Tokyo, March 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061032) titled 'Evaluation of changes in serum magnesium concentrations following oral administration of different magnesium salts' on March 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Tsuno Rice Fine Chemicals Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 20
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 Size - 10
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 03 Month 19 Day
Anticipated trial start date - 2026 Year 03 Month 30 Day
Last follow-up date - 2026 Year 04 Month 28 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069702
Disclaimer: Curated by HT Syndication.
