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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006554
Receipt No. 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

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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
Email

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
Email project@mukogawa-u.ac.jp

Sponsor
Institute Institute for World Health Development, Mukogawa Women's University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007611

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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