NCT07479251尚未招募不适用
Glycaemic Index Measurement of an Oral Nutritional Supplement With Biomarker Assessment and Lifestyle Monitoring in Healthy Participants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Glycaemic Index (GI) of ONS
研究概览
简要总结
This clinical trial evaluates the postprandial glycaemic response to an Oral Nutritional Supplement (ONS), a Food for Special Medical Purposes (FSMP), in healthy adults. The study uses a crossover design comparing the ONS to the reference product glucose.
Each participant will consume both test and reference products on three separate occasions each, overall on six test days.
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
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged ≥18 and ≤60 years, adult healthy Caucasian or Chinese participants
- •Stable body weight within the Body Mass Index between 18.5 kg/m2 and 27.9 kg/m2 (inclusive)
- •Glycated hemoglobin < 6%/< 42 mmol/mol
排除标准
- •Pregnant or lactating,
- •Body fat percentage exceeding 30%,
- •Known history of metabolic diseases or diabetes mellitus,
- •Major medical or surgical event requiring hospitalization within the preceding 3 months
- •Medical condition(s) or medication(s) or herbal effects known to affect glucose regulation, tolerance or appetite and/or which influence digestion and absorption of nutrients (excluding oral contraceptives),
- •Use of steroids, protease inhibitors, amphetamines or antipsychotics
结局指标
主要结局
Glycaemic Index (GI) of ONS
时间窗: Blood samples will be obtained at -5, 0, 15, 30, 45, 60, 90, and 120 minutes.
Three GIs for each repeated test of the ONS (based on capillary blood glucose) and their average GI (mean value) will be calculated as per ISO 26642.
次要结局
未报告次要终点
研究者
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