Clinical trial

Time-Restricted Eating After Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT07672821

Recruiting nowNot applicableInterventional

What this study is about

This study aims to compare the effects of time-restricted eating (TRE, 16/8) in adults with obesity who have and have not undergone bariatric surgery (BS). The study will include adults aged 18-65 years: those with obesity who have not undergone BS, and those who have experienced insufficient weight loss (IWL) or weight regain (WR) following BS. Both groups will follow a 16:8 time-restricted eating protocol for 6 weeks, with an 8-hour eating window recommended between 10:00 AM and 6:00 PM, though participants may adjust to other 16-hour fasting windows. Participants will be evaluated before and after the intervention in terms of anthropometric measurements, biochemical parameters, and dietary habits. The study is being conducted at a private hospital in Bursa, Turkey, and is planned to be completed with a total of 40 participants (20 per group).

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity & Overweight, Bariatric Surgery, Weight Regain, Weight Regain Post Bariatric Surgery, Time Restricted Feeding

Full registry criteria

Inclusion Criteria: * Adults aged 18-65 years with obesity who have not undergone bariatric surgery * Adults aged 18-65 years with obesity who have undergone bariatric surgery and experienced insufficient weight loss (IWL) within 18 months post-surgery, -defined as %EWL \<50% at 18 months * Adults aged 18-65 years with obesity who have undergone bariatric surgery and experienced weight regain (WR), defined as \>25% increase in %EWL from the lowest recorded weight Exclusion Criteria: * Pregnant or breastfeeding individuals * Acute illness, active infection, or comorbid conditions limiting treatment efficacy and safety, including: cancer, type 1 diabetes, renal or hepatic failure, recent stroke or myocardial infarction, nephrolithiasis, drug or alcohol abuse, eating disorders, severe depression or other psychiatric disorders, inflammatory bowel disease (IBD), neoplasia, arrhythmic heart disease, heart failure, respiratory failure, or corticosteroid therapy * Professional athletes

Treatments and study arms

Time-Restricted Eating (16:8)

Behavioral

Participants will follow a 16:8 time-restricted eating protocol for 6 weeks, limiting food intake to an 8-hour window (recommended 10:00 AM-6:00 PM, with flexibility to adjust). During the 16-hour fasting period, only water and non-caloric beverages (tea, coffee, soda) are permitted. Nutritional principles will be aligned with ASMBS guidelines.

Primary outcomes

Body WeightBaseline and 6 weeks

Change in body weight measured by digital scale

Body Mass Index (BMI)Baseline and 6 weeks

Change in BMI calculated as weight (kg) divided by height squared (m²)

Body Fat MassBaseline and 6 weeks

Change in fat mass assessed by bioelectrical impedance analysis (Tanita MC-780 MA)

Muscle MassBaseline and 6 weeks

Change in muscle mass assessed by bioelectrical impedance analysis (Tanita MC-780 MA)

Waist CircumferenceBaseline and 6 weeks

Change in waist circumference measured at 5 cm below the navel

Hip CircumferenceBaseline and 6 weeks

Change in hip circumference measured at the maximum point of gluteal muscles

Percentage of Excess Weight Loss (%EWL)Baseline and 6 weeks

Calculated as: \[(preoperative weight - postoperative weight) / (preoperative weight - ideal weight)\] × 100. Ideal body weight defined based on a BMI of 25 kg/m². Insufficient weight loss (IWL) defined as

Percentage of Total Weight Loss (%TWL)Baseline and 6 weeks

Calculated as: \[(preoperative weight - postoperative weight) / preoperative weight\] × 100. Used to assess overall weight loss outcomes in both bariatric and non-bariatric participants following the 6-week time-restricted eating intervention.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Nev Sağlık Grubu🌐 Bursa, Lütfen Seçiniz., Turkey (Türkiye)

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Study contactContact

Nev Sağlık Grubu🌐 Bursa, Turkey (Türkiye)

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Nev Sağlık Grubu dallı Seher ŞEN, Assistant ProfessorContact

Email · Call 05393919700