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临床试验/NCT03669796
NCT03669796已完成不适用

A Study of the Effects of Marine Protein Hydrolysate as Dietary Supplement on the Regulation of Postprandial Blood Glucose Metabolism in Healthy Subjects

Helse Møre og Romsdal HF2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2017年11月27日最近更新:
适应症

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

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)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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