NCT07533513尚未招募不适用
Effects and Mechanisms of Dietary Carbohydrate Intake and Quality on Glucose and Lipid Metabolism
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年4月13日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glucose
研究概览
简要总结
This study aimed to explore the effects of quantity and quality of dietary carbohydrate intakes on glucose and lipid levels and metabolism, as well as gut microbiota by a randomized crossover controlled intervention trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Male and female aged 18 - 65 years;
- •BMI 20 - 35 kg/m2;
- •Consent to be randomly assigned to an intervention or control group;
- •Willingness to eat the food and beverages provided in the study;
- •Patients with or at high risk of metabolic syndrome, and the diagnostic criteria of metabolic syndrome were based on the Chinese Guidelines for the Prevention and Treatment of diabetes (2024 edition).
排除标准
- •Use of medications that affect blood glucose metabolism;
- •Familial hyperlipidemia, or use of drugs that affect lipid metabolism;
- •Long-term or current use of nonsteroidal anti-inflammatory drugs, antibiotics, antihistamines, or immunomodulatory drugs, and unable to stop taking these drugs within 72 h before the start of the study;
- •Use of hormonal medications such as anticoagulants, anabolic steroids, and hydrocortisone;
- •Have a history of serious illness, or are in the acute stage of cardiovascular, renal, thyroid, gastrointestinal, hepatobiliary, immunologic, respiratory, neurological, musculoskeletal, psychiatric, infectious, and malignant diseases, and are receiving treatment or use of related drugs;
- •Self-reported weight gain or loss of more than 7 kg in the 6 months before enrollment;
- •Vegetarian;
- •Have food allergies or other problems that may affect food intake;
- •Unable to consume only the food and beverages provided in the study;
- •Drink alcohol more than 2 times per day, more than 14 times per week, and unwillingness to stop drinking during the study;
- •Participate in a weight-loss program;
- •Unwillingness to maintain weight throughout the study;
- •Females who have given birth within the past year, are pregnant or plan to become pregnant within 6 months, are breastfeeding;
- •Intend to participate in other dietary intervention studies and drug use studies in the next 4 months;
- •Poor venous blood access;
- •Any other that the physician assessed as unsuitable for the trial conditions.
研究组 & 干预措施
High-carbohydrate high-GI diet
Other
干预措施: Diet (Other)
High-carbohydrate low-GI diet
Other
干预措施: Diet (Other)
Low-carbohydrate high-GI diet
Other
干预措施: Diet (Other)
Low-carbohydrate low-GI diet
Other
干预措施: Diet (Other)
结局指标
主要结局
Glucose
时间窗: 22-week period
Lipids
时间窗: 22-week period
次要结局
- Insulin(22-week period)
- LDL and HDL subfractions(22-week period)
- Gut microbiota(22-week period)
- Bile acid(22-week period)
研究者
Huicui Meng
Associate Professor
Sun Yat-sen University
研究点 (1)
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