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Intragastric Balloon and Time-Restricted Eating for Weight Loss in Adults With Overweight or Obesity

2026年11月7日 更新者：Seher Şen、Mudanya University

Effects of Intragastric Balloon and Time-Restricted Intermittent Fasting Diet on Weight Loss and Metabolic Parameters in Adults With Overweight and Obesity

The goal of this non-randomized clinical study is to learn whether an intragastric balloon (IGB) and time-restricted eating (TRE; 16-hour daily fast with an 8-hour eating window), used alone or together, improve weight loss, body composition, and metabolic parameters in adults aged 18 to 65 years with overweight or obesity (body mass index 27.0 to 39.9 kg/m²). Participants are followed in four groups according to whether they have an IGB (placed as part of routine clinical care, not assigned by the study) and whether they choose to follow TRE: (1) standard nutrition therapy, (2) IGB plus standard nutrition therapy, (3) TRE plus standard nutrition therapy, and (4) IGB plus TRE plus standard nutrition therapy. All participants receive the same individualized energy-restricted diet, dietitian follow-up, behavioral education, and physical activity advice. Body weight and body composition are measured at baseline, 3 months, and 6 months; routine laboratory results are recorded at baseline and 6 months.

研究概览

地位

招聘中

条件

干预/治疗

详细说明

This is a prospective, single-center, non-randomized, exploratory (pilot) study with a 2×2 factorial structure. The two factors are intragastric balloon (IGB; present/absent) and time-restricted eating (TRE; yes/no). IGB placement is not a study procedure: it is performed as routine clinical care according to the physician's indication and the patient's preference, and the investigators have no role in that decision. TRE is offered in the dietetics outpatient clinic; participants who wish to follow it are allocated to the TRE groups, and those who do not are followed with standard nutrition therapy alone.

All groups receive the same frequency of dietitian visits, the same behavioral education, comparable energy targets, and the same physical activity advice (7,500 to 10,000 steps per day), so that groups differ only in IGB status and TRE. Body composition is measured by multi-frequency bioelectrical impedance analysis. Laboratory values are taken from routine clinical test results; no additional blood samples are drawn. Dietary intake is assessed with 3-day food records and physical activity with participants' smartphone step counters.

At least 15 participants per group (60 in total) are planned. Main and interaction effects of IGB and TRE will be analyzed with two-way analysis of variance or general linear models, and changes over time with repeated-measures analysis of variance or linear mixed models, adjusting for age, sex, baseline body mass index, comorbidities, physical activity, and energy intake.

研究类型

介入性

注册 (估计的)

60

阶段

  • 不适用

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

学习地点

  • 土耳其（türkiye）
    • Yıldırım
      • Bursa、Yıldırım、土耳其（türkiye）
        • 招聘中
        • Yıldırım Doruk Hastanesi
        • 接触：
          • Yıldırım Doruk Hastanesi Seher ŞEN, Assistant Professor
          • 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

18年 至 65年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Age 18 to 65 years
  • Body mass index (BMI) 27.0 to 39.9 kg/m²; for BMI 27.0 to 29.9 kg/m², at least one obesity-related comorbidity (e.g., insulin resistance, type 2 diabetes mellitus, hypertension, dyslipidemia)
  • BMI of 27 kg/m² or higher for at least 2 years
  • History of unsuccessful non-surgical weight-loss attempts
  • Willingness to participate and written informed consent

Exclusion Criteria:

  • Inflammatory bowel disease or other inflammatory conditions of the gastrointestinal tract (including esophagitis and hiatal hernia of 2 cm or larger)
  • Previous gastrointestinal surgery
  • History of upper gastrointestinal bleeding
  • Gastroparesis
  • Severe psychiatric illness
  • Active malignancy
  • Pregnancy or breastfeeding
  • Alcohol or substance dependence
  • Physical limitation preventing exercise
  • Contraindication to intragastric balloon placement

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

  • 主要用途：治疗
  • 分配：非随机化
  • 介入模型：阶乘赋值
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
有源比较器：Standard Nutrition Therapy

Participants without an intragastric balloon who receive standard energy-restricted nutrition therapy only.
行为的：Standard Hypocaloric Nutrition Therapy

Individualized balanced diet with approximately 25% energy restriction from the estimated daily energy requirement (typically 1000 to 1400 kcal/day; protein 1.0 to 1.5 g/kg/day, carbohydrate 35 to 50% and fat 25 to 35% of energy), with regular dietitian follow-up, behavioral education, and advice to walk 7,500 to 10,000 steps per day.
有源比较器：IGB + Standard Nutrition Therapy

