Tokyo, July 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000055109) titled 'Evaluation of the impact of the probiotic-containing dairy product on daytime work performance' on July 30.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - CPCC Company Limited
Condition:
Condition - Male/female adults
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the impact of continuous intake of the probiotic-containing dairy product on daytime work performance.
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Consumption of the test food (1 bottle a day) for 8 weeks
Interventions/Control_2 - Consumption of the placebo food (1 bottle a day) for 8 weeks
Eligibility:
Age-lower limit - 30
years-old
Gender - Male and Female
Key inclusion criteria - 1. Office workers
2. Subjects who are having sleep dissatisfaction
3. Subjects whose average sleep time on weekdays falls within the range of 4 to 7 hours
4. Right-handed subjects
5. Subjects who give written informed consent, after receiving a detailed explanation about the study and understanding the provided information.
Key exclusion criteria - 1. Subjects who have any clinically significant diseases, disorders or allergies to foods and drugs which in the investigator's opinion could interfere with the safety of study participants or with the results of the study.
2. Subjects who are currently receiving drug treatment.
3. Subjects who are trying to improve stress, sleep, and fatigue by taking functional foods or receiving therapies.
4. Subjects who are in living condition that can disturb their own sleep.
5. Subjects who have smoking habits.
6. Subjects who daily take excessive alcohol.
7. Subjects who work on irregular shifts or are engaged in physical labor.
8. Subjects who have exercise habits during nighttime and are unable to finish an exercise by 2 hours before bedtime.
9. Subjects whose sleeping environment is likely to change significantly during the study period due to a long trip or some others.
10. Subjects having wounds or other conditions on the area where the brain activity measuring device is to be attached
11. Subjects who have a participation in another interventional clinical study within the last 4 weeks or are intended to participate.
12. Females who are pregnant, intend to become pregnant, or breast-feeding.
13. Others who have been considered ineligible for the participation in the study by the investigators.
Target Size - 120
Recruitment Status:
Recruitment status - Completed
Date of protocol fixation - 2024 Year 07 Month 22 Day
Date of IRB - 2024 Year 07 Month 19 Day
Anticipated trial start date - 2024 Year 07 Month 31 Day
Last follow-up date - 2025 Year 01 Month 01 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062665
Disclaimer: Curated by HT Syndication.
