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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014