Study to Assess Antioxidant Efficacy of Spirulina on oxLDL and Lipids Metabolism on Subjects With… (NCT02817620) | Clinical Trial Compass
CompletedNot Applicable
Study to Assess Antioxidant Efficacy of Spirulina on oxLDL and Lipids Metabolism on Subjects With Metabolic Syndrome
France40 participantsStarted 2016-08-24
Plain-language summary
The purpose of this pilot study is to assess the beneficial effect of a spirulina water extract (product named Spirulysat®) compared to a placebo in the blood level ratio of oxidized LDL / total LDL cholesterol in subjects with metabolic syndrome after 12 weeks of consumption
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion Criteria:
To be eligible to the study, male and female volunteers will have to fulfil the following criteria (assessment based on the medical examination performed at V0 with a checking at V1):
* Age between 18 and 65 years (limits included),
* BMI between 25 and 35 kg/m² (limits included),
* With metabolic syndrome defined as central obesity : waist circumference \> 94 cm for man and \> 80 cm for woman associated to at least 2 observed criteria among : Fasting blood triglycerides \> 1.5 g/L and/or Fasting blood HDL cholesterol \< 0.4 g/L for man and \< 0.5 g/L for woman and/or Fasting blood glucose level \> 1 g/L and/or Arterial pressure \> 130/85 mmHg or under antihypertensive treatment,
* For women : non menopausal with the same reliable contraception since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study (condom with spermicide gel accepted) or menopausal without or with hormone replacement therapy started at stable dose since at least 3 months before the beginning of the study and agreeing to keep it during the entire duration of the study,
* Weight stable with +/- 5 % in the last 3 months ,
* Non smoking or with tobacco consumption \< 10 cigarettes / day,
* Good general and mental health with in the opinion of the investigator : no clinically significant and relevant abnormalities of medical history or physical examination,
* Able and willing to participate to the study by complying with the …
What they're measuring
1
Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol