NCT00812617

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

December 19, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 22, 2008

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 6, 2009

Status Verified

October 1, 2009

First QC Date

December 19, 2008

Last Update Submit

October 5, 2009

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Fasting total cholesterol, LDL cholesterol, and triglyceride levels

    Every 4 weeks (Overall 20 weeks)

Secondary Outcomes (4)

  • Fasting serum glucose and HbA1c levels

    Every 4 weeks (Overall 20 weeks)

  • Serum uric acid level

    Every 4 weeks (Overall 20 weeks)

  • Serum adiponectin and leptin levels

    Week 0, Week 12

  • Urinary oxidative stress marker

    Week 0, Week 12

Study Arms (2)

Mineral water 1

EXPERIMENTAL
Dietary Supplement: Mineral water (Hita, Oita, Japan)

Mineral water 2

EXPERIMENTAL
Dietary Supplement: Mineral water (Aso-gun, Kumamoto, Japan)

Interventions

Mineral water (Hita, Oita, Japan)DIETARY_SUPPLEMENT
Mineral water 1
Mineral water (Aso-gun, Kumamoto, Japan)DIETARY_SUPPLEMENT
Mineral water 2

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hiroshima University

Hiroshima, 734-8551, Japan

Location

MeSH Terms

Interventions

Mineral Waters

Intervention Hierarchy (Ancestors)

WaterHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Fumiko Higashikawa, PhD

    Hiroshima University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 19, 2008

First Posted

December 22, 2008

Study Start

December 1, 2008

Study Completion

September 1, 2009

Last Updated

October 6, 2009

Record last verified: 2009-10

Locations

JP(1)