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

7 november 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

60

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
    • Yıldırım
      • Bursa, Yıldırım, Turkije (Türkiye)
        • Werving
        • Yıldırım Doruk Hastanesi
        • Contact:
          • Yıldırım Doruk Hastanesi Seher ŞEN, Assistant Professor
          • Telefoonnummer: 05393919700
          • E-mail: seher.sen@mudanya.edu.tr

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Faculteitstoewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Standard Nutrition Therapy

Participants without an intragastric balloon who receive standard energy-restricted nutrition therapy only.
Gedragsmatig: 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.
Actieve vergelijker: IGB + Standard Nutrition Therapy

Participants with an intragastric balloon (IGB) placed as part of routine clinical care who receive standard energy-restricted nutrition therapy.
Gedragsmatig: 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.

Apparaat: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Gedragsmatig: 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.
Experimenteel: 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.
Gedragsmatig: 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.

Apparaat: 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.

Gedragsmatig: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Body weight
Tijdsspanne: Baseline, Month 3, Month 6

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

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

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

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

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

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

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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Fasting plasma glucose
Tijdsspanne: Baseline, Month 6

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Mudanya University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 mei 2026

Primaire voltooiing (Geschat)

15 november 2026

Studie voltooiing (Geschat)

1 december 2026

Studieregistratiedata

Eerst ingediend

7 november 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 november 2026

Eerst geplaatst (Werkelijk)

13 november 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 november 2026

Laatste update ingediend die voldeed aan QC-criteria

7 november 2026

Laatst geverifieerd

1 november 2026

Meer informatie

Termen gerelateerd aan deze studie

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • MUDU-SBE-SS-06

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

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.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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