Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- 2 hour postprandial blood glucose concentration
研究概览
简要总结
Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.
Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.
The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.
We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting plasma glucose ≥ 5.6 mmol/l or
- •Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
- •HbA1c ≥ 5.8 %
- •Exclusion criteria:
- •Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
- •High fish intake (> 450 gram/week) or fish allergy
- •Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
- •Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
- •Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
- •High intake of protein supplements powder
- •Pregnancy
- •Planning pregnancy or changes in body weight
排除标准
- 未提供
结局指标
主要结局
2 hour postprandial blood glucose concentration
时间窗: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks
Fasting blood glucose concentration
时间窗: Change in blood glucose concentration from baseline and after 8 weeks between groups
Measured at baseline and after 8 weeks.
次要结局
- Blood concentration of HbA1c(Changes in blood HbA1c concentration from baseline and after 8 weeks between groups)
- Blood concentration of incretins (i.e. GLP-1)(Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups)
- Blood concentration of insulin(Changes in blood insulin concentration from baseline and after 8 weeks between groups)
- HOMA-IR(Changes in HOMAR-IR from baseline and after 8 weeks between groups)
研究者
Kirsten Holven
Professor
University of Oslo