NCT05887791已完成不适用
Clinical Study to Assess the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile in Prediabetic and Healthy Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Study With Different Dosages
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Glucose iAUC
研究概览
简要总结
To investigate the effect of two different dosages collagen hydrolysate (CH) on postprandial blood glucose and insulin profile in prediabetic and normo-glycaemic subjects.This will be investigated in a cross-over randomized double-blind placebo controlled study design.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Main Inclusion Criteria:
- •Prediabetic subjects: Male and female subjects with prediabetic HbA1c values between 5.7% and 6.4% and/or fasting glucose ≥ 100 mg/dL and ≤ 125 mg/dL (in venous plasma) (twice confirmed at two independent days if HbA1c is < 5.7%) or Healthy normo-glycaemic subjects: fasting glucose <100 mg/dL and HbA1c is < 5.7%
- •Age: 18-70 years
- •Body mass index 19-35 kg/m2
- •Current Non-smoker
- •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 mellitus with medical treatment
- •Presence of disease or drug(s) influencing digestion (incl. recent intake of antibiotics) 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)
- •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
- •Intake of food supplements known to affect glucose tolerance, e.g., cinnamon capsules, conjugated linoleic acids
- •Drug-, alcohol- and medication abuses
- •Pregnant or breast-feeding women
研究组 & 干预措施
Placebo
Placebo Comparator
Flavoured water
干预措施: Placebo (Other)
Collagen hydrolysate dose 1
Experimental
Source: porcine; standardized to 10 g provided as single dose. Orally applied in flavoured water.
干预措施: Collagen hydrolysate (Dietary Supplement)
Collagen hydrolysate dose 2
Experimental
Source: porcine; standardized to 5 g provided as single dose. Orally applied in flavoured water.
干预措施: Collagen hydrolysate (Dietary Supplement)
结局指标
主要结局
Glucose iAUC
时间窗: 0-180 minutes postprandially
Area under the curve (AUC) calculated as the incremental area under the blood glucose response curve, ignoring the area beneath the fasting concentration: Glucose-iAUC(0-180minutes)
次要结局
- Satiety assessment(0-240 minutes postprandially)
- Glucose Cmax(0-180 minutes postprandially)
- Tmax(0-180 minutes postprandially)
- Delta Cmax(0-180 minutes postprandially)
- T baseline(0-240 minutes postprandially)
- Insulin iAUC(up to 0-240 minutes postprandially)
- GLP-1(0-120 minutes postprandially)
- Glucose iAUC(0-240 minutes postprandially)
- Matsuda-Index(0-120 minutes postprandially)
- Glucose dip(0-240 minutes postprandially)
研究者
研究点 (2)
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