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

Centre Hospitalier Universitaire Dijon182 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

182

Conditions

Oxidative Stress

Interventions

XXSDIETARY_SUPPLEMENT

non-XXSDIETARY_SUPPLEMENT

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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))

Locations (1)

Centre Hospitalier Universitaire

Dijon, France

Outcomes

Primary Outcomes

Quantification of Malondialdehyde (MDA)

Time frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Quantification of oxidized Low Density Lipoprotein (LDL)

Time frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Secondary Outcomes

Measure of overall free-radical defences in the blood by KRL Kyrial Internationaltest

Time frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Data from ClinicalTrials.gov

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