Intragastric Balloon and Time-Restricted Eating for Weight Loss in Adults With Overweight or Obesity
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.
Přehled studie
Postavení
Podmínky
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Seher Şen, Assistant Professor
- Telefonní číslo: 05393919700
- E-mail: seherdalli@gmail.com
Studijní místa
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Yıldırım
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Bursa, Yıldırım, Turecko (Türkiye)
- Nábor
- Yıldırım Doruk Hastanesi
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Kontakt:
- Yıldırım Doruk Hastanesi Seher ŞEN, Assistant Professor
- Telefonní číslo: 05393919700
- E-mail: seher.sen@mudanya.edu.tr
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-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Nerandomizované
- Intervenční model: Faktorové přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Aktivní komparátor: Standard Nutrition Therapy
Participants without an intragastric balloon who receive standard energy-restricted nutrition therapy only. |
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. |
|
Aktivní komparátor: IGB + Standard Nutrition Therapy
Participants with an intragastric balloon (IGB) placed as part of routine clinical care who receive standard energy-restricted 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. 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. |
|
Experimentální: 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. |
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. 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. |
|
Experimentální: 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. |
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. 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. 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. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Body weight
Časové okno: Baseline, Month 3, Month 6
|
Kilograms, measured in light clothing without shoes (Tanita MC-780 MA) |
Baseline, Month 3, Month 6
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Body mass index
Časové okno: Baseline, Month 3, Month 6
|
Weight and height combined to report BMI in kg/m² |
Baseline, Month 3, Month 6
|
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Percent total weight loss
Časové okno: Month 3, Month 6
|
(Baseline weight - follow-up weight) / baseline weight × 100. |
Month 3, Month 6
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Percent excess weight loss
Časové okno: Month 3, Month 6
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(Baseline weight - follow-up weight) / (baseline weight - ideal weight) × 100; ideal weight at BMI 25 kg/m². |
Month 3, Month 6
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Fat mass
Časové okno: Baseline, Month 3, Month 6
|
Kilograms, by multi-frequency bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
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Body fat percentage
Časové okno: Baseline, Month 3, Month 6
|
Percent of body weight, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
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Muscle mass percentage
Časové okno: Baseline, Month 3, Month 6
|
Percent of body weight, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
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Muscle mass
Časové okno: Baseline, Month 3, Month 6
|
Kilograms, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Fasting plasma glucose
Časové okno: Baseline, Month 6
|
Concentration in mg/dL from routine clinical laboratory results |
Baseline, Month 6
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fasting insulin (µIU/mL)
Časové okno: Baseline, Month 6
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Fasting serum insulin concentration in µIU/mL, obtained from routine clinical laboratory results. |
Baseline, Month 6
|
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Glycated Hemoglobin (HbA1c)
Časové okno: Baseline, Month 6
|
Glycated hemoglobin (HbA1c) as a percentage of total hemoglobin, obtained from routine clinical laboratory results. |
Baseline, Month 6
|
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Total Cholesterol
Časové okno: Baseline and Month 6
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Serum total cholesterol concentration in mg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
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High-Density Lipoprotein (HDL) Cholesterol
Časové okno: Baseline and Month 6
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Serum HDL cholesterol concentration in mg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Triglycerides
Časové okno: Baseline and Month 6
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Serum triglyceride concentration in mg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Alanine Aminotransferase (ALT)
Časové okno: Baseline and Month 6
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Serum ALT activity in U/L, obtained from routine clinical laboratory results |
Baseline and Month 6
|
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Aspartate Aminotransferase (AST)
Časové okno: Baseline and Month 6
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Serum AST activity in U/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Serum Iron
Časové okno: Baseline and Month 6
|
Serum iron concentration in µg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
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Ferritin
Časové okno: Baseline and Month 6
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Serum ferritin concentration in ng/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
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Vitamin B12
Časové okno: Baseline and Month 6
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Serum vitamin B12 concentration in pg/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Folate
Časové okno: Baseline and Month 6
|
Serum folate concentration in ng/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Sodium
Časové okno: Baseline and Month 6
|
Serum sodium concentration in mmol/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Potassium
Časové okno: Baseline and Month 6
|
Serum potassium concentration in mmol/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
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Daily energy intake
Časové okno: Baseline and Month 6
|
Mean daily energy intake in kcal/day, calculated from a 3-day food record. |
Baseline and Month 6
|
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Daily Protein Intake
Časové okno: Baseline and Month 6
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Mean daily protein intake in g/day, calculated from a 3-day food record. |
Baseline and Month 6
|
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Daily Carbohydrate Intake
Časové okno: Baseline and Month 6
|
Mean daily carbohydrate intake in g/day, calculated from a 3-day food record. |
Baseline and Month 6
|
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Daily Fat Intake
Časové okno: Baseline and Month 6
|
Mean daily fat intake in g/day, calculated from a 3-day food record. |
Baseline and Month 6
|
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Daily Step Count
Časové okno: Baseline and Month 6
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Mean number of steps per day, reported by participants from their smartphone step counter. |
Baseline and Month 6
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Spolupracovníci a vyšetřovatelé
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- MUDU-SBE-SS-06
Plán pro data jednotlivých účastníků (IPD)
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Popis plánu IPD
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.
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