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

This study has been completed.
Sponsor:
Information provided by:
Multimed
ClinicalTrials.gov Identifier:
NCT00742703
First received: August 27, 2008
Last updated: March 6, 2009
Last verified: March 2009
  Purpose

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.


Condition Intervention
Moderated Cholesterolemia
Other: Mineralized water
Other: Low mineralized water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: Study of the Effects of a Mineralized Water Ingestion Upon Lipidic Absorption Mechanisms

Resource links provided by NLM:


Further study details as provided by Multimed:

Primary Outcome Measures:
  • Blood LDL Cholesterol rate. [ Time Frame: Day-1, day-56, day-63, day-119 of study ] [ Designated as safety issue: No ]
  • Post-prandial blood triglycerides rate. [ Time Frame: Day-1, day-56, day-63, day-119 of the study ] [ Designated as safety issue: No ]

Estimated Enrollment: 12
Study Start Date: August 2008
Arms Assigned Interventions
Experimental: 1 Other: Mineralized water
Active Comparator: 2 Other: Low mineralized water

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00742703

Locations
France
Biofortis
Nantes, France, 44200
Sponsors and Collaborators
Multimed
Investigators
Principal Investigator: Zaïr Yassine, MD BioFortis
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00742703     History of Changes
Other Study ID Numbers: 9808, IDRCB: 2008-A00743-52
Study First Received: August 27, 2008
Last Updated: March 6, 2009
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

ClinicalTrials.gov processed this record on April 17, 2014