Evaluate Efficacy of Milk Product Supplemented With Bioactives in Lowering Post Meal Glucose Response: an Acute Study in Chinese Population
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- 3h-iAUC of PPGR
研究概览
简要总结
This is a monocentric, randomized controlled, open-label, 2x2 cross-over study. The main objective of the study is to Evaluate the efficacy of Nestle YIYANG TangLv milk powder in lowering the Post Prandial Glucose Response (PPGR) of a high carbohydrate meal when consumed with the meal.
详细描述
This is an acute, monocentric, open label, randomized, 2-arm, cross-over, clinical trial in 30 subjects of Chinese Han ethnicity. Subjects will receive the two different interventions in a randomized order. This study will assess the efficacy of the investigational product after a single consumption. Day before (V1 and V3) the intervention visits (V2 and V4) the subjects will be admitted at the investigational site for an overnight stay where they will consume a standardized dinner. V2 and V3 will be followed by a wash-out period of 3 days. The two arms are:
Arm 1: skimmed milk (control) Arm 2: Nestle YIYANG TangLv milk powder
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
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Willing and able to sign written informed consent prior to trial entry
- •Deemed able to comply with study protocol for 2-3 weeks
- •Male or female aged 45-75 years (inclusive 45 and 75)
- •HbA1c test results < 6.5% at Visit 1 (Admission 1)
- •Waist circumference ≤90 cm in males and ≤ 85 cm in females
- •Chinese Han ethnic group
- •BMI >18.5 and <28 kg/m2
排除标准
- •Pre-existing chronic medical or psychiatric conditions, as diagnosed by the treating physician (psychiatric illness, asthma or chronic lung disease requiring long term medications or oxygen, diabetes mellitus, chronic infective disease, including tuberculosis, hepatitis B and C, and HIV)
- •Significant medical or surgical event in the past 3 months potentially interfering with study procedures and assessments
- •Known food allergy in particular cow's milk protein allergy (CMPA), lactose and /or soy intolerance or known hypersensitivity/intolerance to any other ingredients in the study product
- •Known substance abuse or alcohol user exceeds following intake, alcohol intake > 2 servings per day. A serving is 0.4 dl of strong alcohols, 1 dl of red or white wine, or 3 dl of beer
- •Consumption of tobacco products, smoking or chewing tobacco
- •History of significant organ dysfunction or disease
- •Subjects with refractory hypertension, and patients with hypertension who are taking antihypertensive drugs (beta-blockers, thiazide diuretics, etc.) that may affect blood glucose metabolism
- •Females currently on hormonal therapy including post-menopausal hormone replacement therapy (PRT) or have been on PRT treatment in the past two months before study participation
- •Known autoimmune and/or genetic disease
- •Known chronic diarrhea or gastrointestinal discomfort
- •Known endocrine and metabolic diseases under drug treatment (e.g., pituitary tumors, thyrotoxicosis due to various causes, Cushing's syndrome etc.)
- •Subjects on systemic corticosteroids, glucocorticoids, or cyclosporine A
- •Recent blood donation (<8 weeks)
- •Pregnant or lactating women
研究组 & 干预措施
YIYANG TangLv milk powder
30g of milk powder (Nestle YIYANG TangLv milk powder) containing 789 mg Reducose® extract, standardized to contain 1% 1-deoxynojirimycin (1-DNJ), 10% of an oil mix and 8% of soluble fiber reconstituted with 180 ml of warm water.
干预措施: Blood collection (Biological)
skimmed milk
25g of commercially available skimmed milk powder reconstituted with 180 ml of warm water.
干预措施: Blood collection (Biological)
结局指标
主要结局
3h-iAUC of PPGR
时间窗: 3 hours
Incremental area under the curve (3h-iAUC0-3h) of the post-prandial plasma glucose concentration (PPGR)
次要结局
- Cmax of PPGR(3 hours)
- iAUC of PPIR(1 hour, 2 hours)
- iCmax of PPIR(3 hours)
- iAUC of PPGR(1hour, 2 hours)
- Tmax of PPGR(3 hours)
- Tmax of PPIR(3 hours)
- iCmax of PPGR(3 hours)
- Cmax of PPIR(3 hours)