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

Not Applicable

Completed

• Conditions: Oxidative Stress
• Interventions: Dietary Supplement: XXS; Dietary Supplement: non-XXS

• Registration Number: NCT02826083
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11-17
• Study First Submitted: 2016-06-30
• Study First Submitted QC: 2016-07-04
• Study First Posted: 2016-07-07
• Primary Completion: 2018-01-08
• Study Completion: 2018-01-08
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-19
• Last Update Posted: 2024-02-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 182

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))

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
XXS	XXS	-
Placebo	non-XXS	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire; 🇫🇷 Dijon, France