Continuous Glucose Monitoring During Diets That Differ in Glycemic Load
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Post prandial glucose concentration
研究概览
简要总结
This study test whether a Continuous Glucose Monitor can pickup differences in glucose (in the interstitial fluid) during a dietary intervention using meals with either a high with a low glycemic load.
详细描述
The aim of this study is to determine the suitability of a continuous glucose monitor to detect the impact of a dietary intervention on postprandial blood glucose levels in normal, healthy, free living subjects. We will compare a dietary intervention of meals with a high glycemic load (high post-meal blood glucose) versus meals with a low glycemic load (low post-meal blood glucose) in a cross-over study. In addition, the glucose profiles obtained both via venous blood sampling and via continuous glucose monitor following a standard carbohydrate load will be compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Apparently healthy males and post-menopausal females
- •Age at start of the study ≥ 50 and ≤ 70 years
- •Body mass index (BMI) ≥ 25.0 and ≤ 35.0 kg/m2
- •Fasting blood glucose value of subjects is ≥ 3.4 and < 6.1 mmol/L at screening
- •Being used to eat three meals a day
- •Having a general practitioner
- •Agreeing to be informed about medically relevant personal test-results by a physician
- •Accessible veins on arms as determined by examination at screening.
排除标准
- •Having a medical conditions which might affect the study measurements (including but not limited to: diabetes type 1 and type 2, gastrointestinal disorders, gastrointestinal surgery and inflammatory diseases, as judged by the study physician
- •Reported use of over-the-counter or prescribed medication or food supplements, which may interfere with study measurements as judged by the principal investigator
- •Use of oral antibiotics in 40 days or less prior to the start of the study
- •Reported participation in another nutritional or biomedical study 3 months before the screening or during the study
- •Reported participation in night shift work 2 weeks prior to screening or during the study. Night work is defined as working between mid-night and 6.00 am
- •Reported intense sporting activities > 2h/w. Intense sporting activities are defined as those activities that cause a lack of breath which limits the ability to have a normal conversation
- •Reported alcohol consumption > 10 units/week (female) or > 14 units/week (male)
- •Reported use of any nicotine containing products in the 6 months preceding the study and willing to abstain from use of nicotine containing products during the study itself
- •Reported dietary habits: medically prescribed diet, slimming diet, vegetarian
- •Reported weight loss/gain (> 3 kg) in the last 2 months before the study
- •Being an employee of Unilever or research departments in NUTRIM or the Maastricht University Medical Centre (MUMC+) collaborating in this study
- •Known allergy or intolerance to food products.
- •Blood donation in the past 3 months
研究组 & 干预措施
Low glycemic load
Low glycemic load
干预措施: Low glycemic load (Dietary Supplement)
High glycemic load
High glycemic load
干预措施: High glycemic load (Dietary Supplement)
结局指标
主要结局
Post prandial glucose concentration
时间窗: 0 - 120 minutes after the start of each of the 3 main meals (breakfast, lunch dinner)
Difference in glucose concentrations between the low glycemic load and the high glycemic load diet. Incremental area under the curve after the three main meals (breakfast, lunch, dinner) during both dietary interventions will be calculated. The nine post prandial periods for both low and high glycemic load diet per subject will be combined in the mixed model.
次要结局
- Three-day glucose concentration(From start of dietary intervention until the end 3 days later)
- Day time glucose concentration(Between 07:00-22:00 h)
- Glucose variability(From start of dietary intervention until the end 3 days later)
- Comparison of continuous interstitial glucose with venous blood glucose(-30, -15, 15, 30, 45, 60, 90 and 120 minutes after consumption of a standard meal)
- Night time glucose concentration(Between 22:01-26:59 h)