UMIN-CTR Clinical Trial

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
Email	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
Email	nishikawa@hc-sys.jp

Sponsor
Institute	Healthcare Systems Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050842