Moderated CholesterolemiaNCT00742703

Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms

A study testing Mineralized water and Low mineralized water in people with Moderated Cholesterolemia, run by Multimed at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The principal objective of this research is the evaluation of the effect of mineralized water consumption upon evolution of LDL Cholesterol and triglycerides, compared to a low mineralized water consumption. Read more about this study

Who is it for?: Ages 20 to 60 years, men onlyHealthy volunteers can take part
Conditions the study is for: Moderated Cholesterolemia
What is being tested?: Mineralized water and Low mineralized water
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 12 participants
Where: 1 siteFrance
Study dates: Aug 2008to not given
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 20 to 60 years
Men only
Healthy volunteers accepted
Adult

Who may be able to join

BMI included between 18.5 and 25 kg/m²
non smoking
moderated hypercholesterolemia

Who cannot join

food allergy
diabetes
high blood pressure
kidney deficiency
thyroid deficiency
metabolism deficiency

Trial locations and contacts

1 site in 1 country.

France1 site

Biofortis
Nantes, 44200

Other trials in France

About this study

Conditions: Moderated Cholesterolemia
Being tested: Mineralized water, Low mineralized water

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mineralized waterOther
Low mineralized waterOther

Study groups in NCT00742703
Study group	Role	What they receive
1	Experimental	Not described Receives: Other: Mineralized water
2	Active comparator	Not described Receives: Other: Low mineralized water

What is being measured

The primary outcome is the main question the study is designed to answer.

Blood LDL Cholesterol rate.
Measured: Day-1, day-56, day-63, day-119 of study
Post-prandial blood triglycerides rate.
Measured: Day-1, day-56, day-63, day-119 of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2008?

First posted28 Aug 2008 (estimated)
Study startAug 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Moderated CholesterolemiaStudies of the same condition, open and under way.
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
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 12 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00742703
Sponsor's protocol ID: 9808
Other IDs: IDRCB: 2008-A00743-52
Status last verified: Mar 2009
First submitted: 27 Aug 2008
Last updated: 9 Mar 2009
Results posted: No
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 9 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms
ClinicalTrials.gov ID: NCT00742703
Acronym / sponsor ID: 9808
Conditions: Moderated Cholesterolemia
Study type: Interventional
Recruitment status: Completed
Enrolment: 12 participants (estimated)
Lead sponsor: MultimedIndustry (pharma, biotech, devices)
Study start: Aug 2008
First posted: 28 Aug 2008 (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.

Study design

Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Other: Mineralized water
2	Active comparator	Other: Low mineralized water

Who may qualify

Ages: 20 to 60 years
Sex: Male only
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (3 listed)

BMI included between 18.5 and 25 kg/m²
non smoking
moderated hypercholesterolemia

Key exclusion criteria (6 listed)

food allergy
diabetes
high blood pressure
kidney deficiency
thyroid deficiency

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
Mineralized water	Other	1
Low mineralized water	Other	2

Primary outcome

Blood LDL Cholesterol rate.
Time frame: Day-1, day-56, day-63, day-119 of study
Post-prandial blood triglycerides rate.
Time frame: Day-1, day-56, day-63, day-119 of the study

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 9 Mar 2009.

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.

Zaïr Yassine, MD principal investigator

BioFortis

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Mineralized water and Low mineralized water in people with Moderated Cholesterolemia, run by Multimed 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 6 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 9 Mar 2009. 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. 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?

Blood LDL Cholesterol rate. (time frame: Day-1, day-56, day-63, day-119 of study). 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?

On the ClinicalTrials.gov record for NCT00742703.

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 9 Mar 2009.