The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Serum of TNF-α, IL-1β and IL-6
研究概览
简要总结
Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks.
Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •IR individuals diagnosed with IR by the physicians as indicated by HOMA-IR score
- •female and male, BMI ≥ 30 to 39.9 kg/m2
- •age between 18 and 40 years
- •stable weight for 3 months before the beginning of the study
- •sedentary lifestyle
排除标准
- •previous weight loss surgery
- •pregnancy or intent to become pregnant
- •breastfeeding
- •chronic diseases
- •drug therapies that could interfere with the effectiveness of the dietary intervention (e.g., use of corticosteroids, and anti-diabetic drugs)
- •diabetic type 1 and 2 individuals
- •anyone physically active to reduce the influence of confounding covariates
研究组 & 干预措施
No time restricted eating - normal diet
干预措施: No time restricted eating - Normal diet (Other)
10-h Time restricted eating with caloric restriction
干预措施: time restricted eating with caloric restriction (Other)
10-h time restricted eating without caloric restriction
干预措施: time restricted eating without caloric restriction (Other)
caloric restriction without time restricted eating
干预措施: Caloric restriction without Time restricted eating (Other)
结局指标
主要结局
Serum of TNF-α, IL-1β and IL-6
时间窗: baseline and after 12 weeks of intervention
Will be measured using ELISA before and after dietary intervention to assess the impact of time restricted eating on these proinflammatory biomarkers in participants diagnosed with Insulin resistance
次要结局
- Homa-IR(baseline and after 12 weeks of intervention)
- Lipid profile (LDL, HDL, TG, and cholesterol)(baseline and after 12 weeks of intervention)
- body weight(baseline and every 2 weeks until 12 weeks of intervention)
- Dietary intake using food records(week4, week 8, and week 12 week)
- Fasting blood glucose(baseline and after 12 weeks of intervention)
- fasting insulin level(baseline and after 12 weeks of intervention)
- height(baseline)
- Body composition(baseline and every 2 weeks until 12 weeks of intervention)
研究者
Najd AlSarayreh
Principal investigator, PhD Candidate in Human Nutrition and Dietetics
University of Jordan