Participants with an intragastric balloon (IGB) placed as part of routine clinical care who receive standard energy-restricted nutrition therapy.
行为的：Standard Hypocaloric Nutrition Therapy

Individualized balanced diet with approximately 25% energy restriction from the estimated daily energy requirement (typically 1000 to 1400 kcal/day; protein 1.0 to 1.5 g/kg/day, carbohydrate 35 to 50% and fat 25 to 35% of energy), with regular dietitian follow-up, behavioral education, and advice to walk 7,500 to 10,000 steps per day.

设备：Intragastric Balloon

Endoscopically placed intragastric balloon, performed as part of routine clinical care based on physician indication and patient preference; placement is not assigned by the study. Diet after placement progresses through clear liquid, full liquid, pureed, and solid stages according to routine clinical practice.
实验性的：TRE + Standard Nutrition Therapy

Participants without an intragastric balloon who follow time-restricted eating (TRE; 16-hour daily fast, 8-hour eating window) in addition to standard energy-restricted nutrition therapy.
行为的：Standard Hypocaloric Nutrition Therapy

Individualized balanced diet with approximately 25% energy restriction from the estimated daily energy requirement (typically 1000 to 1400 kcal/day; protein 1.0 to 1.5 g/kg/day, carbohydrate 35 to 50% and fat 25 to 35% of energy), with regular dietitian follow-up, behavioral education, and advice to walk 7,500 to 10,000 steps per day.

行为的：Time-Restricted Eating (16:8)

Daily food intake limited to an 8-hour eating window with a 16-hour fast. The recommended fasting period is 18:00 to 10:00; alternative 16-hour periods (such as 19:00 to 11:00 or 20:00 to 12:00) are allowed. Water and non-caloric beverages are permitted during the fasting period. Energy and macronutrient targets are identical to standard nutrition therapy. Duration: 6 weeks.
实验性的：IGB + TRE + Standard Nutrition Therapy

Participants with an intragastric balloon (IGB) placed as part of routine clinical care who follow time-restricted eating (TRE; 16-hour daily fast, 8-hour eating window) in addition to standard energy-restricted nutrition therapy.
行为的：Standard Hypocaloric Nutrition Therapy

Individualized balanced diet with approximately 25% energy restriction from the estimated daily energy requirement (typically 1000 to 1400 kcal/day; protein 1.0 to 1.5 g/kg/day, carbohydrate 35 to 50% and fat 25 to 35% of energy), with regular dietitian follow-up, behavioral education, and advice to walk 7,500 to 10,000 steps per day.

设备：Intragastric Balloon

Endoscopically placed intragastric balloon, performed as part of routine clinical care based on physician indication and patient preference; placement is not assigned by the study. Diet after placement progresses through clear liquid, full liquid, pureed, and solid stages according to routine clinical practice.

行为的：Time-Restricted Eating (16:8)

Daily food intake limited to an 8-hour eating window with a 16-hour fast. The recommended fasting period is 18:00 to 10:00; alternative 16-hour periods (such as 19:00 to 11:00 or 20:00 to 12:00) are allowed. Water and non-caloric beverages are permitted during the fasting period. Energy and macronutrient targets are identical to standard nutrition therapy. Duration: 6 weeks.

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
Body weight
大体时间：Baseline, Month 3, Month 6

Kilograms, measured in light clothing without shoes (Tanita MC-780 MA)
Baseline, Month 3, Month 6
Body mass index
大体时间：Baseline, Month 3, Month 6

Weight and height combined to report BMI in kg/m²
Baseline, Month 3, Month 6
Percent total weight loss
大体时间：Month 3, Month 6

(Baseline weight - follow-up weight) / baseline weight × 100.
Month 3, Month 6
Percent excess weight loss
大体时间：Month 3, Month 6

(Baseline weight - follow-up weight) / (baseline weight - ideal weight) × 100; ideal weight at BMI 25 kg/m².
Month 3, Month 6
Fat mass
大体时间：Baseline, Month 3, Month 6

Kilograms, by multi-frequency bioelectrical impedance analysis
Baseline, Month 3, Month 6
Body fat percentage
大体时间：Baseline, Month 3, Month 6

