An interventional study of Standard Hypocaloric Nutrition Therapy and Time-Restricted Eating (16:8) in Obesity; Overweight, sponsored by Mudanya University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-13.
Sponsored by Mudanya University · Not applicable, Interventional, and Treatment
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Among 353 studies in Obesity with a site in Turkey — 73 open to participants now, 91 under way, 16 of them phase 3. Obesity · Turkey.
Among the 353 studies in Obesity with a site in Turkey, this one is the 100th largest by planned enrollment of the 192 interventional ones that give a count, is one of 60 that started in 2026, is one of 161 with no phase, reaches primary completion later than 41 of the 90 other live ones, and was the 353rd registered.
11,529 studies on the registry are indexed under Obesity; 2,035 are open to participants now.
Browse Obesity studies →73 of the 353 studies in Obesity with a site in Turkey are open now. Recruiting first, the newest first:
Pamukkale University · Sites in Turkey
Ages 18–65 · Women only
Gazi University · Sites in Turkey
Ages 50–60 · Women only
Duzce University · Sites in Turkey
Ages 18+
Pamukkale University · Sites in Turkey
Ages 18–60 · Women only
Kocaeli University · Sites in Turkey
Ages 18–65 · Healthy volunteers
A study can be open while its sites in Turkey have not opened yet or have stopped. Only those recruiting at a site in Turkey →
Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 166 take children under 18; 488 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
353 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 3 · Phase 3 27 · Phase 4 3
First in 2005; this study’s year is marked. 60 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 60 is below the median of 67 across 9,010 interventional studies indexed under Obesity.
Median enrollment 64 across the 192 interventional studies, 82 across the 160 observational. Of the 236 that completed or were terminated, 7 (3%) have results posted.
This tab as a report to print or save as PDF → With an account.
34 of 353 have an industry lead sponsor. The 10 most frequent:
Mudanya University is the lead sponsor of 3 studies on the registry; 3 are open to participants now.
Mudanya University has 2 studies filed under Obesity — fewer than ten, so there is no comparison to draw.
35 of the studies in Obesity with a site in Turkey that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05556512Phase 3Eli Lilly and CompanyA Study of Tirzepatide (LY3298176) on the Reduction on Morbidity and Mortality in Adults With Obesity | 2027-10 |
| NCT07769736Istinye UniversityMotivational Interviews Based on the Five-Step (5A) Model on Obesity Risk | 2026-11 |
| NCT07652151Fundación Pública Andaluza para la gestión de la Investigación en SevillaUNMASK: Unveiling the Pathobiology of Metabolic Dysfunction-Associated Steatotic Liver Disease for the Discovery of Novel Therapeutics and Biomarkers | 2026-11 |
| NCT07936877Mudanya UniversityIntragastric Balloon and Time-Restricted Eating for Weight Loss in Adults With Overweight or Obesity | 2026-11-15 |
| NCT07878299Sultan Abdulhamid Han Training and Research Hospital, Istanbul, TurkeyComparison of Segmental Body Composition Characteristics in Lipedema and Obesity | 2026-11-20 |
Add all 35 to your calendar (.ics) → With an account.
Among the 353 studies in Obesity with a site in Turkey, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants without an intragastric balloon who receive standard energy-restricted nutrition therapy only.
Behavioral: Standard Hypocaloric Nutrition Therapy
Participants with an intragastric balloon (IGB) placed as part of routine clinical care who receive standard energy-restricted nutrition therapy.
Behavioral: Standard Hypocaloric Nutrition Therapy · Device: Intragastric Balloon
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.
Behavioral: Standard Hypocaloric Nutrition Therapy · Behavioral: Time-Restricted Eating (16:8)
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.
Behavioral: Standard Hypocaloric Nutrition Therapy · Behavioral: Time-Restricted Eating (16:8) · Device: Intragastric Balloon
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.
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.
Body weight
Kilograms, measured in light clothing without shoes (Tanita MC-780 MA)
Time frame: Baseline, Month 3, Month 6
Body mass index
Weight and height combined to report BMI in kg/m²
Time frame: Baseline, Month 3, Month 6
Percent total weight loss
(Baseline weight - follow-up weight) / baseline weight × 100.
Time frame: Month 3, Month 6
Percent excess weight loss
(Baseline weight - follow-up weight) / (baseline weight - ideal weight) × 100; ideal weight at BMI 25 kg/m².
Time frame: Month 3, Month 6
Fat mass
Kilograms, by multi-frequency bioelectrical impedance analysis
Time frame: Baseline, Month 3, Month 6
Body fat percentage
Percent of body weight, by bioelectrical impedance analysis
Time frame: Baseline, Month 3, Month 6
Muscle mass percentage
Percent of body weight, by bioelectrical impedance analysis
Time frame: Baseline, Month 3, Month 6
Muscle mass
Kilograms, by bioelectrical impedance analysis
Time frame: Baseline, Month 3, Month 6
Fasting plasma glucose
Concentration in mg/dL from routine clinical laboratory results
Time frame: Baseline, Month 6
fasting insulin (µIU/mL)
Fasting serum insulin concentration in µIU/mL, obtained from routine clinical laboratory results.
Time frame: Baseline, Month 6
Glycated Hemoglobin (HbA1c)
Glycated hemoglobin (HbA1c) as a percentage of total hemoglobin, obtained from routine clinical laboratory results.
Time frame: Baseline, Month 6
Total Cholesterol
Serum total cholesterol concentration in mg/dL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
High-Density Lipoprotein (HDL) Cholesterol
Serum HDL cholesterol concentration in mg/dL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Triglycerides
Serum triglyceride concentration in mg/dL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Alanine Aminotransferase (ALT)
Serum ALT activity in U/L, obtained from routine clinical laboratory results
Time frame: Baseline and Month 6
Aspartate Aminotransferase (AST)
Serum AST activity in U/L, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Serum Iron
Serum iron concentration in µg/dL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Ferritin
Serum ferritin concentration in ng/mL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Vitamin B12
Serum vitamin B12 concentration in pg/mL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Folate
Serum folate concentration in ng/mL, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Sodium
Serum sodium concentration in mmol/L, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Potassium
Serum potassium concentration in mmol/L, obtained from routine clinical laboratory results.
Time frame: Baseline and Month 6
Daily energy intake
Mean daily energy intake in kcal/day, calculated from a 3-day food record.
Time frame: Baseline and Month 6
Daily Protein Intake
Mean daily protein intake in g/day, calculated from a 3-day food record.
Time frame: Baseline and Month 6
Daily Carbohydrate Intake
Mean daily carbohydrate intake in g/day, calculated from a 3-day food record.
Time frame: Baseline and Month 6
Daily Fat Intake
Mean daily fat intake in g/day, calculated from a 3-day food record.
Time frame: Baseline and Month 6
Daily Step Count
Mean number of steps per day, reported by participants from their smartphone step counter.
Time frame: Baseline and Month 6
Plan to share: No — 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.
No publications or documents are linked to this record.
Started May 2026 (actual). Primary completion is estimated for Nov 2026, 6 months after the start.
Of 3,683 non-industry interventional studies with no phase under Obesity, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 43. This study's planned 6 months is below that.
Counting every sponsor, half of 3,846 studies reached it within 22 months; a quarter within 9 and three quarters within 42.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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