UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061032 |
|---|---|
| Receipt number | R000069702 |
| Scientific Title | Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts |
| Date of disclosure of the study information | 2026/03/30 |
| Last modified on | 2026/03/24 09:39:45 |
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Basic information
Public title
Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts
Acronym
Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts
Scientific Title
Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts
Scientific Title:Acronym
Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to measure plasma magnesium concentrations following ingestion of each magnesium salt-containing capsule and to evaluate their absorption.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Plasma magnesium concentration
Key secondary outcomes
Post-Consumption Health Questionnaire
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Take 2000mg capsule containing magnesium derived from rice bran (containing 300mg of magnesium) one time.
Interventions/Control_2
Take 1746mg capsule containing magnesium phosphate, tribasic (containing 300mg of magnesium) one time.
Interventions/Control_3
Take 3000mg capsule containing magnesium bisglycinate (containing 300mg of magnesium) one time.
Interventions/Control_4
Take 2000mg capsule containing magnesium citrate (containing 300mg of magnesium) one time.
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy individuals in their 20s to 40s.
2. Healthy individuals without chronic physical illnesses, as confirmed through medical interviews.
3. Individuals not consuming any food products with fatigue-recovery effects.
4. Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding the details, and can provide written consent to participate in this trial.
5. Individuals who can attend the designated examination date and undergo the examination.
6. Individuals deemed suitable for participation in this trial by the principal investigator.
Key exclusion criteria
1. Individuals currently suffering from any disease and undergoing drug therapy.
2. Individuals with severe disease symptoms such as motor dysfunction or respiratory disorders.
3. Individuals unable to refrain from taking over-the-counter magnesium supplements during the trial period.
4. Individuals with allergies (to pharmaceuticals or trial-related products).
5. Individuals who are pregnant, breastfeeding, or intend to become pregnant during the trial period.
6. Individuals who currently have, or have had within the past month, a habit of continuously taking or applying medications specifically marketed for magnesium fortification or supplementation.
7. Individuals using potent pharmaceuticals (as determined by the principal investigator).
8. Other individuals deemed unsuitable for this trial by the principal investigator.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Toshio |
| Middle name | |
| Last name | Nakamura |
Organization
Tsuno Rice Fine Chemicals Co., Ltd.
Division name
Planning and Deveropment Dept 3. Research and Development Div.
Zip code
649-7194
Address
2283 CHONOMACHI KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
TEL
0736-26-5032
nakamura.toshio@tsuno.co.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Inoue |
Organization
Tsuno Rice Fine Chemicals Co., Ltd.
Division name
Section II. Planning and Deveropment Dept 3. Research and Development Div.
Zip code
649-7194
Address
2283 CHONOMACHI KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
TEL
0736-26-5032
Homepage URL
inoue.yuki@tsuno.co.jp
Sponsor or person
Institute
Tsuno Rice Fine Chemicals Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Tsuno Rice Fine Chemicals 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
Tsuno Food Industrial Ethics Committee
Address
94 SHINDEN KATSURAGI-CHO ITO-GUN WAKAYAMA 649-7194 JAPAN
Tel
0736-22-0061
rd_3dept@tsuno.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
築野ライスファインケミカルズ株式会社 TIWセンター（和歌山県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 30 | 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
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
Preinitiation
Date of protocol fixation
| 2026 | Year | 03 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2026 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 24 | Day |
Last modified on
| 2026 | Year | 03 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069702
