Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Glucose-iAUC(0-180min)
研究概览
简要总结
The goal is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal.
详细描述
From a previous pilot study (BTS1130/17) there is first evidence that the native whey product with alpha-glucosidase inhibiting properties (Pep2Dia®) has the potential to modulate postprandial hyperglycaemia in prediabetic subjects.
Thereby, incremental areas under the curve (iAUC) of glucose as the primary outcome were significantly reduced by a single dosage of 1400 mg Pep2Dia® compared to placebo the second study is to investigate the 180 min postprandial response on blood glucose and insulin levels after intake of Pep2Dia® in two different dosages compared to placebo in the context of a meal challenge test, providing 75 g of carbohydrates. Pep2Dia® will be administered 15 min prior to a standardized challenge meal. Furthermore, the 120 min postprandial incretin response in terms of Glucagon-like Peptide-1 (GLP-1) will be determined. Changes in insulin sensitivity will be determined by the Matsuda-index as appropriate outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female subjects (minimum one third of each gender) with prediabetic HbA1c values between 5.7% - 6.4% and/or fasting glucose ≥ 5.6 mmol/L (≥ 100 mg/dL) and < 7.0 mmol/L (< 125 mg/dL) (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%)
- •Body mass index 19-35 kg/m2
- •Non-smoker
- •Caucasian
- •Availability and presence in the study units for approx. 3.5 hours/ week for 3 times.
- •Signed informed consent form
- •No changes in food habits or physical activity 3 months prior to screening and during the study
排除标准
- •Presence of disease or drug(s) influencing digestion and absorption of nutrients or bowel habits
- •Intake of medications known to affect glucose tolerance, e.g., diabetic medication, steroids, protease inhibitors or antipsychotics
- •Diagnosed Typ 2-Diabetics with medical treatment
- •Chronic intake of substances affecting blood coagulation (e.g. acetylic acid (100 mg as standard prophylactic treatment allowed when dose is stable 1 month prior to screening), anticoagulants, diuretics, thiazides (diuretics and thiazides allowed e.g. for hypertension treatment when dose is stable 1 month prior to screening)), which in the Investigator's opinion would impact patient safety
- •Severe liver, renal or cardiac disease
- •Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- •Known inflammatory and malignant gastrointestinal diseases (i.e. colitis ulcerosa, Morbus Crohn, celiac disease, malignant diseases e.g. colon-cancer, rectum cancer, pancreatitis)
- •Clinically relevant findings as established by medical history, physical examination, clinical laboratory and/or vital signs
- •Major medical or surgical event requiring hospitalization within the previous 3 months
- •Intake of antibiotics within 4 weeks before the test days
- •Known alcohol abuse or drug abuse
- •Pregnant or breast feeding women
- •Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- •Known HIV-infection
- •Known acute or chronic hepatitis B and C infection
- •Blood donation within 4 weeks prior to visit 1 or during the study
- •Subject unable to co-operate adequately
结局指标
主要结局
Glucose-iAUC(0-180min)
时间窗: Day 1, Day 15, Day 29
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration (according to ISO 26642:2010(E)
次要结局
- GLP-1-iAUC(0-120min)(Day 1, Day 15, Day 29)
- Cmax(Day 1, Day 15, Day 29)
- Tbaseline(Day 1, Day 15, Day 29)
- Tmax(Day 1, Day 15, Day 29)
- AUC(0-180min)(Day 1, Day 15, Day 29)
- Max_increase(Day 1, Day 15, Day 29)
- Matsuda index(Day 1, Day 15, Day 29)
- Increase of insulin(Day 1, Day 15, Day 29)