Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia

Inclusion criteria

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.

Exclusion criteria

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.