UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053581 |
|---|---|
| Receipt number | R000061145 |
| Scientific Title | Effects of Vinegar on Absorption of Minerals (Ca, Mg) and Water-Soluble Vitamins |
| Date of disclosure of the study information | 2024/04/01 |
| Last modified on | 2024/02/09 15:38:35 |
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Basic information
Public title
Effects of Vinegar on Absorption of Minerals (Ca, Mg) and Water-Soluble Vitamins
Acronym
Effects of Vinegar on Absorption of Minerals (Ca, Mg) and Water-Soluble Vitamins
Scientific Title
Effects of Vinegar on Absorption of Minerals (Ca, Mg) and Water-Soluble Vitamins
Scientific Title:Acronym
Effects of Vinegar on Absorption of Minerals (Ca, Mg) and Water-Soluble Vitamins
Region
| Japan |
Condition
Condition
Healthy Adult Males
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the absorption effects of minerals (Ca, Mg) and water-soluble vitamins when vinegar is consumed with mineral supplements and rice balls
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary calcium level
Key secondary outcomes
Urinary magnesium level, Urinary vitamin (B1, B2, B6, C, niacin, biotin, pantothenic acid, folic acid) levels
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of vinegar, mineral supplement containing 250 mg of calcium and 125 mg of magnesium,and germinated brown rice ball at breakfast.
Washout for 2 weeks.
Intake of water, mineral supplement containing 250 mg of calcium and 125 mg of magnesium,and germinated brown rice ball at breakfast.
Drinking water and lunch are to be provided.
Interventions/Control_2
Intake of water, mineral supplement containing 250 mg of calcium and 125 mg of magnesium,and germinated brown rice ball at breakfast.
Washout for 2 weeks.
Intake of vinegar, mineral supplement containing 250 mg of calcium and 125 mg of magnesium, and germinated brown rice ball at breakfast.
Drinking water and lunch are to be provided
Interventions/Control_3
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
(1) Healthy male between 20 and 60 years old
(2) Subjects who can agree to participate in this study
(3) Subjects who can come to the designated room on the designated date and time, and can collect urine, eat, and drink
Key exclusion criteria
1) Subjects currently suffer from some chronic disease and are receiving drug treatment
(2) Subjects having possibilities for emerging allergy related to the current study
(3) Subjects taking daily mineral or vitamin medications or supplements
(4) Subjects who drink much alcohol
Target sample size
14
Research contact person
Name of lead principal investigator
| 1st name | Joto |
| Middle name | |
| Last name | Yoshimoto |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6, Nakamura-cho, Handa-shi, Aichi
TEL
0569-24-5139
yoshimoto_jyoutou@mizkan.co.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Ogasawara |
Organization
Mizkan Holdings Co., Ltd.
Division name
Central Research Institute
Zip code
475-8585
Address
2-6, Nakamura-cho, Handa-shi, Aichi
TEL
0569-24-5139
Homepage URL
yogasawara1@mizkan.co.jp
Sponsor or person
Institute
Mizkan Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Mizkan Holdings Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Mizkan group
Address
2-6, Nakamura-cho, Handa-shi, Aichi
Tel
0569-24-5139
yoshihiro_tsuchiya@mizkan.co.jp
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 04 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
15
Results
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
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 25 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 25 | Day |
Date analysis concluded
| 2024 | Year | 01 | Month | 25 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 02 | Month | 09 | Day |
Last modified on
| 2024 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061145
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| Registered date | File name |
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