Comparison of Time-Restricted Intermittent Fasting Diet in Individuals With and Without Bariatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Body Weight
研究概览
简要总结
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).
详细描述
Obesity remains a major global health concern, with bariatric surgery (BS) being the most effective treatment for severe obesity. However, some patients experience insufficient weight loss (IWL) or weight regain (WR) approximately 18 months after surgery, which is associated with recurrence of obesity-related comorbidities and reduced quality of life.
Time-restricted eating (TRE), a form of intermittent fasting, has emerged as a promising dietary approach for obesity management. The 16/8 TRE model, which limits food intake to an 8-hour window, has shown beneficial effects on body weight, insulin resistance, glycemic control, and lipid profiles in non-surgical individuals with obesity. However, evidence regarding its efficacy and safety in post-bariatric surgery patients remains limited.
This prospective controlled study will enroll 40 adults with obesity (20 per group): Group 1 - adults with obesity who have not undergone BS; Group 2 - adults with IWL or WR following BS. All participants will follow a 16:8 TRE protocol for 6 weeks, with nutritional principles aligned with ASMBS guidelines. Follow-up visits will be conducted face-to-face at baseline, day 15, day 30, and day 45, with additional weekly contact via phone or WhatsApp. Anthropometric measurements will be assessed at baseline and at week 6. Dietary intake will be evaluated using 3-day food records and food frequency questionnaires, analyzed with the BEBİS-9 nutrition software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm 1: Adults with Obesity (Non-Bariatric)
Adults with obesity who have not undergone bariatric surgery. Will follow 16:8 TRE protocol for 6 weeks.
干预措施: Time-Restricted Eating (16:8) (Behavioral)
Arm 2: Adults with Obesity (Post-Bariatric)
Adults with obesity who experienced insufficient weight loss or weight regain following bariatric surgery. Will follow 16:8 TRE protocol for 6 weeks.
干预措施: Time-Restricted Eating (16:8) (Behavioral)
结局指标
主要结局
Body Weight
时间窗: Baseline and 6 weeks
Change in body weight measured by digital scale
Body Mass Index (BMI)
时间窗: Baseline and 6 weeks
Change in BMI calculated as weight (kg) divided by height squared (m²)
Body Fat Mass
时间窗: Baseline and 6 weeks
Change in fat mass assessed by bioelectrical impedance analysis (Tanita MC-780 MA)
Muscle Mass
时间窗: Baseline and 6 weeks
Change in muscle mass assessed by bioelectrical impedance analysis (Tanita MC-780 MA)
Waist Circumference
时间窗: Baseline and 6 weeks
Change in waist circumference measured at 5 cm below the navel
Hip Circumference
时间窗: Baseline and 6 weeks
Change in hip circumference measured at the maximum point of gluteal muscles
Percentage of Excess Weight Loss (%EWL)
时间窗: 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)
时间窗: 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.
次要结局
- Daily Energy Intake(Baseline and 6 weeks)
- Dietary Macronutrient Distribution(Baseline and 6 weeks)
研究者
Seher Şen
Assist. Prof. Dr.
Mudanya University