Assessment of the Effect of Artificial Sweeteners on Gut Microbiota and Glucose Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
The Objectives of this study is to determine the effect(s) of daily non-caloric artificial sweetener (NAS) consumption (sucralose or aspartame) on the composition of the bacteria and also to determine the changes in glucose metabolism.
详细描述
The trial will be 12 weeks randomized, cross-over and double blinded with 2 treatment intervention ( sucralose and aspartame) , there will be a run in period (4 weeks), then phase 1 treatment period for two weeks followed by four weeks washout period then phase 2 treatment period(2 weeks). Healthy, normglycemic (<5.6 mmol/L) males and females ( 17 total) of age 18-45 y with a body mass index (BMI) 20-25 kg/m2 will be recruited.
Each participants will be given the dose of sweetener aspartame or sucralose during the treatment phase in a double-blind procedure.
the participant will be asked to consume the sweetener in a mixed flavoured beverage during each visit in the treatment phase.
Blood and stool sample collection will take place before after the run-in period, and after the washout period, as well as after each two-week treatment period.
glucose measurement: Capillary blood will be collected during each visit by registered nurse. Blood will be collected at fasting and at 12,30,45,60,90 and 120 minutes after the participants drink a glucose drink (75g glucose) for Oral glucose tolerance test.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 20-25 kg/m2
- •Fasting blood glucose (FBG) < 5.7 mmol/L
- •women with regular menstrual cycle.
排除标准
- •probiotic or antibiotic use within 6 months prior to the start of the study
- •metabolic or gastrointestinal disorders (diabetes mellitus types 1 and 2, inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), celiac disease, phenylketonuria)
- •pregnant or lactating women
研究组 & 干预措施
Sucralose-Aspartame
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
干预措施: Sucralose-Aspartame (Dietary Supplement)
Sucralose-Aspartame
Generic name: sucralose or aspartame, Dosage form: powder, Duration:seven days.
干预措施: Aspartame-Sucralose (Dietary Supplement)
Aspartame-Sucralose
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
干预措施: Sucralose-Aspartame (Dietary Supplement)
Aspartame-Sucralose
Generic name: aspartame or sucralose, Dosage form: powder, Duration:seven days.
干预措施: Aspartame-Sucralose (Dietary Supplement)
结局指标
主要结局
Fasting Blood Glucose
时间窗: 0-200 mins
Fasting blood glucose level and 2-hour oral glucose tolerance test (OGTT).
次要结局
- Insulin, glucagon,GIP & GLP-1(4 times during the 12 weeks period)
- Fecal Microbiome & short chain fatty acids measurements(4 times during the 12 weeks period)