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

February 19, 2024 updated by: Centre Hospitalier Universitaire Dijon

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

182

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Dijon, France, 21079
        • Centre Hospitalier Universitaire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: non-XXS
Experimental: XXS
Dietary supplement: XXS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quantification of Malondialdehyde (MDA)
Time Frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
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
Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Other Outcome Measures

Outcome Measure
Time Frame
Quantification of LDL
Time Frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Quantification of High Density Lipoprotein (HDL)
Time Frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Change from baseline at 1 month, 3 months, 6 months after treatment with XXS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 17, 2014

Primary Completion (Actual)

January 8, 2018

Study Completion (Actual)

January 8, 2018

Study Registration Dates

First Submitted

June 30, 2016

First Submitted That Met QC Criteria

July 4, 2016

First Posted (Estimated)

July 7, 2016

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 19, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VERGES FUI 2014

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oxidative Stress

Clinical Trials on XXS

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe