NCT06789263已完成不适用
Clinical Study to Evaluate the Effect of a Collagen Hydrolysate on Postprandial Blood Glucose Profile, Gastric Emptying and GLP-1 Release in Normoglycemic and Prediabetic Subjects: Randomized, Double-blind, Placebo-controlled, Cross-over Design
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
- 30
- 试验地点
- 1
- 主要终点
- Glucose iAUC
研究概览
简要总结
Aim of the study is to investigate the postprandial response on blood glucose, insulin, C-peptide, incretin response and gastric emptying after intake of collagen hydrolysate compared to placebo in normoglycemic and in prediabetic participants. This will be investigated in a cross-over randomized double-blind placebo controlled study design.
In an exploratory part II, timing of intake of collagen hydrolysate in relation to the mixed meal will be investigated in a subgroup of 50% of the participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 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
- •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 normoglycemic 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)
- •Subjects who use an implanted or portable electro-mechanical medical device such as a cardiac pacemaker or infusion pump.
- •Planned MRI during or 4 weeks after the study.
- •Subjects overweighed with abdominal diameter >140 cm
- •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
- •Drug-, alcohol- and medication abuses
- •Pregnant or breast-feeding women
- •Weight loss intervention or recent body weight change >5 kg during the last 3 months
- •Blood donation within 4 weeks prior to Screeningor plan to donate blood 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
- •Subjects considered inappropriate for the study by investigators, including subjects who are unable or unwilling to show compliance with the protocol
研究组 & 干预措施
Placebo
Placebo Comparator
Flavoured water
干预措施: Placebo (Other)
Collagen hydrolysate
Active Comparator
30 min prior to the mixed meal test
干预措施: Collagen hydrolyzed peptides (Dietary Supplement)
Collagen hydrolysate II
Other
together with the mixed meal test
干预措施: Collagen hydrolyzed peptides (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
- Delta Cmax(0-180 minutes postprandially)
- Tmax(0-180 minutes postprandially)
- Fasting glucose(-30 minutes and 0 minutes prior mixed meal)
- GLP-1 iAUC(0-120 minutes postprandially)
- Fasting GLP-1(-30 minutes and 0 minutes prior mixed meal)
- Matsuda-Index(0-120 minutes postprandially)
- Gastric emptying(0-6 hours postprandially)
- Satiety assessment(0-240 minutes postprandially)
- Glucose Cmax(0-180 minutes postprandially)
- Glucose(120 minutes)
- Fasting insulin(-30 minutes and 0 minutes prior to mixed meal)
- Insulin iAUC(0-180 minutes postprandially)
- Fasting C-peptide(-30 minutes and 0 minutes prior mixed meal)
- C-peptide iAUC(0-180 minutes postprandially)
研究者
研究点 (1)
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