Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058362) titled 'Randomized, double-blind, placebo-controlled parallel-group comparative study to evaluate the efficacy of the bifidobacteria on sleep quality' on July 7.
Study Type:
Interventional
Study Design:
Basic Design - Parallel
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Placebo
Primary Sponsor:
Institute - Yamaguchi Health Lab
Condition:
Condition - None
Classification by malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effect of the bifidobacteria on sleep quality in adults with sleep quality concerns
Basic objectives2 - Safety,Efficacy
Intervention:
Interventions/Control_1 - Oral ingestion of the test food for 8 weeks
Interventions/Control_2 - Oral ingestion of the placebo food for 8 weeks
Eligibility:
Age-lower limit - 20
years-old
Gender - Male and Female
Key inclusion criteria - 1) Participants aged more than 20 years, less than 65 years.
2) Participants with a total score of 6 or higher on the Pittsburgh Sleep Questionnaire
Key exclusion criteria - 1)Participants with a serious disease or a history of a serious disease
2)Participants with a history or current history of insomnia, psychiatric disorders, drug dependence, or alcohol dependence
3)Participants who have been diagnosed with sleep apnea syndrome or suspected sleep apnea syndrome (including those being treated with CPAP)
4)Participants who are currently undergoing treatment for sleep, stress, or fatigue, or using medications related to sleep, stress, or fatigue
5)Participants who cannot discontinue intake of food for specified health use, food with functional claims, food with nutrient function claims, supplements, etc. that may affect sleep during the study period
6)Participants who cannot discontinue intake of foods or supplements containing lactobacilli, bifidobacteria, oligosaccharides, etc. during the study period
7)Participants who cannot discontinue intake of caffeine-rich food and beverages, alcohol, or smoking during the period of EEG measurement from 4 hours before bedtime to sleep
8)Excessive alcohol drinkers
9)Excessive smorkers
10)Participants who have more than 3 interruptions of sleep due to urination
11)Participants who do not have fixed days off, who work day and night shifts, and who work shift work (excluding participants who have a fixed work schedule per week as housewives, part-time workers, etc.)
12)Participants who plan to travel abroad during the study period
13)Participants who are participating or intend to participate in other tests
14)Participants with a history of drug allergy or food allergy
15)Participants who may experience allergic symptoms during the study period, or who are using or intend to use drugs for allergic symptoms
16)Pregnant women, intending mothers, and lactating mothers
17)Participants with sensitive skin who may develop skin irritation from adhesive plasters or adhesive tapes
18)Participants who are judged to be inappropriate for this study by the principal investigator or the examination doctor
Target Size - 100
Recruitment Status:
Recruitment status - Preinitiation
Date of protocol fixation - 2025 Year 06 Month 09 Day
Date of IRB - 2025 Year 06 Month 20 Day
Anticipated trial start date - 2025 Year 07 Month 14 Day
Last follow-up date - 2025 Year 12 Month 31 Day
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066721
Disclaimer: Curated by HT Syndication.
