Diet and WB-EMS Effects in Obesity (DEMO-OB)
Effects of Energy-Restricted Diet and Whole-Body Electromyostimulation (WB-EMS) on Myokine-Adipokine Interaction, Appetite Regulation, and Body Composition in Obese Individuals: A Randomized Controlled Trial
Obesity is a major global health problem associated with metabolic dysfunction, altered adipokine signaling, and impaired appetite regulation. Conventional weight loss strategies such as calorie restriction often result in compensatory physiological adaptations, including increased appetite and loss of lean body mass, which may limit long-term effectiveness.
Whole-body electromyostimulation (WB-EMS) is an emerging, time-efficient intervention that induces simultaneous muscle activation and may improve metabolic health. However, the underlying molecular mechanisms, particularly the interaction between myokines and adipokines, remain insufficiently understood.
This randomized controlled trial aims to investigate the effects of an energy-restricted diet combined with WB-EMS on myokine-adipokine interaction, appetite regulation, and body composition in obese individuals. Participants will be randomly assigned to either a diet-only group or a diet plus WB-EMS group for 8 weeks.
Primary outcomes include changes in serum irisin levels. Secondary outcomes include myostatin, leptin, adiponectin, FGF-21, ghrelin, GLP-1, body composition parameters, and eating behavior. The findings of this study are expected to provide novel insights into the physiological and molecular effects of WB-EMS as a complementary strategy in obesity management.
調査の概要
状態
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Muharrem Gökhan Beydağı, PhD
- 電話番号：+905323581105
- メール：mgbeydagi@firat.edu.tr
研究連絡先のバックアップ
- 名前：Murat Acik, PhD
- 電話番号：+90 544 111 81 24
- メール：macik@firat.edu.tr
研究場所
-
-
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Diyarbakır、トルコ（Türkiye）
- Dicle University
-
コンタクト：
- Feray Cagiran Yilmaz, assistant professor
- メール：feraycagiran@hotmail.com
-
Elâzığ、トルコ（Türkiye）
- Firat University
-
-
参加基準
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
説明
Inclusion Criteria:
- Age between 18 and 65 years
- Body mass index (BMI) ≥ 30 kg/m²
- Sedentary lifestyle (less than 2 hours of structured exercise per week)
- Willingness to participate and provide written informed consent
Exclusion Criteria:
- Presence of pacemaker or implantable cardioverter-defibrillator
- Known cardiovascular disease or severe chronic illness
- Pregnancy or breastfeeding
- Uncontrolled diabetes or severe metabolic disorders
- Active malignancy or cancer treatment
- Severe renal or hepatic failure
- Acute infection or inflammatory disease
- Orthopedic conditions limiting physical activity
- Use of medications affecting body composition or appetite (e.g., corticosteroids, weight-loss drugs)
- Regular resistance training within the last 3 months
- Substance abuse, including alcohol or drug dependency
- Psychiatric or cognitive conditions affecting adherence to the study protocol
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：Diet Only
Participants receive an individualized energy-restricted diet program.
|
A personalized diet with approximately 750 kcal/day energy deficit.
|
|
実験的：Diet + WB-EMS
Participants receive an energy-restricted diet combined with whole-body electromyostimulation (WB-EMS).
|
A personalized diet with approximately 750 kcal/day energy deficit.
Whole-body electromyostimulation applied 2-3 times per week for 8 weeks under supervision.
|
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 serum irisin levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating irisin levels measured by ELISA.
|
Baseline to 8 weeks
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Change in serum myostatin levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating myostatin levels measured by ELISA.
|
Baseline to 8 weeks
|
|
Change in serum leptin levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating leptin levels.
|
Baseline to 8 weeks
|
|
Change in serum adiponectin levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating adiponectin levels.
|
Baseline to 8 weeks
|
|
Change in serum FGF-21 levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating fibroblast growth factor-21 levels.
|
Baseline to 8 weeks
|
|
Change in serum ghrelin levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating ghrelin levels.
|
Baseline to 8 weeks
|
|
Change in serum GLP-1 levels
時間枠：Baseline to 8 weeks
|
Assessment of change in circulating GLP-1 levels.
|
Baseline to 8 weeks
|
|
Change in fat mass
時間枠：Baseline to 8 weeks
|
Assessment of change in total body fat mass measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
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Change in fat-free mass
時間枠：Baseline to 8 weeks
|
Assessment of change in fat-free mass measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
|
Change in body fat percentage
時間枠：Baseline to 8 weeks
|
Assessment of change in body fat percentage measured by bioelectrical impedance analysis (BIA).
|
Baseline to 8 weeks
|
|
Change in eating behavior scores
時間枠：Baseline to 8 weeks
|
Assessment of eating behavior using the Three-Factor Eating Questionnaire-Revised 21 (TFEQ-R21).
The questionnaire evaluates cognitive restraint, uncontrolled eating, and emotional eating behaviors.
Scores range from 21 to 84, with higher scores indicating more problematic eating behaviors.
|
Baseline to 8 weeks
|
協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- FU_MGBeydagi_EMS_B_2026/05
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?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。