NCT02343497已完成不适用
Randomized, Double-blind, Placebo-controlled, Parallel-group Design, Monocentric Study on Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidemia
Ajinomoto Foods Europe SAS2 个研究点 分布在 1 个国家目标入组 68 人开始时间: 2014年8月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- fasting plasma triglycerides
研究概览
简要总结
The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be fulfilled at V0:
- •Male and female volunteers, able to read and write, aged from 18 to 60 years inclusive at time of screening.
- •Smokers and no smokers.
- •Subject with a good physical condition confirmed based on the subject's interview and the clinical exam performed by the investigator.
- •Subject with a Body Mass Index (BMI) ≥ 18,5 and < 35 kg/m².
- •Written informed consent provided prior to screening, after receiving and understanding the subject information.
- •Stable body weight (< 3% variation) within the last 3 months prior to screening.
- •Subject registered with the French Social Security, in agreement with the French law on biomedical experimentation.
- •To be fulfilled before V1, randomization visit:
- •Subject with fasting triglyceride concentration ≥ 1.2 and < 4 g/l.
- •Subject with fasting serum LDL-cholesterol ≤ 2.2 g/l.
排除标准
- •To be fulfilled at V0:
- •Subject taking lipid altering drug therapy within 6 weeks prior to screening. Also excluded are supplements known to have significant lipid altering effects, such as:
- •Phytosterols or phytostanols,
- •Red yeast rice extract (Monascus purpureus),
- •Beta-glucans,
- •Omega-3 fatty acids (alpha-linolenic, docosahexaenoic and eicosapentaenoic),
- •Subject using the following medications: systemic corticosteroids (nasal and inhaled corticosteroids are permitted), orlistat, bile acid resins, prescription omega-3 fatty acids, cyclical or non continuous hormone therapy (estrogen or testosterone) excepted stable oestroprogestative or progestative contraception i.e. started at least three months preceding the screening visit.
- •Intake of oestroprogestative or progestative contraception started within less than three months preceding the screening visit.
- •Subject taking antioxidant agents or vitamins within 6 weeks prior to screening.
- •Subject taking astaxanthin-rich foods (red fish and seafood, mostly) or supplements (including krill).
- •Subject following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
- •Subject with any sensitivity or allergy to any of the products used in this clinical trial.
- •Subject that consume more than three (3) units of alcoholic beverage daily. For the purpose of this study, a unit of alcohol is defined as 400 ml of beer, 200 ml of wine or 50 ml of hard spirits.
- •Subject with known human immunodeficiency virus (HIV) seropositivity.
- •Women who are pregnant or breastfeeding, or planning a pregnancy during the duration of the study.
- •Female subject without efficient contraceptive method: hormonal contraception (including patch, contraceptive ring, etc.), intra-uterine device or other mechanical contraception method (condom or diaphragm) or spermicide for all the duration of the study.
- •Subject treated for type 1 or type 2 diabetes mellitus.
- •Subject with known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by the investigator.
- •Subject with symptomatic hypertension, treated or not.
- •Subject treated by antivitamin K.
- •Subject with history of significant gastrointestinal disease such as severe constipation, diarrhea, malabsorptive disease, inflammatory bowel disease (e.g. Crohn's disease, ulcerative colitis) and all kind of gastrointestinal surgery.
- •Subject with thyroid dysfunction or treatment for this pathology.
- •Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study.
- •Subject with history of cancer within 5 years of screening visit (except for successfully treated basal and squamous cell carcinoma of the skin).
- •Subject with any medical contraindication to blood sampling (anemia, clotting defect).
- •Subject practicing intense physical activity (sport, physical exertion at work).
- •Subject with history of drug abuse.
- •Participation to any other clinical trial simultaneously and/or within 1 month prior to screening.
- •Subject who in the opinion of the investigator have a risk of non-compliance to the study procedures or who are otherwise not appropriate to include in this clinical trial.
- •Subject of legal age unable of giving consent.
- •Subject deprived of liberty by judicial or administrative decision.
- •Subject of legal age under legal protection.
- •Subject having received over 4500 euros for clinical trial participation within the prior year including the indemnity for the present study.
结局指标
主要结局
fasting plasma triglycerides
时间窗: 0, 12 weeks
g/l
次要结局
- fasting resistin(0, 12 weeks)
- phosphatidylcholine hydroperoxides(0, 12 weeks)
- adverse events(during the 12 weeks of intervention)
- fasting LDL-cholesterol(0, 12 weeks)
- apolipoprotein A1(0, 12 weeks)
- fasting HDL-cholesterol(0, 12 weeks)
- apolipoprotein B(0, 12 weeks)
- fasting glucose(0, 12 weeks)
- homeostatic model assessment to quantify insulin resistance (HOMA-IR)(0, 12 weeks)
- resting blood pressure(0, 6, 12 weeks)
- fasting insulin(0, 12 weeks)
- fasting adiponectin(0, 12 weeks)
- plasmatic concentrations in astaxanthin(0, 6, 12 weeks)
- fasting cholesterol(0, 12 weeks)
- resting heart rate(0, 6, 12 weeks)
- fasting ghrelin(0, 12 weeks)
- compliance with study product(0, 6, 12 weeks)
- apolipoprotein balance(0, 12 weeks)
- fasting leptin(0, 12 weeks)
研究者
研究点 (2)
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