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 range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in the ratio of fasting blood concentrations oxidized LDL / total LDL cholesterol