Tokyo, July 23 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062297) titled 'A verification study of the effects of test food consumption on mineral absorption' on July 22.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Daicel Corporation

Condition: Condition - Healthy Japanese Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To verify the effects of test food consumption on mineral absorption. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - 7 days x 2

Test 1: Food containing lactobionic acid Test 2: Food not containing lactobionic acid Prescribed meals: Kikubari Gozen (Nichirei Foods Inc.), Sato no Gohan (SATO FOODS CO., LTD.), Fujisan no Tennen Sui (IRIS FOODS INC.) Mineral load: Multi-mineral supplement (DHC Corporation)

Test 1: Consume 2 tablets per day with water for 7 days, from 6 days before the test to the day of the test. On the day of the test, consume simultaneously with the mineral load. Test 2: Consume 2 tablets per day with water for 7 days, from 6 days before the test to the day of the test. On the day of the test, consume simultaneously with the mineral load. Prescribed meals: Replace a total of 4 meals (dinner on the day before the test, and breakfast, lunch, and dinner on the day of the test) with the prescribed meals. Consume each meal over 15 minutes. Consume dinner on the day before the test by 21:00. Consume breakfast on the day of the test after the completion of the pre-consumption examination. Consume lunch on the day of the test after the completion of the 2-hour post-consumption examination. Consume dinner on the day of the test by 21:00. Mineral load: Consume 3 tablets with water after consuming breakfast on the day of the test. *If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

* Test 1 followed by Test 2. * The washout period is 1 week or more. Interventions/Control_2 - 7 days x 2

Test 1: Food not containing lactobionic acid Test 2: Food containing lactobionic acid Prescribed meals: Kikubari Gozen, Sato no Gohan, Fujisan no Tennen Sui Mineral load: Multi-mineral supplement

Test 1: Consume 2 tablets per day with water for 7 days, from 6 days before the test to the day of the test. On the day of the test, consume simultaneously with the mineral load. Test 2: Consume 2 tablets per day with water for 7 days, from 6 days before the test to the day of the test. On the day of the test, consume simultaneously with the mineral load. Prescribed meals: Replace a total of 4 meals (dinner on the day before the test, and breakfast, lunch, and dinner on the day of the test) with the prescribed meals. Consume each meal over 15 minutes. Consume dinner on the day before the test by 21:00. Consume breakfast on the day of the test after the completion of the pre-consumption examination. Consume lunch on the day of the test after the completion of the 2-hour post-consumption examination. Consume dinner on the day of the test by 21:00. Mineral load: Consume 3 tablets with water after consuming breakfast on the day of the test. *If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day.

* Test 1 followed by Test 2. *The washout period is 1 week or more.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - 1. Japanese

2. Men aged 20-69 years, or women aged <=69 years who have been postmenopausal for at least 1 year

3. Healthy individuals

4. Individuals who have a bowel movement every morning Key exclusion criteria - 1. Individuals who are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. Individuals who have an implanted pacemaker or implantable cardioverter defibrillator

3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases

4. Individuals who consume Foods for Specified Health Uses or Foods with Functional Claims

5. Individuals who have lactose intolerance

6. Individuals who are taking or using medications (including herbal medicines) or supplements

7. Individuals who are allergic to medications or foods related to the test product (particularly, milk ingredients, wheat, sesame, mackerel, soybeans, egg, beef, chicken, pork, apple, and gelatin)

8. Individuals who are pregnant, lactating, or planning pregnancy during this study

9. Individuals who are deemed unsuitable for participation in this study by the principal investigator Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 08 Day Date of IRB - 2026 Year 07 Month 08 Day Anticipated trial start date - 2026 Year 07 Month 22 Day Last follow-up date - 2026 Year 11 Month 20 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071292

Disclaimer: Curated by HT Syndication.