UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044503 |
|---|---|
| Receipt number | R000050842 |
| Scientific Title | Study on the absorption and urinary excretion of minerals by intake of mulberry leaf green juice and baby oligo. |
| Date of disclosure of the study information | 2021/06/26 |
| Last modified on | 2021/10/12 16:39:33 |
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Basic information
Public title
Study on the absorption and urinary excretion of minerals by intake of mulberry leaf green juice and baby oligo.
Acronym
Study on the absorption and urinary excretion of minerals by intake of mulberry leaf green juice and baby oligo.
Scientific Title
Study on the absorption and urinary excretion of minerals by intake of mulberry leaf green juice and baby oligo.
Scientific Title:Acronym
Study on the absorption and urinary excretion of minerals by intake of mulberry leaf green juice and baby oligo.
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the minerals absorption effect when mulberry leaf green juice and baby oligo with minerals are taken by adults aged more than 20 years old and less than 65 years old.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urinary calcium, urinary magnesium, urinary iron and urinary zinc content.
Key secondary outcomes
Urinary calcium/creatinine ratio, Urinary magnesium/creatinine ratio, Urinary iron/creatinine ratio, Urinary zinc/creatinine ratio, Urinary hydroxyproline content.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg and zinc sulphate 44.0 mg.
Washout for 1week or more.
Intake of calcium carbonate 2139.6 mg, magnesium oxide 803.4 mg, sodium ferrous citrate 85.5 mg, zinc sulphate 43.5 mg and mulberry leaf green juice 8.0 g.
Washout for 1week or more.
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg, zinc sulphate 44.0 mg and baby oligo 7.5
*Intake with breakfast.
*Eat prescribed diet for breakfast and lunch.
*Drink distilled water for something to drink.
Interventions/Control_2
Intake of calcium carbonate 2139.6 mg, magnesium oxide 803.4 mg, sodium ferrous citrate 85.5 mg, zinc sulphate 43.5 mg and mulberry leaf green juice 8.0 g.
Washout for 1week or more.
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg, zinc sulphate 44.0 mg and baby oligo 7.5
Washout for 1week or more.
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg and zinc sulphate 44.0 mg.
*Intake with breakfast.
*Eat prescribed diet for breakfast and lunch.
*Drink distilled water for something to drink.
Interventions/Control_3
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg, zinc sulphate 44.0 mg and baby oligo 7.5
Washout for 1week or more.
Intake of calcium carbonate 2497.2 mg, magnesium oxide 829.0 mg, sodium ferrous citrate 94.2 mg and zinc sulphate 44.0 mg.
Washout for 1week or more.
Intake of calcium carbonate 2139.6 mg, magnesium oxide 803.4 mg, sodium ferrous citrate 85.5 mg, zinc sulphate 43.5 mg and mulberry leaf green juice 8.0 g.
*Intake with breakfast.
*Eat prescribed diet for breakfast and lunch.
*Drink distilled water for something to drink.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese who are more than 20 years old and less than 65 years old.
Key exclusion criteria
1.Persons who have chronic illness, receiving medication, have a serious disease history
2.Persons who are allergic to the test food
3.Persons who usually take a large amount of test food
4.Persons who usually take medicine, specified health food, healthy food that may affect mineral absorption.
5.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
6.Persons who were judged as inappropriate for study participants by the principal investigator
7.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nozomi |
| Middle name | |
| Last name | Ando |
Organization
Natural Science Co.,Ltd.
Division name
Research and Development Department
Zip code
136-0073
Address
3-4-27 Kitasuna, Koto-ku, Tokyo 136-0073, JAPAN
TEL
03-5665-2311
ando@natural-s.jp
Public contact
Name of contact person
| 1st name | Kosei |
| Middle name | |
| Last name | Nishikawa |
Organization
Healthcare Systems Co., Ltd.
Division name
Research and Development Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
03-6809-2722
Homepage URL
nishikawa@hc-sys.jp
Sponsor or person
Institute
Healthcare Systems Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Healthcare Systems 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 Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2021 | Year | 06 | Month | 26 | 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
10
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
| 2021 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2021 | Year | 10 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050842
