Oxidative StressXXS SYMPANCT02826083
Study to Evaluate the Effects of XXS on Oxidative Stress in Patients With Mild or Moderate Hyperlipidemia
A study testing XXS and non-XXS in people with Oxidative Stress, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oxidative Stress
- What is being tested?
- XXS and non-XXS
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 182 participants
- Where
- 1 siteFrance
- Study dates
- 17 Nov 2014to 8 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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))
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- XXS, non-XXS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XXSDietary supplement
non-XXSDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| XXS | Experimental | Not described Receives: Dietary Supplement: XXS |
| Placebo | Placebo comparator | Not described Receives: Dietary Supplement: non-XXS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantification of Malondialdehyde (MDA)
Measured: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Quantification of oxidized Low Density Lipoprotein (LDL)
Measured: 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
Measured: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2016 (estimated)
- Study start17 Nov 2014
- Primary completion8 Jan 2018
- Study completion8 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative StressStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 182 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02826083
- Sponsor's protocol ID
- VERGES FUI 2014
- Acronym
- XXS SYMPA
- Status last verified
- Feb 2024
- First submitted
- 30 Jun 2016
- Last updated
- 20 Feb 2024
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02826083
- Acronym / sponsor ID
- XXS SYMPA / VERGES FUI 2014
- Conditions
- Oxidative Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 182 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 17 Nov 2014 (actual)
- Primary completion
- 8 Jan 2018 (actual)
- Study completion
- 8 Jan 2018 (actual)
- First posted
- 7 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| XXS | Experimental | Dietary Supplement: XXS |
| Placebo | Placebo comparator | Dietary Supplement: non-XXS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XXS | Dietary supplement | XXS |
| non-XXS | Dietary supplement | Placebo |
Primary outcome
Quantification of Malondialdehyde (MDA)
Time frame: 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing XXS and non-XXS in people with Oxidative Stress, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantification of Malondialdehyde (MDA) (time frame: Change from baseline at 1 month, 3 months, 6 months after treatment with XXS). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2024.