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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00928824
Other study ID # KyorinU
Secondary ID
Status Completed
Phase N/A
First received June 25, 2009
Last updated June 25, 2009
Start date June 2008
Est. completion date September 2008

Study information

Verified date June 2009
Source Kyorin University
Contact n/a
Is FDA regulated No
Health authority Japan: Ministry of Education, Culture, Sports, Science and Technology
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine whether traditional japanese diet blood pressure in healthy volunteers.


Description:

Japanese traditional diet contains considerably more nitrate/nitrite than the European foods. 80% of dietary nitrate originates from vegetables. Green leafy vegetables, especially spinach, salad and seaweed are rich in nitrates. Other vegetables contain nitrate at lower concentrations, but because they are consumed in greater quantity, they may contribute more nitrate and thus nitrite from the diet. Nitrate/nitrite is attributed multiple health benefits. Japanese people have an exceptional longevity and the lowest rate of heart diseases. On the other hand, gastric cancer rate is high too. Nitrate/nitrite is strongly correlated with these phenomena. Is this high nitrate consumption protective or damaging? Understanding dietary nitrite and nitrate consumption and its metabolism therefore becomes very important.

Aim: To compare conversion of nitrate to nitrite in Japanese people, measured in blood and in saliva during consumption of traditional Japanese foods vs European diet.


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 20 Years and older
Eligibility Inclusion Criteria:

- healthy volunteers

Exclusion Criteria:

- high/low blood pressure

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
traditional Japanese diet
10 days of nitrate rich diet (Japanese traditional). After that switch to nitrate low diet for 10 days (European foods). Study nitrate/nitrite in blood, saliva and blood pressure 3 times in each person (10 min each time). A list of Nitrate rich foods are provided.

Locations

Country Name City State
Japan Kyorin Univessity School of Medicine Tokyo Mitaka shi

Sponsors (2)

Lead Sponsor Collaborator
Kyorin University Japanese Society for the Promotion of Science

Country where clinical trial is conducted

Japan, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure
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