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Completed

NCT Number: NCT00812617

Effects of Mineral Water Consumption on Serum Lipid Parameters

The purpose of the study is to determine the effect of a specific mineral water on serum lipid concentrations in healthy subjects.

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Key information

Conditions

Healthy

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hiroshima University

Hiroshima, 734-8551, Japan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy as based on medical history and physical examination
  • Fasting serum LDL cholesterol > 100 and/or fasting serum triglyceride > 100
  • Willing to drink mineral water for 12 weeks
  • Willing not to serve as blood donor during the study
  • Informed consent signed

Exclusion criteria

  • Female subjects who are pregnant or nursing a child
  • Participation in any clinical trial up to 90 days before Day 01 of this study
  • Renal or hepatic dysfunction
  • Heart disease

Treatment and study plan

Mineral water (Hita, Oita, Japan)

Dietary Supplement

Mineral water (Aso-gun, Kumamoto, Japan)

Dietary Supplement

Primary outcomes

  1. Fasting total cholesterol, LDL cholesterol, and triglyceride levels

    Time frame: Every 4 weeks (Overall 20 weeks)

Secondary outcomes

  1. Fasting serum glucose and HbA1c levels

    Time frame: Every 4 weeks (Overall 20 weeks)

  2. Serum uric acid level

    Time frame: Every 4 weeks (Overall 20 weeks)

  3. Serum adiponectin and leptin levels

    Time frame: Week 0, Week 12

  4. Urinary oxidative stress marker

    Time frame: Week 0, Week 12

Sponsors and collaborators

Lead sponsor

Hiroshima University

Other

Collaborators

  • Hita Tenryosui Co., Ltd.

Registry information

Official study title

Effects of Mineral Water Consumption on Serum Lipid Parameters: a Double-Blind, Randomized Controlled Trial

Important dates

Study start
2008
Study completion
2009
First posted
Dec 22, 2008
Registry last updated
Oct 6, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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