A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
The aim of this study is to investigate the potential effect of a marine protein hydrolysate (MPH) supplement before a meal on postprandial glucose tolerance in healthy subjects, to achieve more knowledge on this presumed beneficial, blood glucose lowering effect
详细描述
To further investigate the effects of MPH in a single dose of 20 mg/kg of body weight on postprandial blood glucose, insulin and GLP-1 (as markers of glucose metabolism) in healthy, active middle-aged to elderly subjects - age 40-65 years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent
- •Body mass index (BMI) 20-30
排除标准
- •Suspected allergies against fish or shellfish
- •Low or unstable blood pressure
- •Diabetes mellitus, treated pharmacological
- •Chronic diseases or therapies that is likely to interfere with the evaluation of study results
- •Acute infections (may be reconsidered for inclusion at a later time)
- •Allergic to milk, confirmed diagnose
- •Pregnancy
- •Women who are breast-feeding infants
- •Inability or unwillingness to comply with the requirements of study procedures
结局指标
主要结局
Glucose
时间窗: First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline.
Postprandial glucose (mmol/L) change on each day of intervention
次要结局
- Insulin(First sample fasting baseline, thereafter repeated samples every 20 minutes (i.e.20, 40, 60, 80, 100,120,140 minutes after baseline), last at 200 minutes after baseline)
- Hormon 1(First sample fasting baseline, thereafter repeated samples (i.e.20, 40, 60, 100 minutes after baseline), last at 200 minutes after baseline)
- Visual analogue scale (VAS)(First (baseline) symptomscore (as described above) measured fasting , thereafter repeated symptom score i.e. at 20, 40 minutes after baseline, last symptom score measure at 200 minutes after baseline)
- KANE, symptom score(First (baseline) symptom score (as described above) measured fasting and the next measure at 200 minutes after baseline)
