UMIN-ICDS Clinical Trial

Public title

A study to investigate the effect of a vegetable extract on sleep quality

Acronym

A study to investigate the effect of a vegetable extract on sleep

Scientific Title

A double-blind randomized controlled crossover study to investigate the effect of a vegetable extract intake on sleep quality

Scientific Title:Acronym

A double-blind crossover study to investigate the effect of a vegetable extract on sleep quality

Region

Japan

Condition

healthy person

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Sleep EEG Measurement
-Proportion of slow-wave sleep (N3)

Key secondary outcomes

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

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

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.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

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 sample size

50

Name of lead principal investigator

1st name	Jun
Middle name
Last name	Takanari

Organization

Amino Up Co., Ltd.

Division name

Business Development Division Academic Affairs

Zip code

004-0839

Address

363-32 Shin-ei, Kiyota, Sapporo, Hokkaido, 0040839, JAPAN

TEL

011-889-2555

Email

takanari@aminoup.jp

Name of contact person

1st name	Shuji
Middle name
Last name	Nakamura

Organization

S'UIMIN Inc.

Division name

Business Division

Zip code

151-0061

Address

817 Hatsudai Center Building, 1-51-1 Hatsudai, Shibuya-ku, Tokyo 151-0061, Japan

TEL

03-6276-3662

Homepage URL

Email

biz-cro@suimin.co.jp

Institute

S'UIMIN Inc.

Institute

Department

Personal name

Organization

Amino Up Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Medical Institutions Sapporo Yuurinokai Hospital Clinical Trials Committee

Address

11-186 Yurigahara, Kita-ku, Sapporo, Hokkaido

Tel

011-771-1501

Email

info@yurinokai.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2026

Year

04

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

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

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2026

Year

04

Month

17

Day

Last modified on

2026

Year

04

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070132