Lipid-lowering Effects of an Astaxanthin Supplement in Volunteers With Mild Dyslipidaemia
- Conditions
- Dyslipidemias
- Interventions
- Dietary Supplement: AstaxanthinDietary Supplement: Placebo
- Registration Number
- NCT02343497
- Lead Sponsor
- Ajinomoto Foods Europe SAS
- Brief Summary
The purpose of this study is to investigate whether astaxanthin supplementation can impact triglyceride plasmatic concentrations in volunteers presenting mild dyslipidemia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 68
To be fulfilled at V0:
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Male and female volunteers, able to read and write, aged from 18 to 60 years inclusive at time of screening.
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Smokers and no smokers.
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Subject with a good physical condition confirmed based on the subject's interview and the clinical exam performed by the investigator.
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Subject with a Body Mass Index (BMI) ≥ 18,5 and < 35 kg/m².
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Written informed consent provided prior to screening, after receiving and understanding the subject information.
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Stable body weight (< 3% variation) within the last 3 months prior to screening.
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Subject registered with the French Social Security, in agreement with the French law on biomedical experimentation.
To be fulfilled before V1, randomization visit:
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Subject with fasting triglyceride concentration ≥ 1.2 and < 4 g/l.
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Subject with fasting serum LDL-cholesterol ≤ 2.2 g/l.
To be fulfilled at V0:
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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),
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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.
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Intake of oestroprogestative or progestative contraception started within less than three months preceding the screening visit.
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Subject taking antioxidant agents or vitamins within 6 weeks prior to screening.
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Subject taking astaxanthin-rich foods (red fish and seafood, mostly) or supplements (including krill).
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Subject following any special diet including, but not limited to liquid, high or low protein, raw food, vegetarian or vegan, etc.
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Subject with any sensitivity or allergy to any of the products used in this clinical trial.
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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.
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Subject with known human immunodeficiency virus (HIV) seropositivity.
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Women who are pregnant or breastfeeding, or planning a pregnancy during the duration of the study.
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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.
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Subject treated for type 1 or type 2 diabetes mellitus.
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Subject with known cardiovascular disease or stroke, except for conditions that are deemed clinically insignificant by the investigator.
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Subject with symptomatic hypertension, treated or not.
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Subject treated by antivitamin K.
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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.
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Subject with thyroid dysfunction or treatment for this pathology.
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Subject with history of severe psychiatric illness which in the opinion of the investigator would interfere with the optimal participation in the study.
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Subject with history of cancer within 5 years of screening visit (except for successfully treated basal and squamous cell carcinoma of the skin).
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Subject with any medical contraindication to blood sampling (anemia, clotting defect).
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Subject practicing intense physical activity (sport, physical exertion at work).
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Subject with history of drug abuse.
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Participation to any other clinical trial simultaneously and/or within 1 month prior to screening.
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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.
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Subject of legal age unable of giving consent.
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Subject deprived of liberty by judicial or administrative decision.
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Subject of legal age under legal protection.
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Subject having received over 4500 euros for clinical trial participation within the prior year including the indemnity for the present study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Astaxanthin Astaxanthin Astaxanthin supplement from Phaffia rhodozyma, 6mg in lipid capsules, 2 caps per day, duration 12 weeks Placebo Placebo filling agent, in lipid capsules, 2 caps per day, duration 12 weeks
- Primary Outcome Measures
Name Time Method fasting plasma triglycerides 0, 12 weeks g/l
- Secondary Outcome Measures
Name Time Method fasting resistin 0, 12 weeks flow cytometry
phosphatidylcholine hydroperoxides 0, 12 weeks HPLC/MS
adverse events during the 12 weeks of intervention number of subjects with adverse events
fasting LDL-cholesterol 0, 12 weeks g/l
apolipoprotein A1 0, 12 weeks g/l
fasting HDL-cholesterol 0, 12 weeks g/l
apolipoprotein B 0, 12 weeks g/l
fasting glucose 0, 12 weeks g/l
homeostatic model assessment to quantify insulin resistance (HOMA-IR) 0, 12 weeks glucose (mg/dl) \* insulin(U/l) / 405
resting blood pressure 0, 6, 12 weeks triplicate measure
fasting insulin 0, 12 weeks mU/l
fasting adiponectin 0, 12 weeks flow cytometry
plasmatic concentrations in astaxanthin 0, 6, 12 weeks HPLC/MS
fasting cholesterol 0, 12 weeks total cholesterol (g/l)
resting heart rate 0, 6, 12 weeks fasting ghrelin 0, 12 weeks flow cytometry
compliance with study product 0, 6, 12 weeks accountability of returned used/unused caps
apolipoprotein balance 0, 12 weeks Apolipoprotein B over Apolipoprotein A1 ratio
fasting leptin 0, 12 weeks flow cytometry
Trial Locations
- Locations (1)
Centre Nutrition Clinique Naturalpha
🇫🇷Lille, France