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Completed

NCT Number: NCT02826083

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

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.

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Key information

Conditions

Oxidative Stress

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Universitaire

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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))

Treatment and study plan

XXS

Dietary Supplement

non-XXS

Dietary Supplement

Primary outcomes

  1. Quantification of Malondialdehyde (MDA)

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

  2. 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

  1. 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

Other outcomes

  1. Quantification of LDL

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

  2. Quantification of High Density Lipoprotein (HDL)

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

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study 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

Acronym: XXS SYMPA

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Jul 7, 2016
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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