UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006554 |
|---|---|
| Receipt number | R000007611 |
| Scientific Title | Effects of Cooking Using Multi-ply Cookware on Absorption of Potassium and Vitamins - A Randomized Double-blind Placebo Controlled Study |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2011/10/17 17:49:26 |
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Basic information
Public title
Effects of Cooking Using Multi-ply Cookware on Absorption of Potassium and Vitamins - A Randomized Double-blind Placebo Controlled Study
Acronym
Effects of the Amount and Cooking of Vegetables on Urinary Potassium Excretion and Vitamin Absorption
Scientific Title
Effects of Cooking Using Multi-ply Cookware on Absorption of Potassium and Vitamins - A Randomized Double-blind Placebo Controlled Study
Scientific Title:Acronym
Effects of the Amount and Cooking of Vegetables on Urinary Potassium Excretion and Vitamin Absorption
Region
| Japan |
Condition
Condition
Arteriosclerosis
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Effect of daily 350g vegetables intake for 2 weeks by cooking with multi-ply cookware and ordinary cookware on the absorption and metabolism of nutriments
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Total cholesterol, HDL cholesterol, LDL cholesterol, Oxidized LDL
Key secondary outcomes
24-hour urine sodium/ potassium ratio
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test products: Group A
Daily ingestion of 350 g vegetables cooked without water using multi-ply cookware (double-blind group)
Interventions/Control_2
Placebo products: Group B
Daily ingestion of 350 g vegetables cooked using ordinary cookware
(double-blind group)
Interventions/Control_3
Control Group: Group C
Containing to take meals daily as usual during the intervention
(non-treated control)
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 27 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.University and Graduate School male and female students
2.Those who signed the informed consent for participation in the study
Key exclusion criteria
1. Those who can not take 350g of vegetables supplied by the study
2. Those who failed to take photograph of their vegetable intake
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yukio YAMORI |
Organization
Mukogawa Women's University
Division name
Institute for World Health Development
Zip code
Address
4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN
TEL
+81-798-45-9980
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Mari MORI |
Organization
Mukogawa Women's University
Division name
Institute for World Health Development
Zip code
Address
4-16 Edagawa-cho, Nishinomiya-City, Hyogo 663-8143, JAPAN
TEL
+81-798-45-9980
Homepage URL
project@mukogawa-u.ac.jp
Sponsor or person
Institute
Institute for World Health Development, Mukogawa Women's University
Institute
Department
Personal name
Funding Source
Organization
Vita Craft Japan Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Graduate School of Human and Environmental Studies, Kyoto University. Kinsuke Tsuda laboratory
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
京都大学大学院 人間・環境学研究科（京都府）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
By the intervention, group A and B who took supplied vegetables daily showed significant increase in vitamin C, beta-carotene and folic acid in the blood.
Only in group A oxidized LDL was significantly decreased.
24-hour urine samples indicated the significant improvements of potassium excretion and sodium/potassium ratio.
The 58th Annual Conference of the Japanese Society of Nutrition and Dietetics
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 17 | Day |
Last modified on
| 2011 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007611
