Tokyo, Nov. 8 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059691) titled 'Effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese' on Nov. 7.

Study Type: Interventional

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

Primary Sponsor: Institute - Yotsuba Milk Products Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of continuous consumption of the test food on salivary IgA secretion in healthy Japanese. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Chewable tablet containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one tablet once a day with water in the morning (within two hours after waking up).

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: Eight weeks Test product: Chewable tablet not containing Lactococcus cremoris subsp. cremoris YRC3780 powder Administration: Take one tablet once a day with water in the morning (within two hours after waking up).

*If you forget to take the test food, take it as soon as you remember. Daily dose should be taken within the day and not carried over to the next day.

Eligibility: Age-lower limit - 60 years-old = 60 at the time of agreement to participate in this study

3. Men whose body weight is >= 50.1 kg, women whose body weight is >= 37.6 kg

4. Individuals whose BMI is >= 17.6 kg/m2 and =< 29.9 kg/m2

5. Individuals who are able to discontinue the intake of other lactic acid bacteria-related foods and oligosaccharides during this study

6. Healthy individuals Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

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, gastrointestinal disorder, congenital disease, or any other chronic diseases

4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

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

6. Individuals who are allergic to medicines or foods related to the test product

7. Individuals who have diarrhea by consuming yogurt

8. Individuals who have used expectorants or antibiotics that affect IgA, or medicines that affect intestinal function, within one month prior to this study (those who use them during this study will be discontinued from participation)

9. Individuals who are diagnosed with dementia

10. Individuals who have been diagnosed with undernutrition

11. Individuals whose saliva volume is less than 1 mL even after more than 3 minutes of collection, or whose salivary flow rate is less than 100 mg per minute

12. Individuals who are pregnant, lactating, or planning to become pregnant during this study

13. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study

14. Individuals who are judged as ineligible to participate in this study by the physician Target Size - 80

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 10 Month 22 Day Date of IRB - 2025 Year 10 Month 22 Day Anticipated trial start date - 2025 Year 11 Month 07 Day Last follow-up date - 2026 Year 03 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068276

Disclaimer: Curated by HT Syndication.