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Can Japanese Traditional Foods Lower Blood Pressure in Healthy Volunteers (Horenso)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00928824
Recruitment Status : Completed
First Posted : June 26, 2009
Last Update Posted : June 26, 2009
Sponsor:
Collaborator:
Japanese Society for the Promotion of Science
Information provided by:
Kyorin University

Tracking Information
First Submitted Date  ICMJE June 25, 2009
First Posted Date  ICMJE June 26, 2009
Last Update Posted Date June 26, 2009
Study Start Date  ICMJE June 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2009)
Blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Can Japanese Traditional Foods Lower Blood Pressure in Healthy Volunteers
Official Title  ICMJE Dietary Nitrate in Japanese Traditional Foods Lowers Diastolic Blood Pressure in Healthy Volunteers.
Brief Summary The purpose of this study is to determine whether traditional japanese diet blood pressure in healthy volunteers.
Detailed 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Blood Pressure
Intervention  ICMJE 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.
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 25, 2009)
25
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2008
Actual Primary Completion Date September 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • healthy volunteers

Exclusion Criteria:

  • high/low blood pressure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00928824
Other Study ID Numbers  ICMJE KyorinU
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prof Kamiya Shigeru, Kyorin Daigaku
Study Sponsor  ICMJE Kyorin University
Collaborators  ICMJE Japanese Society for the Promotion of Science
Investigators  ICMJE Not Provided
PRS Account Kyorin University
Verification Date June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP