healthy person
Conditions
Interventions
During the intervention period, Group A (25 participants) will consume their assigned test food: either a vegetable extract or a placebo, daily after dinner (with no intake during the washout period)
Sponsors
S'UIMIN Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep EEG Measurement -Proportion of slow-wave sleep (N3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sleep EEG Measurement -Total time of slow-wave sleep -total time and percentage of REM sleep -sleep efficiency, WASO, sleep latency, total sleep time, time in bed after final awakening -duration of sleep stages -REM latency Sleep questionnaires -OSA-MA, AIS, ESS Heart Rate Variability Analysis -LF/HF (in awake before sleep-onset, awake after sleep-onset, and slow-wave sleep) Adverse events | — |
Countries
Japan
Contacts
Public ContactShuji Nakamura
S'UIMIN Inc. Business Division
Outcome results
None listed