NCT05391854已完成不适用
Clinical Study to Assess the Long-term Effect of Pep2Dia® on Glucose Homeostasis in Prediabetic Subjects: a 12-week Randomized, Multicenter, Double-blind, Placebo-controlled, Parallel Study
Ingredia S.A.1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2022年6月21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
- 128
- 试验地点
- 1
- 主要终点
- Glycated haemoglobin (HbA1c)
研究概览
简要总结
The goal is to assess the long-term effect of Pep2Dia® compared to placebo intake on blood glucose homeostasis. Respective improvements will be assessed by changes in glycated haemoglobin (HbA1c) before and after the 12-weeks intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
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% and 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%)
- •Age: 25-70 years
- •Body mass index 19-35 kg/m2
- •Current Non-smoker
- •Availability and presence in the study units for approx. 3.5 hours/ week for 2 times.
- •Signed informed consent form
- •No changes in food habits or physical activity 3 months prior to screening and during the study
- •If applicable, stable intake of chronic medication of at least 4 weeks
排除标准
- •Subjects with diagnosed Type 2-Diabetes with medical treatment
- •Presence of disease or drug(s) influencing digestion and absorption of nutrients
- •Intake of medications known to affect glucose tolerance, e.g., diabetic medication SGLT-2 inhibitors, GLP-1 receptor agonists, steroids, protease inhibitors or antipsychotics
- •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 or renal disease or laboratory evidence of hepatic dysfunction (i.e. alkaline phosphatase, ALT, AST >3 x ULN)
- •Acute gastrointestinal diseases including diarrhea and/or vomiting within the last 2 weeks
- •Known inflammatory or 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 food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids, omega-3 fatty acids
- •Intake of antibiotics within 4 weeks before the test days
- •Known alcohol abuse or drug abuse
- •Pregnant or breast-feeding women
- •Weight loss intervention or recent body weight change >5 kg during last 3 months
- •Known or suspected allergy to any component of the investigational product(s) (e.g. milk protein)
- •Blood donation within 4 weeks prior to Visit 1 or during the study
- •Anticipating any planned changes in lifestyle for the duration of the study
- •Participation in another clinical intervention study within the last 4 weeks and concurrent participation in another intervention clinical study
- •Subject unable to co-operate adequately
结局指标
主要结局
Glycated haemoglobin (HbA1c)
时间窗: Before treatment (baseline = day 0); at the end of the treatment (after 3 months = day 85)
Change from baseline Glycated haemoglobin (HbA1c) at 3 months
次要结局
- Tbaseline(Day 1; Day 85)
- hsCRP(Day 1; Day 85)
- GLP-1(Day 1; Day 85)
- SF-12 (Short-fom 12)(Day 1; Day 85)
- Glucose-iAUC(0-180min)(Day 1; Day 85)
- Cmax(Day 1; Day 85)
- Delta Cmax(Day 1; Day 85)
- Tmax(Day 1; Day 85)
- ISI 0-120min(Day 1; Day 85)
- Body composition measurement(Day 1; Day 85)
研究者
研究点 (1)
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