The Effect of Intermittent Fasting Variations on Nutrigenomic Profile, Changes in Metabolic and Inflammatory Parameters, and Body Composition in Patients With Prediabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Metabolic Profile
研究概览
简要总结
Prediabetes is a metabolic condition associated with increased risk of type 2 diabetes and cardiovascular disease. Intermittent fasting (IF) has emerged as a potential dietary intervention to improve metabolic health, yet comparative evidence among different IF patterns remains limited.
This randomized controlled trial aims to evaluate the effects of three intermittent fasting regimens-5:2 fasting, alternate-day fasting, and time-restricted feeding-compared with a control diet on metabolic parameters, inflammatory markers, body composition, and nutrigenomic profiles in adults with prediabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with prediabetes, defined according to ADA criteria (fasting plasma glucose 100-125 mg/dL or 2-hour postprandial glucose 140-199 mg/dL).
- •Willing to follow the fasting/diet intervention protocol for 4-6 weeks (depending on the study duration).
- •Signing informed consent and willing to be randomized into one of 3 intervention groups (Monday-Thursday Fasting/5:2, Alternate-Day Fasting/ADF, or Time-Restricted Fasting/IF).
排除标准
- •Diagnosis of type 2 diabetes mellitus.
- •Currently undergoing antidiabetic drug therapy (e.g., metformin, sulfonylurea, insulin).
- •Has a severe chronic disease (kidney failure, liver failure, heart failure, or eating disorder).
- •Pregnancy or breastfeeding.
- •History of eating disorders (anorexia nervosa, bulimia nervosa, or binge eating disorder).
- •Taking medications that affect glucose metabolism (e.g., systemic steroids, atypical antipsychotics, etc.). Diagnosis of type 2 diabetes
研究组 & 干预措施
Intermittent Fasting (16:8)
干预措施: Diet (Behavioral)
5:2 Diet
干预措施: Diet (Behavioral)
Non Fasting
结局指标
主要结局
Metabolic Profile
时间窗: Baseline, Week 3, and Week 6
Change in Fasting Plasma Glucose (mg/dL)
次要结局
- Lipid Profile(Baseline and Week 6)
- Nutrigenomics(Baseline)
- Body Composition(Baseline, Week 3, and Week 6)
- Inflammation Profile(Baseline and Week 6)
研究者
DINA KEUMALA SARI
Prof
Universitas Sumatera Utara