Time-Restricted Eating and Staple Food Reduction Combined With App-Supported Exercise for Weight and Glycemic Control (TRE-SFR-EX)
2026年7月21日 更新者：Peking University
A Multicenter Randomized Controlled Trial of Time-Restricted Eating, Staple Food Reduction, and App-Supported Exercise for Weight Loss and Glycemic Improvement in Adults With Obesity and Abnormal Glucose Metabolism
This multicenter, three-arm randomized controlled trial will evaluate the effects of early time-restricted eating and staple food reduction, each combined with an app-supported exercise intervention, on body weight and glycemic control among adults with obesity and abnormal glucose metabolism.
A total of 300 participants aged 18 to 50 years with BMI >=28 kg/m2 and impaired glucose regulation or diabetes will be enrolled at five centers in China and randomized 1:1:1 to app-supported exercise alone, staple food reduction plus app-supported exercise, or early time-restricted eating plus app-supported exercise.
The intervention lasts 12 weeks, followed by a 12-week post-intervention follow-up.
調査の概要
状態
まだ募集していません
詳細な説明
All groups will use the Xiangdong Health app for exercise prescriptions, self-monitoring, and behavioral feedback.
The staple food reduction group will reduce staple food intake by approximately one half at three meals without restriction of eating time.
The early time-restricted eating group will consume food only between 07:00 and 15:00, with water allowed outside the eating window, without prescribed restriction of total daily energy intake.
Outcomes will be measured at baseline, week 12, and week 24, including body weight, glycemic indices, continuous glucose monitoring metrics, body composition, blood pressure, blood biochemistry, urine tests, stool microbiome, dietary recall, physical activity, sleep, appetite, psychological measures, adherence, and adverse events.
研究の種類
介入
入学 (推定)
300
段階
- 適用できない
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
健康ボランティアの受け入れ
いいえ
説明
Inclusion Criteria:
- Age 18 to 50 years, all sexes.
- Body mass index (BMI) >=28 kg/m2.
- Willing and able to comply with study procedures and provide written informed consent.
- Resident living near a participating study site and able to complete scheduled visits.
- No habitual time-restricted eating or other fasting regimen, such as alternate-day fasting or fasting-mimicking diet.
- Abnormal glucose metabolism or diabetes, defined as fasting plasma glucose >5.6 mmol/L or HbA1c >5.7%.
Exclusion Criteria:
- Secondary obesity, such as hypothyroidism or Cushing syndrome.
- Use of weight-loss medication within 90 days before screening, or body weight change >5 kg within 90 days before screening.
- Pregnant, lactating, or planning pregnancy during the study period.
- Severe cardiac, hepatic, or renal dysfunction.
- Severe psychiatric disease or cognitive impairment that prevents cooperation with the study.
- Contraindication to exercise, such as severe osteoarthritis.
- Unable or unwilling to follow the study diet and exercise intervention.
- Long-term use of medications that may significantly affect body weight.
- Active malignancy in any organ system.
- Any other condition that, in the investigator's judgment, may affect efficacy or safety evaluation or make the participant unsuitable for the study.
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
- 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：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：App-Supported Exercise
Participants receive exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
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Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
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実験的：Staple Food Reduction Plus App-Supported Exercise
Participants reduce staple food intake by approximately one half at three meals without restriction of eating time and receive the same app-supported exercise intervention for 12 weeks.
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Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Participants reduce staple food intake by approximately one half at three meals without restriction of eating time.
This dietary strategy is combined with the same app-supported exercise intervention.
|
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実験的：Early Time-Restricted Eating Plus App-Supported Exercise
Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window, without prescribed restriction of total daily energy intake, and receive the same app-supported exercise intervention for 12 weeks.
|
Participants receive individualized exercise prescriptions, self-monitoring, and behavioral feedback through the Xiangdong Health app for 12 weeks.
The exercise program includes progressive aerobic exercise, resistance training, flexibility training, and balance training.
Participants consume food only from 07:00 to 15:00 each day, with water allowed outside the eating window.
Total daily energy intake is not prescribed, and participants are advised to follow the Chinese Dietary Guidelines.
This dietary strategy is combined with the same app-supported exercise intervention.
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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 |
|---|---|---|
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Change in body weight from baseline to week 12
時間枠：Baseline and week 12
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Body weight will be measured using a calibrated scale.
The primary analysis will compare absolute change in body weight from baseline to week 12 among the three randomized groups.