Percent of body weight, by bioelectrical impedance analysis
Baseline, Month 3, Month 6
Muscle mass percentage
大体时间：Baseline, Month 3, Month 6

Percent of body weight, by bioelectrical impedance analysis
Baseline, Month 3, Month 6
Muscle mass
大体时间：Baseline, Month 3, Month 6

Kilograms, by bioelectrical impedance analysis
Baseline, Month 3, Month 6

次要结果测量

结果测量
措施说明
大体时间
Fasting plasma glucose
大体时间：Baseline, Month 6

Concentration in mg/dL from routine clinical laboratory results
Baseline, Month 6
fasting insulin (µIU/mL)
大体时间：Baseline, Month 6

Fasting serum insulin concentration in µIU/mL, obtained from routine clinical laboratory results.
Baseline, Month 6
Glycated Hemoglobin (HbA1c)
大体时间：Baseline, Month 6

Glycated hemoglobin (HbA1c) as a percentage of total hemoglobin, obtained from routine clinical laboratory results.
Baseline, Month 6
Total Cholesterol
大体时间：Baseline and Month 6

Serum total cholesterol concentration in mg/dL, obtained from routine clinical laboratory results.
Baseline and Month 6
High-Density Lipoprotein (HDL) Cholesterol
大体时间：Baseline and Month 6

Serum HDL cholesterol concentration in mg/dL, obtained from routine clinical laboratory results.
Baseline and Month 6
Triglycerides
大体时间：Baseline and Month 6

Serum triglyceride concentration in mg/dL, obtained from routine clinical laboratory results.
Baseline and Month 6
Alanine Aminotransferase (ALT)
大体时间：Baseline and Month 6

Serum ALT activity in U/L, obtained from routine clinical laboratory results
Baseline and Month 6
Aspartate Aminotransferase (AST)
大体时间：Baseline and Month 6

Serum AST activity in U/L, obtained from routine clinical laboratory results.
Baseline and Month 6
Serum Iron
大体时间：Baseline and Month 6

Serum iron concentration in µg/dL, obtained from routine clinical laboratory results.
Baseline and Month 6
Ferritin
大体时间：Baseline and Month 6

Serum ferritin concentration in ng/mL, obtained from routine clinical laboratory results.
Baseline and Month 6
Vitamin B12
大体时间：Baseline and Month 6

Serum vitamin B12 concentration in pg/mL, obtained from routine clinical laboratory results.
Baseline and Month 6
Folate
大体时间：Baseline and Month 6

Serum folate concentration in ng/mL, obtained from routine clinical laboratory results.
Baseline and Month 6
Sodium
大体时间：Baseline and Month 6

Serum sodium concentration in mmol/L, obtained from routine clinical laboratory results.
Baseline and Month 6
Potassium
大体时间：Baseline and Month 6

Serum potassium concentration in mmol/L, obtained from routine clinical laboratory results.
Baseline and Month 6
Daily energy intake
大体时间：Baseline and Month 6

Mean daily energy intake in kcal/day, calculated from a 3-day food record.
Baseline and Month 6
Daily Protein Intake
大体时间：Baseline and Month 6

Mean daily protein intake in g/day, calculated from a 3-day food record.
Baseline and Month 6
Daily Carbohydrate Intake
大体时间：Baseline and Month 6

Mean daily carbohydrate intake in g/day, calculated from a 3-day food record.
Baseline and Month 6
Daily Fat Intake
大体时间：Baseline and Month 6

Mean daily fat intake in g/day, calculated from a 3-day food record.
Baseline and Month 6
Daily Step Count
大体时间：Baseline and Month 6

Mean number of steps per day, reported by participants from their smartphone step counter.
Baseline and Month 6

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。

赞助

Mudanya University

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5月12日

初级完成 (估计的)

2026年11月15日

研究完成 (估计的)

2026年12月1日

研究注册日期

首次提交

2026年11月7日

首先提交符合 QC 标准的

2026年11月7日

首次发布 (实际的)

2026年11月13日

研究记录更新

最后更新发布 (实际的)

2026年11月13日

上次提交的符合 QC 标准的更新

2026年11月7日

最后验证

2026年11月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • MUDU-SBE-SS-06

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

In accordance with the study protocol approved by the ethics committee and national data protection legislation (Law No. 6698 on the Protection of Personal Data), individual participant data will be accessible only to the research team and will not be shared with third parties. Aggregate results will be published in peer-reviewed journals.

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.

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