Oxidative Stress
Conditions
Brief 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.
Interventions
DIETARY_SUPPLEMENTXXS
DIETARY_SUPPLEMENTnon-XXS
Sponsors
Centre Hospitalier Universitaire Dijon
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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))
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quantification of Malondialdehyde (MDA) | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
| Quantification of oxidized Low Density Lipoprotein (LDL) | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
Secondary
| Measure | Time frame |
|---|---|
| Measure of overall free-radical defences in the blood by KRL Kyrial Internationaltest | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
Other
| Measure | Time frame |
|---|---|
| Quantification of LDL | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
| Quantification of High Density Lipoprotein (HDL) | Change from baseline at 1 month, 3 months, 6 months after treatment with XXS |
Countries
France
Outcome results
None listed