Tokyo, April 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061292) titled 'A study to investigate the effect of a vegetable extract on sleep quality' on April 17.

Study Type: Interventional

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

Primary Sponsor: Institute - S'UIMIN Inc.

Condition: Condition - healthy person Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The objective of this study is to investigate the effect of consuming a standardized extract of Asparagus officinalis stem on sleep quality in individuals who have been assessed as having poor sleep quality, based on sleep tests using an electroencephalography (EEG) device and a sleep assessment questionnaire. The assessment of sleep in the planned crossover study shall be conducted through sleep monitoring with a EEG device, monitoring of sympathetic nervous system activity with a pulse wave monitor, and subjective sleep evaluations using the questionnaire. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - During the intervention period, Group A (25 participants) will consume their assigned test food: either asparagus stem extract or a placebo, daily after dinner (with no intake during the washout period) and will keep a daily intake log. In addition, participants will complete daily questionnaires regarding daytime activities and sleep throughout the intervention period. From days 8 to 14 of the intervention period, objective sleep assessments will be conducted using EEG and other bioelectric potential measurements from bedtime to wake-up time, and subjective sleep assessments using a pre-sleep questionnaire and the Upon Awakening Sleep Quality Questionnaire (OSA-MA) will be conducted for 7 consecutive days. On the morning of the final day of the 7-day sleep assessment period, subjective assessments of sleep status over the past month (Athens Insomnia Scale, Epworth Sleepiness Scale) will be administered. A pulse wave monitor will be worn and record throughout the day during the intervention period. Interventions/Control_2 - During the intervention period, Group B (25 participants) will consume their assigned test food: either asparagus stem extract or a placebo, daily after dinner (with no intake during the washout period) and will keep a daily intake log. In addition, participants will complete daily questionnaires regarding daytime activities and sleep throughout the intervention period. From days 8 to 14 of the intervention period, objective sleep assessments will be conducted using EEG and other bioelectric potential measurements from bedtime to wake-up time, and subjective sleep assessments using a pre-sleep questionnaire and the Upon Awakening Sleep Quality Questionnaire (OSA-MA) will be conducted for 7 consecutive days. On the morning of the final day of the 7-day sleep assessment period, subjective assessments of sleep status over the past month (Athens Insomnia Scale, Epworth Sleepiness Scale) will be administered. A pulse wave monitor will be worn and record throughout the day during the intervention period.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals capable of expressing their own consent. Individuals whose average percentage of N3 stage sleep was less than 10%. Individuals without any specific medical restrictions. Individuals capable of adequate oral intake of the test foods. Individuals whose time in bed exceeds five hours, calculated from their declared regular bedtime and wake-up time. Individuals who work day shifts from Monday to Friday (excluding those on rotating shift schedules such as early or late shifts) .Individuals who are able to perform the following during the intervention periods - Consumption of the test foods (including placebos) - EEG measurement with an EEG device - Pulse wave measurement with a pulse wave monitor - Complete questionnaires regarding sleep and related factors Individuals who are able to perform the following during the EEG measurement periods. - Adherence to a flexible sleep schedule which requires going to sleep within 2 hours before or after their reported bedtime and waking up within 2 hours before or after their reported wake-up time - Avoidance of the consumption of alcohol or caffeinated beverages within 4 hours before bedtime - Sleeping alone in a bed Individuals who are able to provide their own smartphone (iPhone or Android) or personal computer. Key exclusion criteria - Individuals who cannot understand Japanese. Individuals who previously consented to participate in this study and subsequently withdrew their consent or declined to continue participating. Individuals who have provided consent and deemed unsuitable for inclusion by the principal investigator or co-investigators. Individuals with severe drug allergies or severe food allergies. Individuals who are currently participating in or planning to participate in other clinical trials involving the consumption of food or clinical trials related to sleep during the intervention periods Individuals with a BMI of 25 or higher (obesity class 1 or higher as defined by the Japan Society for the Study of Obesity) Individuals with severe anemia, cardiovascular disease, respiratory disease, liver disease, kidney disease, gastrointestinal disease, diabetes, rheumatoid arthritis, acute infectious diseases, mental disorders, cerebrovascular disorders, benign prostatic hyperplasia, nocturia, or overactive bladder symptoms. Individuals currently undergoing treatment for insomnia or sleep disorders. Individuals regularly taking medications believed to affect sleep. Pregnant women, breastfeeding women, or women who may be pregnant. Individuals living with a person requiring long-term care and primarily responsible for providing that care. Individuals with a habit of excessive smoking. Individuals with a habit of consuming large amounts of beverages containing alcohol or caffeine. Target Size - 50

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 02 Month 17 Day Date of IRB - 2026 Year 02 Month 25 Day Anticipated trial start date - 2026 Year 04 Month 20 Day Last follow-up date - 2026 Year 07 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070132

Disclaimer: Curated by HT Syndication.