Prospective, Randomized, Single-center, Double-blinded, Placebo-controlled Study on Safety and Tolerability of the Krill Powder Product in Slightly Obese Study Subjects With Moderately Elevated Blood Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Change in Adverse events
研究概览
简要总结
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
As a primary endpoint of the study, the total number of reported adverse events were compared in the study subject groups taking 8 capsules (4 g) krill oil powder or 8 capsules (4 g) of placebo for the 8-week follow-up period.
详细描述
Krill powder is a food supplement rich in active ingredients such as fatty acids, phospholipids, protein and antioxidants like astaxanthin. It is considered to be more effective in lowering triglyceride values than fish oils and it may have positive effect on cholesterol values as well. Krill proteins may have positive effect on blood pressure and astaxanthin has anti-oxidative and anti-inflammatory properties. Thus, krill powder has a lot of potential in improving lipid values and having other positive health effects on cardiovascular system. However, there haven't been many clinical studies done with krill powder and thus systematic data on human safety is limited.
The aim of this study was to systematically collect data on safety and tolerability of krill powder in humans and simultaneously gain efficacy data by measuring the risk factors for cardiovascular disease.
The study was a randomised, double-blinded, placebo-controlled intervention study with slightly obese subjects with mildly or moderately elevated blood pressure. Study was conducted at two study sites in Central (Tampere) and Northern Finland (Oulu). In total 35 subjects were randomised according to randomisation list to two groups (krill powder or placebo) in a balanced manner (1:1), separately for both gender and site. Concealed allocation was used to keep both subjects and staff blinded. The study consisted of a pre-screening, Day -7-(-14) screening visit, Day 0 baseline (Randomization visit) and 8-week safety and tolerance follow-up period with three follow-up visits on Day 14, Day 28 and Day 56.
A total of 6 study visits were included. At pre-screening visit the study subjects were requested to sign pre-screening visit informed consent form. A structured interview on demographics (age, sex, ethnicity), previous and current diseases, current medication, alcohol and tobacco consumption and use of dietary supplements (especially fish oil and other n-3 fatty acid (FA) supplements, plant sterols and cholesterol lowering fiber supplements (guar gum, glucomannan, oat fiber etc.) and use of fish foods was carried out at the screening visit and replicated at the day 56 visit. Study included one test product: krill powder derived from antarctic krill (Euphausia Superba) (Rimfrost Pristine®, Rimfrost AS, PO box 234, 6099 Fosnavaag, Norway) and placebo product and both were given in capsule form, 4 capsules in the morning and 4 in the evening.
Nutritional counselling regarding the consumption of fish, omega-3 and -6 fatty acids, food supplements and investigational product for the duration of the study were given for the study subjects at the screening visit by a study nurse or registered dietitian and compliance was followed throughout the study. The subjects were advised to keep their medication, lifestyle, background diet and body weight constant during the study and deviation were recorded into the diary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Slightly obese female and male subjects (BMI between 25-30 kg/ m2)
- •Mildly or moderately elevated blood pressure (RR systolic 130-159/ diastolic under 99)
- •Signed written informed consent
排除标准
- •Medication potential to affect serum lipids (lipid-lowering drugs)
- •Familial hypercholesterolemia, marked combined hyperlipidemia, condition that would impair fat absorption (e.g. chronic pancreatitis, pancreatic lipase deficiency syndrome)
- •Any untreated medical condition affecting absorption of fat
- •Type 1 and 2 diabetes
- •Cancer or other malignant disease within the past five years
- •Periodical hormone replacement therapy
- •High intake of oily fish (>2 times per week as a principal meal) (i.e. salmon, herring, sardines, mackerel, vendace)
- •Alcohol consumption >15 doses per week
- •Pregnant, lactating or wish to become pregnant
- •Hypersensitivity to fish or any of the components of the test products
- •Regular use (> 3 times per week) of n-3 or other fatty acid supplements, plant sterols or fiber supplements 4 weeks before randomization
- •Lack of suitability for participation in the trial, for any medical reason, as judged by the PI
研究组 & 干预措施
Krill oil
Krill powder capsules, 4 g
干预措施: Nutritional counseling A (Dietary Supplement)
Placebo
Placebo capsules, maize strach, 4 g
干预措施: Nutritional counselling B (Dietary Supplement)
结局指标
主要结局
Change in Adverse events
时间窗: Screening, baseline, day 28, day 56
Total number of reported adverse events
次要结局
- Type of adverse event(Screening, baseline, day 28, day 56)
- Change in Aspartate transaminase (AST)(Screening, baseline, day 28, day 56)
- Change in blood glucose(Screening, baseline, day 28, day 56)
- Change in Systolic blood pressure(Screening, baseline, day 28, day 56)
- Change in Alanine transaminase (ALT)(Screening, baseline, day 28, day 56)
- Change in total cholesterol(Screening, baseline, day 28, day 56)
- Change in Low density lipoproteine (LDL)-cholesterol(Screening, baseline, day 28, day 56)
- Change in Diastolic blood pressure(Screening, baseline, day 28, day 56)
- Change in thyrotropin(Screening, baseline, day 28, day 56)
- Change in creatinine(Screening, baseline, day 28, day 56)
- Change in blood count(Screening, baseline, day 28, day 56)
- Change in Triglycerides(Screening, baseline, day 28, day 56)
- Change in gamma glutamyl transferase(Screening, baseline, day 28, day 56)
- Change in High density lipoproteine (HDL)-cholesterol(Screening, baseline, day 28, day 56)
- Change in Thyroid stimulating hormone (TSH)(Screening, baseline, day 28, day 56)