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

NCT02826083 | Completed

• 1 other identifier: VERGES FUI 2014
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

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.

Conditions

Oxidative Stress

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• 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

Other Outcomes (2)

• Quantification of LDL

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

• Quantification of High Density Lipoprotein (HDL)

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

Study Arms (2)

XXS

EXPERIMENTAL

Dietary Supplement: XXS

Placebo

PLACEBO COMPARATOR

Dietary Supplement: non-XXS

Interventions

XXS DIETARY_SUPPLEMENT

XXS

non-XXS DIETARY_SUPPLEMENT

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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))

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

Centre Hospitalier Universitaire

Dijon, 21079, France

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 30, 2016
• First Posted: July 7, 2016
• Study Start: November 17, 2014
• Primary Completion: January 8, 2018
• Study Completion: January 8, 2018
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

FR (1)