NCT07289880尚未招募不适用
Efficacy of Diacylglycerol Oil on Metabolic Risk Factors in Prediabetes
The First Affiliated Hospital of Guangdong Pharmaceutical University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年12月30日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Continuous Glucose Monitoring (CGM) Data
研究概览
简要总结
This study will implement a four-week dietary intervention among middle-aged and older adults with pre-diabetes. Participants assigned to the intervention arm will replace their usual cooking oil with diacylglycerol (DAG) oil, while those in the control arm will consume colza oil. All other lifestyle behaviors will be maintained without modification. The trial will determine the impact of DAG oil consumption on glycemic regulation, lipid metabolism, and body composition in this high-risk population.
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
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 40-75 years.
- •Diagnosed with prediabetes according to American Diabetes Association (ADA) criteria: including fasting plasma glucose (FPG) levels of 5.6-6.9 mmol/L, and/or 2-hour postprandial glucose (OGTT-2h) levels of 7.8-11.1 mmol/L, and/or glycated hemoglobin (HbA1c) levels of 5.7%-6.4%.
- •Body mass index (BMI) ≥ 24 kg/m².
- •No plans to relocate or travel extensively in the next three months.
- •Willing to consume all study-provided meals throughout the intervention.
- •Willing and able to provide written informed consent.
排除标准
- •Diagnosis of diabetes (Type 1 or Type 2).
- •Current use of any glucose-lowering medication.
- •Use of appetite suppressants or hormonal medications.
- •History of bariatric surgery, or weight change >5% in the past 3 months.
- •Alcohol consumption >40 g/day.
- •Use of antibiotics, probiotics, or prebiotics within the past 3 months.
- •Pregnancy, lactation or planning pregnancy.
- •History of severe cardiovascular disease, malignancy, autoimmune disease, cognitive impairment, or severe dysfunction of thyroid, liver, kidney, or digestive system.
- •Inability to comprehend information, communicate effectively, or comply with the study protocol.
结局指标
主要结局
Continuous Glucose Monitoring (CGM) Data
时间窗: up to 4 weeks
At baseline, and 4 weeks, investigators will using Continuous Glucose Monitoring (CGM) to monitor the glucose level of participants.
次要结局
- weight(up to 4 weeks)
- fasting blood glucose(At baseline and after 4 weeks of intervention)
- lipid metabolism(At baseline and after 4 weeks of intervention)
- HbA1c(At baseline and after 4 weeks of intervention)
- intestinal bacteria(up to 4 weeks)
- TIR (time in range)(At baseline and after 4 weeks of intervention)
- sleep quality(up to 4 weeks)
- blood pressure(up to 4 weeks)
- weight(up to 4 weeks)
- fasting blood glucose(At baseline and after 4 weeks of intervention)
- lipid metabolism(At baseline and after 4 weeks of intervention)
- HbA1c(At baseline and after 4 weeks of intervention)
- intestinal bacteria(up to 4 weeks)
- TIR (time in range)(At baseline and after 4 weeks of intervention)
- sleep quality(up to 4 weeks)
- blood pressure(up to 4 weeks)
研究者
Qiu-ye Lan
Associate Researcher
Guangdong Pharmaceutical University
研究点 (1)
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