The Effect of Ketogenic-Caloric Restricted Dietary Intervention on Metabolic Endotoxemia Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Serum Lipopolysaccharides (LPS) Levels
研究概览
简要总结
Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited.
This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Males and females individuals aged 18-40 years
- •Individuals with a body mass index (BMI) greater than 30 kg/m² and less than 40 kg/m².
- •Individuals medically diagnosed with prediabetes by a physician prior to enrollment in the study as indicated by hemoglobin A1c (HbA1c) levels between 5.7% and 6.4% (American Diabetes Association, 2024), or HOMA-IR score of greater than 1.
- •Individuals demonstrating a willingness to follow the dietary protocol
- •Individuals engaging in sedentary physical activity levels
排除标准
- •Individuals diagnosed with any other chronic disease or type 1 and type 2 diabetes mellitus.
- •Individuals have experienced weight loss of more than 5% in the last three months.
- •Pregnant or lactating women.
- •Individuals undergoing any form of drug treatment.
- •Individuals with a history of major surgery.
- •Individuals have consumed pro-/pre/symbiotic or antibiotics in the past three months.
- •Individuals who engage in any form of regular sports activity.
研究组 & 干预措施
Ketogenic diet with caloric restriction
干预措施: Ketogenic diet with caloric restriction (Other)
Normal diet with caloric restriction
干预措施: Normal diet with caloric restriction (Other)
Normal diet without caloric restriction
干预措施: Normal diet without caloric restriction (Other)
结局指标
主要结局
Serum Lipopolysaccharides (LPS) Levels
时间窗: Baseline and after 12 weeks of intervention
Serum LPS levels will be measured using ELISA before and after the dietary intervention to assess the impact of ketogenic-caloric restricted diet on metabolic endotoxemia in adult participants with obesity and insulin resistance."
次要结局
- Ketone bodies(week 6 and after 12 weeks of intervention)
- TNF-α, IL-6 serum levels(Baseline and after 12 weeks of intervention)
- Change in Fasting Glucose Level(Baseline and after 12 weeks of intervention)
- Lipid Profile (Total Cholesterol, LDL, HDL, Triglycerides)(Baseline and after 12 weeks of intervention)
- Change in Body weight in kilograms(Baseline and every 2 weeks until week 12)
- Dietary Intake using Food Records(week4, week 8 and week 12)
- Change in Fasting Insulin Level(Baseline and after 12 weeks of intervention)
- Change in HOMA-IR Index(Baseline and after 12 weeks of intervention)
- Height in meters(Baseline only)
- Body fat percentage and lean body mass using bioelectrical impedance analysis (BIA)(Baseline and every 2 weeks until week 12)
- Body Mass Index (BMI) in kg/m²(Baseline and every 2 weeks until week 12)
研究者
Aseel Basem jawamis
Principal Investigator, PhD Candidate in Human Nutrition and Dietetics
University of Jordan