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).
調査の概要
状態
募集
研究の種類
観察的
入学 (推定)
52
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Seher Şen, Assistant Professor
- 電話番号：+905393919700
- メール：seherdalli@gmail.com
研究連絡先のバックアップ
- 名前：Emre Şen, Master's degree graduate
- 電話番号：0 532 163 30 87
研究場所
-
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Yıldırım
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Bursa、Yıldırım、トルコ（Türkiye）
- 募集
- Yıldırım Doruk Hastanesi
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コンタクト：
- 電話番号：05393919700
- メール：seher.sen@mudanya.edu.tr
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
はい
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in Body Weight
時間枠：Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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Body weight (kg) measured using a Tanita MC-780 MA device.
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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Change in Body Shape Questionnaire (BSQ) Score
時間枠：Preoperative and postoperative 6 months
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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)
時間枠：Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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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)
時間枠：Postoperative and 6 months
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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)
時間枠：Postoperative and 6 months
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Calculated as (preoperative weight - postoperative weight) / (preoperative weight - ideal weight) × 100.
Ideal body weight was calculated assuming a BMI of 25 kg/m².
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Postoperative and 6 months
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Change in Fat Mass
時間枠：Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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Fat mass (kg) assessed by multi-frequency bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
|
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Change in Fat Mass Percentage
時間枠：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.
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
|
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Change in Muscle Mass
時間枠：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.
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
|
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Change in Muscle Mass Percentage
時間枠：Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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Muscle mass expressed as a percentage of total body weight, assessed by bioelectrical impedance analysis (BIA) using a Tanita MC-780 MA device.
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Preoperative, and postoperative 2 weeks, 1 month, 3 months, and 6 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in Fasting Blood Glucose
時間枠：Preoperative and 6 months
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Fasting blood glucose (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Fasting Insulin
時間枠：Preoperative and 6 months
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Fasting insulin (µIU/mL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in HbA1c
時間枠：Preoperative and 6 months
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Glycated hemoglobin (HbA1c, %) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in LDL Cholesterol
時間枠：Preoperative and 6 months
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LDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in HDL Cholesterol
時間枠：Preoperative and 6 months
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HDL cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Triglycerides
時間枠：Preoperative and postoperative 6 months
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Triglycerides (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and postoperative 6 months
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Change in Total Cholesterol
時間枠：Preoperative and postoperative 6 months
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Total cholesterol (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and postoperative 6 months
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Change in ALT
時間枠：Preoperative and 6 months
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Alanine aminotransferase (ALT, U/L) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in AST
時間枠：Preoperative and 6 months
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Aspartate aminotransferase (AST, U/L) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Uric Acid
時間枠：Preoperative and 6 months
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Uric acid (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Urea
時間枠：Preoperative and 6 months
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Urea (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Hemoglobin
時間枠：Preoperative and 6 months
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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
時間枠：Preoperative and 6 months
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Hematocrit (%) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Ferritin
時間枠：Preoperative and 6 months
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Ferritin (ng/mL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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Change in Serum Iron
時間枠：Preoperative and 6 months
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Serum iron (µg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Vitamin B12
時間枠：Preoperative and 6 months
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Vitamin B12 (pg/mL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Folic Acid
時間枠：Preoperative and 6 months
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Folic acid (ng/mL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Magnesium
時間枠：Preoperative and 6 months
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Magnesium (mg/dL) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
|
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Change in Total Calcium
時間枠：Preoperative and 6 months
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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
時間枠：Preoperative and 6 months
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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
時間枠：Preoperative and 6 months
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Serum potassium (mEq/L) obtained from routine clinical laboratory follow-up.
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Preoperative and 6 months
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ここでは、この調査に関係する人々や組織を見つけることができます。
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研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年7月1日
一次修了 (推定)
2027年1月10日
研究の完了 (推定)
2027年2月10日
試験登録日
最初に提出
2026年7月29日
QC基準を満たした最初の提出物
2026年9月3日
最初の投稿 (実際)
2026年9月9日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月9日
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- MUDU-SBE-SS-05
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
IPD プランの説明
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.
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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