Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063124) titled 'Exploratory study on the effects of consuming lactic acid bacteria on mental health' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Meiji Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To explore the effects of 4-week consumption of foods containing live or killed lactic acid bacteria on mental health, compared with a placebo food
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral intake of 1 g of powder containing live lactic acid bacteria once daily for 4 weeks
Interventions/Control_2 - Oral intake of 1 g of powder containing killed lactic acid bacteria once daily for 4 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - 1.Healthy working adults aged 30 years or older and younger than 65 years at the time of obtaining consent
2.Subjects who feel stress in their daily work or life and routinely experience anxiety or mental fatigue
3.Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail
Key exclusion criteria - 1.Subjects with a history of gastric of lower gastrointestinal surgery (without hemorrhoid surgery, polypectomy, and appendectomy)
2.Subjects who participated in another clinical study within 1 month before informed consent, are currently participating in one, or plan to do so during the study period
3.Subjects scheduled for an upper gastrointestinal barium X-ray, small intestinal endoscopy, colonoscopy, or colon cleansing (at a clinic or at home) between screening and the end of the study
4.Subjects planning to use, even once, medications that may affect the study between screening and the end of the study
5.Subjects with a Self-Rating Depression Scale (SDS) score of 60 or higher
6.Subjects with a current or past psychiatric disorder, or receiving treatment, medication, lifestyle guidance, or counseling for one
7.Subjects with other serious or progressive diseases
8.Subjects unable to stop consuming foods or supplements that may affect the study between screening and the end of the study
9.Smokers
10.Subjects consuming more than 40 g of pure alcohol per day on average
11.Subjects with irregular daily rhythms due to night or shift work
12.Subjects expecting major changes in their home or work environment (e.g., relocation, job transfer, or job change) during the study period
13.Subjects planning overseas travel, or travel or business trips longer than 1 week, during the study period
14.Subjects with self-perceived severe menstrual symptoms (e.g., physical discomfort, depressed mood, irritability, or anxiety)
15.Subjects who are pregnant, breastfeeding, or planning pregnancy during the study period
16.Subjects with food allergies
17.Subjects judged ineligible by the principal investigator
Target Size - 90
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2026 Year 09 Month 18 Day
Date of IRB - 2026 Year 09 Month 18 Day
Anticipated trial start date - 2026 Year 11 Month 21 Day
Last follow-up date - 2026 Year 12 Month 21 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072257
Disclaimer: Curated by HT Syndication.
