Can Japanese Traditional Foods Lower Blood Pressure in Healthy Volunteers (Horenso)
| Tracking Information | |
|---|---|
| First Received Date ICMJE | June 25, 2009 |
| Last Updated Date | June 25, 2009 |
| Start Date ICMJE | June 2008 |
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) |
| Current Primary Outcome Measures ICMJE |
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 Outcome Measures ICMJE | Not Provided |
| Original Other Outcome Measures ICMJE | 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 | Not Provided |
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Bio-availability Study Intervention Model: Crossover Assignment Masking: 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 Arm (s) | Not Provided |
| Publications * | Not Provided |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 25 |
| Completion Date | September 2008 |
| Primary Completion Date | September 2008 (final data collection date for primary outcome measure) |
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both |
| Ages | 20 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | Japan |
| Administrative Information | |
| NCT Number ICMJE | NCT00928824 |
| Other Study ID Numbers ICMJE | KyorinU |
| Has Data Monitoring Committee | Yes |
| 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 |
| Information Provided By | Kyorin University |
| Verification Date | June 2009 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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