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

Oxidative Stress Clinical Trial

— XXS SYMPA  

Official title:

Randomized, Double-blind Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia and on Lipoprotein Kinetics

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02826083
• Other study ID #: VERGES FUI 2014
• Status: Completed
• Phase: N/A
• Start date: November 17, 2014
• Est. completion date: January 8, 2018

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire Dijon
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 182
• Est. completion date: January 8, 2018
• Est. primary completion date: January 8, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 O3)

• 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))

Related Conditions & MeSH terms

• Hyperlipidemias
• Hyperlipoproteinemias
• Oxidative Stress

Intervention

Dietary Supplement:
• XXS

• non-XXS

Locations

Country	Name	City	State
France	Centre Hospitalier Universitaire	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quantification of LDL		Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Other	Quantification of High Density Lipoprotein (HDL)		Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Primary	Quantification of Malondialdehyde (MDA)		Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Primary	Quantification of oxidized Low Density Lipoprotein (LDL)		Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Secondary	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