NCT03932695已完成不适用
Investigation of Milk Peptides on Postprandial Blood Glucose Profile: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages Followed by an Open-label Single Arm Phase to Estimate Long Term Effects
Ingredia S.A.2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2018年9月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Glucose-iAUC(0-180min)
研究概览
简要总结
Aim of the study is to investigate the effect of two different dosages of milk peptides on postprandial blood glucose profile in prediabetic subjects compared to placebo. This will be investigated in a cross-over double blind randomized placebo controlled study design. Additionally, long term effects on glucose status, insulin sensitivity and postprandial blood glucose profile will be investigated in a follow up 6-week open label phase with the low dose only.
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)
盲法说明
first phase of the study is RCT double blind placebo cross-over. The second phase is open during 6 weeks of supplementation
入排标准
- 年龄范围
- 30 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 with prediabetic HbA1c values between 5.7% - 6.4% and/or Fasting blood glucose ≥ 5.6 mmol/l (≥ 100 mg/dl) und < 7.0 mmol/l (< 125 mg/dl) (in venous plasma)
- •Age: 30-70 years
- •Body mass index 19-35 kg/m2
- •Non-smoker
- •Caucasian
- •Availability and presence in the study unit for approx. 3.5 hours/ week for 3 times in a row with approx. 1 week of washout in between.
- •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
- •Participation in a clinical study with an investigational product within one month before start of study
结局指标
主要结局
Glucose-iAUC(0-180min)
时间窗: day 1, day 8, day 15, day 57
Area under the curve calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration
次要结局
- Tmax insulin(day 1, day 8, day 15, day 57)
- Max-Increase(day 1, day 8, day 15, day 57)
- AUC(0-180min):(day 1, day 8, day 15, day 57)
- Cmax(day 1, day 8, day 15, day 57)
- Quicki Index(Baseline and Day 57)
- Tbaseline(day 1, day 8, day 15, day 57)
- Insulin-iAUC(0-180min)(day 1, day 8, day 15, day 57)
- Fasting glucose, fasting insulin(Baseline and Day 57)
- Matsuda index(Baseline and Day 57)
- Tmax(day 1, day 8, day 15, day 57)
- HbA1c level(Baseline (V5) and Day 57 (after 6 weeks))
- HOMA index(Baseline and Day 57)
- Cmax Baseline Insulin Max_increase Insulin(day 1, day 8, day 15, day 57)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Investigation of Milk Peptides (Pep2Dia®) on Postprandial Blood Glucose Profile in Prediabetic SubjectsPrediabetic StateNCT04375449Ingredia S.A.36
已完成
不适用
Impact of Dairy Products on Postprandial InflammationInflammationNutritional InterventionObesityNCT01885416Agroscope Liebefeld-Posieux Research Station ALP21
已完成
不适用
Dairy Proteins and Postprandial Appetite Regulation and Energy ExpenditureObesityNCT01133964University of Copenhagen22
已完成
不适用
Differential Effects of Milk Proteins on Postprandial Lipemia in Response to a Fat-Rich Meal in Type 2 DiabetesPostprandial LipemiaType 2 DiabetesNCT00819975Aarhus University Hospital12
已完成
不适用
Casinomacropeptide and SatietyLack of SatietyExcess Intake of MacronutrientsAppetite DisordersNCT01587911University of California, Davis20