The Effect of Alpha Linolenic Acid Intake on Patients With Elevated Glycemic Status: a Double-blind Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- changes of fasting blood glucose
研究概览
简要总结
The findings of previous experiments suggested that alpha linolenic acid (ALA) has been linked to anti-hyperglycemic, and reducing the risk of diabetes.This is a randomized double-blind cross-over trial, aims to study the effect of ALA on glycemic status and human metabolism. Firstly, the investigators will investigate the efficacy of ALA on improving the indexes of glucose metabolism. Secondly, next generation sequencing (NGS), ultra-high performance liquid chromatography-tandem mass spectrometric (UPLC-MS/MS) and gas chromatography-mass spectrometry detection will be conducted to explore the role of ALA on gut microbiota as well as metabolites. Thirdly, single nucleotide polymorphism will be genotyped by Time-of-flight mass spectrometry to find the gene-environment interaction effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fasting blood glucose 6.1-8.4mmol /L;
- •HbA1c 5.7-7.0%;
- •Patients with previously diagnosed type 2 diabetes with stable drug hypoglycemic treatment and blood glucose controlled well.
排除标准
- •Under 30 years old or over 75 years old;
- •Suffering from severe metabolic disorders, malignancies, psychiatric conditions;
- •undergoing insulin therapy, or antibiotic/probiotic use for more than three consecutive days in the last month.
- •Daily cooking oil is flaxseed oil, rapeseed oil or other α -linolenic acid rich vegetable oil;
- •Intake more than 20g walnuts per day or more than 100g fatty fish per week in the last month;
- •Take nutritional supplements, such as fish oil capsules, perilla seed oil and flaxseed oil capsules, for nearly one month;
- •Allergic to the content of intervention;
- •Failure to eat the tested sample as prescribed and affect the efficacy or safety judgment.
结局指标
主要结局
changes of fasting blood glucose
时间窗: 0 week, 12th week, 24th week and 36th week in the intervention period
fasting blood glucose
changes of glycated hemoglobin (HbA1c)
时间窗: 0 week, 12th week, 24th week and 36th week in the intervention period
glycated hemoglobin (HbA1c)
次要结局
- changes of circulating fatty acids(0 week, 12th week, 24th week and 36th week in the intervention period)
- nutrient-gene interaction on circulating n-3 PUFAs(0 week, 12th week, 24th week and 36th week in the intervention period)
- nutrient-gene interaction on fasting blood glucose(0 week, 12th week, 24th week and 36th week in the intervention period)
- changes in the relative abundance of gut microbiota(0 week, 12th week, 24th week and 36th week in the intervention period)
- nutrient-gene interaction on HbA1c(0 week, 12th week, 24th week and 36th week in the intervention period)
- changes of fecal short-chain fatty acid(0 week, 12th week, 24th week and 36th week in the intervention period)
研究者
Liegang Liu
Professor
Huazhong University of Science and Technology