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Baseline and week 12
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Change in CGM-derived glucose exposure and time in range from baseline to week 12
時間枠：Baseline and week 12
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Continuous glucose monitoring (CGM) metrics will include glucose area under the curve and time in range (TIR), defined as the percentage of valid CGM readings between 3.9 and 10.0 mmol/L.
Changes from baseline to week 12 will be compared among the three randomized groups.
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Baseline and week 12
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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 BMI from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Calculated as weight in kg divided by height in meters squared (kg/m²).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in body fat mass from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Change in body fat mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
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Baseline, week 12, and week 24
|
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Change in fasting plasma glucose from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Fasting plasma glucose will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in systolic blood pressure from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Systolic blood pressure will be measured in millimeters of mercury (mmHg).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in CGM-derived mean glucose from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Mean glucose will be calculated from valid CGM readings and reported in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in questionnaire-based behavioral and patient-reported measures from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Questionnaire-based measures include dietary intake, physical activity, sleep, psychological status, appetite, and intervention adherence.
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Baseline, week 12, and week 24
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Adverse events and serious adverse events
時間枠：From baseline through week 24
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Adverse events and serious adverse events will be collected throughout the intervention and follow-up period and summarized by randomized group.
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From baseline through week 24
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Change in Waist circumference from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in Hip circumference from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Measured in centimeters (cm).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in Waist-to-hip ratio (WHR) from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Calculated as a unitless ratio.
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in body fat percentage from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Change in body fat percentage (measured in %) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
|
Baseline, week 12, and week 24
|
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Change in skeletal muscle mass from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Change in skeletal muscle mass (measured in kilograms, kg) from baseline to week 12 and week 24, assessed by bioelectrical impedance analysis.
|
Baseline, week 12, and week 24
|
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Change in glycated hemoglobin (HbA1c) from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Glycated hemoglobin (HbA1c) will be measured as a percentage.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
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Change in fasting plasma insulin from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Fasting plasma insulin will be measured in microunits per milliliter (µIU/mL).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
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Change in homeostatic model assessment of insulin resistance from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) will be calculated from fasting plasma glucose and fasting plasma insulin and reported as a unitless index.
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in diastolic blood pressure from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Diastolic blood pressure will be measured in millimeters of mercury (mmHg).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in heart rate from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Heart rate will be measured in beats per minute (bpm).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
|
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Change in total cholesterol from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Fasting serum total cholesterol will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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|
Change in triglycerides from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Fasting serum triglycerides will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
|
Change in low-density lipoprotein cholesterol from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Fasting serum low-density lipoprotein cholesterol (LDL-C) will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
|
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Change in high-density lipoprotein cholesterol from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Fasting serum high-density lipoprotein cholesterol (HDL-C) will be measured in millimoles per liter (mmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
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Change in alanine aminotransferase from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Serum alanine aminotransferase (ALT) will be measured in units per liter (U/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in aspartate aminotransferase from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Serum aspartate aminotransferase (AST) will be measured in units per liter (U/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in serum creatinine from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Serum creatinine will be measured in micromoles per liter (µmol/L).
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
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|
Change in serum uric acid from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
Serum uric acid will be measured in micromoles per liter (µmol/L).
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in CGM-derived time above range from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Time above range (TAR) will be calculated as the percentage of valid CGM readings above 10.0 mmol/L.
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in CGM-derived time below range from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
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Time below range (TBR) will be calculated as the percentage of valid CGM readings below 3.9 mmol/L.
Changes will be compared among the three randomized groups.
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Baseline, week 12, and week 24
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Change in CGM-derived glucose coefficient of variation from baseline to week 12 and week 24
時間枠：Baseline, week 12, and week 24
|
The glucose coefficient of variation (CV) will be calculated from valid CGM readings and reported as a percentage.
Changes will be compared among the three randomized groups.
|
Baseline, week 12, and week 24
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協力者と研究者
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。
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 (推定)
2026年7月1日
一次修了 (推定)
2026年12月1日
研究の完了 (推定)
2027年4月1日
試験登録日
最初に提出
2026年7月13日
QC基準を満たした最初の提出物
2026年7月21日
最初の投稿 (実際)
2026年7月24日
学習記録の更新
投稿された最後の更新 (実際)
2026年7月24日
QC基準を満たした最後の更新が送信されました
2026年7月21日
最終確認日
2026年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- IRB00001052-26093
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 publicly because the study includes sensitive health information and biological sample data.
De-identified aggregate results will be reported in scientific publications.
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
いいえ
米国FDA規制機器製品の研究
いいえ
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。