Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia (XXS SYMPA)

University Hospital Center (CHU) Dijon Bourgogne

Status

Completed

Conditions

Oxidative Stress

Treatments

Dietary Supplement: non-XXS

Dietary Supplement: XXS

Study type

Interventional

Funder types

Other

Identifiers

NCT02826083

VERGES FUI 2014

Details and patient eligibility

About

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.

Enrollment

182 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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))