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.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Seher Şen, Assistant Professor
- Numero di telefono: 05393919700
- Email: seherdalli@gmail.com
Luoghi di studio
-
-
Yıldırım
-
Bursa, Yıldırım, Turchia (Türkiye)
- Reclutamento
- Yıldırım Doruk Hastanesi
-
Contatto:
- Yıldırım Doruk Hastanesi Seher ŞEN, Assistant Professor
- Numero di telefono: 05393919700
- Email: seher.sen@mudanya.edu.tr
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione fattoriale
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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. |
|
Comparatore attivo: 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. |
|
Sperimentale: 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. |
|
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Body weight
Lasso di tempo: Baseline, Month 3, Month 6
|
Kilograms, measured in light clothing without shoes (Tanita MC-780 MA) |
Baseline, Month 3, Month 6
|
|
Body mass index
Lasso di tempo: Baseline, Month 3, Month 6
|
Weight and height combined to report BMI in kg/m² |
Baseline, Month 3, Month 6
|
|
Percent total weight loss
Lasso di tempo: Month 3, Month 6
|
(Baseline weight - follow-up weight) / baseline weight × 100. |
Month 3, Month 6
|
|
Percent excess weight loss
Lasso di tempo: 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
Lasso di tempo: Baseline, Month 3, Month 6
|
Kilograms, by multi-frequency bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
|
Body fat percentage
Lasso di tempo: Baseline, Month 3, Month 6
|
Percent of body weight, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
|
Muscle mass percentage
Lasso di tempo: Baseline, Month 3, Month 6
|
Percent of body weight, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
|
Muscle mass
Lasso di tempo: Baseline, Month 3, Month 6
|
Kilograms, by bioelectrical impedance analysis |
Baseline, Month 3, Month 6
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Fasting plasma glucose
Lasso di tempo: Baseline, Month 6
|
Concentration in mg/dL from routine clinical laboratory results |
Baseline, Month 6
|
|
fasting insulin (µIU/mL)
Lasso di tempo: Baseline, Month 6
|
Fasting serum insulin concentration in µIU/mL, obtained from routine clinical laboratory results. |
Baseline, Month 6
|
|
Glycated Hemoglobin (HbA1c)
Lasso di tempo: Baseline, Month 6
|
Glycated hemoglobin (HbA1c) as a percentage of total hemoglobin, obtained from routine clinical laboratory results. |
Baseline, Month 6
|
|
Total Cholesterol
Lasso di tempo: 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
Lasso di tempo: Baseline and Month 6
|
Serum HDL cholesterol concentration in mg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Triglycerides
Lasso di tempo: Baseline and Month 6
|
Serum triglyceride concentration in mg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Alanine Aminotransferase (ALT)
Lasso di tempo: Baseline and Month 6
|
Serum ALT activity in U/L, obtained from routine clinical laboratory results |
Baseline and Month 6
|
|
Aspartate Aminotransferase (AST)
Lasso di tempo: Baseline and Month 6
|
Serum AST activity in U/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Serum Iron
Lasso di tempo: Baseline and Month 6
|
Serum iron concentration in µg/dL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Ferritin
Lasso di tempo: Baseline and Month 6
|
Serum ferritin concentration in ng/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Vitamin B12
Lasso di tempo: Baseline and Month 6
|
Serum vitamin B12 concentration in pg/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Folate
Lasso di tempo: Baseline and Month 6
|
Serum folate concentration in ng/mL, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Sodium
Lasso di tempo: Baseline and Month 6
|
Serum sodium concentration in mmol/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Potassium
Lasso di tempo: Baseline and Month 6
|
Serum potassium concentration in mmol/L, obtained from routine clinical laboratory results. |
Baseline and Month 6
|
|
Daily energy intake
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Baseline and Month 6
|
Mean number of steps per day, reported by participants from their smartphone step counter. |
Baseline and Month 6
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- MUDU-SBE-SS-06
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano 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.
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .