Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperl… (NCT02826083) | Clinical Trial Compass
CompletedNot Applicable
Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia
France182 participantsStarted 2014-11-17
Plain-language summary
Given preliminary data in animal (proprietary data) have shown that XXS (a mixture of natural polyphenolic extracts of edible plants) has a significant and favourable effect on oxidative stress notably with a decrease in certain markers of oxidative stress and on plasma lipid parameters, the investigator proposes to study the effect of 6 months of treatment with XXS in a controlled study against placebo in a population of persons presenting a lipid profile at the upper limit of normal.
Who can participate
Age range
18 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:
* Persons who have provided written consent
* Persons aged over 18 years
* Presenting LDL levels between 1.30 and 1.90 g/l and/or triglyceride levels between 1.5 and 3 g/l
Exclusion Criteria:
* Persons without national health insurance cover
* Pregnant or breastfeeding women
* Adults under guardianship
* Patients with diabetes (Insulin-Dependent Diabetes (IDD) or Non-Insulin-Dependent Diabetes NIDD)
* Patients with coronary artery disease
* Patients with atherosclerosis
* HDL\>0.80 g/l
* receiving treatment with lipid-lowering agents (statins, fibrates, ezetimibe or Ω3)
* Consuming vitamin supplements (A, C, E…)
* Consuming oligoelements or minerals (Se, Zn, Ca…)
* Renal insufficiency (creatinine clearance \< 30 ml/min calculated according to the Modification of the Diet in Renal Disease (MDRD))
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
Quantification of Malondialdehyde (MDA)
Timeframe: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
2
Quantification of oxidized Low Density Lipoprotein (LDL)
Timeframe: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS