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

NCT ID: NCT02826083

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

182 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-17

Study Completion Date

2018-01-08

Brief Summary

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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

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Conditions

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Oxidative Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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XXS

Group Type EXPERIMENTAL

XXS

Intervention Type DIETARY_SUPPLEMENT

Placebo

Group Type PLACEBO_COMPARATOR

non-XXS

Intervention Type DIETARY_SUPPLEMENT

Interventions

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XXS

Intervention Type DIETARY_SUPPLEMENT

non-XXS

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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))
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Centre Hospitalier Universitaire

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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VERGES FUI 2014

Identifier Type: -

Identifier Source: org_study_id

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