and 6 months
|
Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Vitamin B12
Временное ограничение: Preoperative and 6 months
|
Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Folic Acid
Временное ограничение: Preoperative and 6 months
|
Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Magnesium
Временное ограничение: Preoperative and 6 months
|
Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Total Calcium
Временное ограничение: Preoperative and 6 months
|
Total calcium (mg/dL) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Sodium
Временное ограничение: Preoperative and 6 months
|
Serum sodium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
|
Change in Serum Potassium
Временное ограничение: Preoperative and 6 months
|
Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
|
Preoperative and 6 months
|
Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Спонсор
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Действительный)
1 июля 2026 г.
Первичное завершение (Оцененный)
10 января 2027 г.
Завершение исследования (Оцененный)
10 февраля 2027 г.
Даты регистрации исследования
Первый отправленный
29 июля 2026 г.
Впервые представлено, что соответствует критериям контроля качества
3 сентября 2026 г.
Первый опубликованный (Действительный)
9 сентября 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
9 сентября 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
3 сентября 2026 г.
Последняя проверка
1 сентября 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- MUDU-SBE-SS-05
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
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.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .