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

March 6, 2009 updated by: Multimed
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Nantes, France, 44200
        • Biofortis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Other: Mineralized water
Active Comparator: 2
Other: Low mineralized water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood LDL Cholesterol rate.
Time Frame: Day-1, day-56, day-63, day-119 of study
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
Day-1, day-56, day-63, day-119 of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Multimed

Investigators

  • Principal Investigator: Zaïr Yassine, MD, Biofortis

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Study Registration Dates

First Submitted

August 27, 2008

First Submitted That Met QC Criteria

August 27, 2008

First Posted (Estimate)

August 28, 2008

Study Record Updates

Last Update Posted (Estimate)

March 9, 2009

Last Update Submitted That Met QC Criteria

March 6, 2009

Last Verified

March 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • 9808
  • IDRCB: 2008-A00743-52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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