The Effect of Supplementation With a Marine Protein Hydrolysate in Patients With Metabolic Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 2
- 主要终点
- Glucose
研究概览
简要总结
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program is finished. It is of interest to find ways to prevent and alleviate metabolic syndrome (MetS), beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. The aim of this study is to investigate the effect of adding a marine protein hydrolysate (MPH) supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that this will lead to beneficial changes in the components of MetS and to an overall healthier metabolic profile.
详细描述
Overweight and obesity are increasing global health problems and the most important contributors to morbidity and mortality. Obesity (abdominal obesity), together with hyperglycemia, dyslipidemia and hypertension forms a cluster of risk factors that is called the metabolic syndrome (MetS). The first-line therapy for MetS is lifestyle intervention - education on a healthy lifestyle leading to a focus on physical activity and diet, which will improve risk factors closely linked to MetS. The maintenance of long-term weight loss is difficult, and individuals often regain weight after an intervention program stops. It is of interest to find ways to prevent and alleviate MetS, beyond the known effects of lifestyle modification and weight loss. Fish has been proposed as a food that may have favorable effects on metabolic health. Previous intervention studies with fish protein in humans and rodents have shown improved insulin sensitivity and glucose tolerance, reduced cholesterol levels in plasma and reduced blood pressure. Intervention studies investigating the effect of cod have mainly focused on the health effect of consuming the whole fillet. Studies on the remaining part of the fish, the residual material, primarily used for production of animal feed, are scarce. There is evidence that cod, and other marine fish, may contain bioactive peptides that have potentially important health effects in humans. Therefore, it is of interest to investigate the possible effect of a daily supplement of marine protein hydrolysate (MPH), taken over a longer period, in a group of patients with abnormal glucose control. The aim of this study is to investigate the effect of adding a MPH supplement to the diet over an 8-week period in a group of adults with established MetS. The investigators expect that supplementation with MPH will lead to beneficial changes in the components of MetS and an overall healthier metabolic profile.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
The provider of the dietary supplement deliver the supplement prepared and packed in equal bags (active/placebo) that we hand out to the participants in an randomized order.
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 40-70 years
- •BMI 27-35 kg/m2
- •Signed informed consent
- •MetS as defined by the presence of at least 3 of the 5 following criteria*:
- •Elevated waist circumference ≥ 94 cm (M), ≥ 80 cm (F)
- •Elevated triglycerides ≥ 1.7 mmol/L (150 mg/dL)
- •Elevated fasting glucose ≥ 5.5 mmol/L (100 mg/dL)
- •Elevated blood pressure S ≥ 130 and/or D ≥85 mmHg
- •Reduced HDL-cholesterol < 1.0 mmol/L (40 mg/dL) (M) <1.3 mmol/L (50 mg/dL) (F)
- •The International Diabetes Foundations (IDF) cut-off points are used.
排除标准
- •Suspected allergy against fish or shellfish
- •Acute infections (may be reconsidered for inclusion at a later time)
- •Chronic disease or therapies that is likely to interfere with the evaluation study results
- •Pregnancy, lactation or planning pregnancy during study period
- •Substance misuse
- •Inability or unwillingness to comply with the requirements of study procedures
结局指标
主要结局
Glucose
时间窗: At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).
Postprandial glucose (mmol/L) change at baseline and after 8 weeks on intervention.
次要结局
- Glucose_met(At baseline and after 8 weeks.)
- Body composition 1(At baseline and after 8 weeks.)
- Body composition 3(First at baseline and after 8 weeks.)
- Body composition 2(At baseline and after 8 weeks.)
- Hormon hunger 1(At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).)
- Hormon hunger 2(At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples (i.e - 15, 0, 20, 40, 80, 120 minutes after baseline).)
- Insulin(At baseline and after 8 weeks, the first sample fasted, thereafter repeated samples every 20 minutes (i.e. -15, 0, 20, 40, 60, 80, 100,120 minutes after baseline).)