Tokyo, Oct. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059358) titled 'A randomized, double-blind, placebo-controlled, parallel-group study to investigate the effect of continuous ingestion of Euglena gracilis EOD-1 strain on sleep in healthy adult men and women' on Oct. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - Seiichiro Aoe

Otsuma Women's University

Faculty of Home Economics, Department of Food Science

Condition: Condition - Healthy adult men and women aged 20 to 69 Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to investigate the effect of continuous intake of Euglena gracilis EOD-1 strain on sleep in healthy adult men and women for three weeks in a randomized, double-blind, placebo-controlled, parallel-group study. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Two capsules containing 500 mg of microcrystalline cellulose instead of Euglena gracilis EOD-1 strain will be taken after dinner once a day for three weeks. Interventions/Control_2 - Two capsules containing 500 mg of Euglena gracilis EOD-1 strain will be taken after dinner once a day for three weeks.

Eligibility: Age-lower limit - 20 years-old = Gender - Male and Female Key inclusion criteria - Healthy individuals Ages 20 and over and 69 and under Those who are aware of their sleep problems Key exclusion criteria - 1. Subjects with a history of or current respiratory, digestive, hepatobiliary, pancreatic, hematological, renal, endocrine, or cardiovascular disease. 2. Subjects with a history of serious trauma or surgery within 12 weeks prior to the start of the study. 3. Subjects with a history or suspected food or drug allergies requiring treatment. 4. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are regularly using supplements or health foods related to sleep quality. 5. Subjects who, during the subject explanation, the principal investigator or co-researcher determines are taking actions aimed at improving sleep, fatigue, or stress. 6. Subjects who experience nighttime awakenings due to nocturnal urination, etc. 7. Subjects who have been diagnosed with sleep apnea syndrome or chronic fatigue syndrome. 8. Subjects who are allergic to the test food. 9. Subjects who have participated in other clinical trials (including clinical trials) within 4 weeks prior to the start of the study. Other subjects who the principal investigator determines are unsuitable as subjects. Target Size - 40

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 07 Month 15 Day Date of IRB - 2025 Year 07 Month 15 Day Anticipated trial start date - 2025 Year 10 Month 30 Day Last follow-up date - 2025 Year 12 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067664

Disclaimer: Curated by HT Syndication.