UMIN-CTR Clinical Trial

Public title

A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

Acronym

A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

Scientific Title

A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

Scientific Title:Acronym

A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females

Region

Japan

Condition

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to evaluate the effects of intake of GABA-containing food for 2 consecutive weeks on stress, sleep quality, fatigue, and electroencephalography during sleep compared to placebo.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Stress: POMS 2-A Short
Sleep: electroencephalography

Key secondary outcomes

Fatigue: Fatigue VAS
Sleep: OSA Sleep Inventory for Middle-Aged and Aged

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

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

Intake of a GABA - containing food for 2 consecutive weeks - washout period of 2 weeks - intake of placebo for 2 consecutive weeks

Interventions/Control_2

Intake of placebo for 2 consecutive weeks - washout period of 2 weeks - intake of a GABA-containing food for 2 consecutive weeks

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

30

years-old

<=

Age-upper limit

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Male and female workers from 30 to 59 years of age
2) Pittsburgh sleep quality index global score is greater than or equal to 6
3) POMS 2-AS FI T score is greater than or equal to 50 and VA T score is less than or equal to 50

Key exclusion criteria

1) Subjects who routinely use food or medicine containing of GABA
2) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress
3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue
4) Subjects who wake after sleep onset for nocturia twice and more than twice a week
5) Subjects who have a possibility of feeling stress and affecting sleep due to abstinence
6) Subjects who have a history of hay fever
7) Night and day shift worker or manual laborer
8) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor
9) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome
10) Subjects who have had a diagnosis of chronic fatigue syndrome
11) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion
12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires
13) Subjects having possibilities for emerging allergy related to the study
14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
16) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
17) Subjects who are judged as unsuitable for the study by the investigator for other reasons

Target sample size

32

Name of lead principal investigator

1st name
Middle name
Last name	Hideki Hokazono

Organization

Sanwa Shurui Co., Ltd.

Division name

Research Laboratory

Zip code

Address

2231-1, Yamamoto, Usa, Oita

TEL

0978-33-3844

Email

hokazono-h@kokuzo.co.jp

Name of contact person

1st name
Middle name
Last name	Hiroyasu Shimada

Organization

TTC Co., Ltd.

Division name

Clinical Research Planning Department

Zip code

Address

1-20-2, Ebisunishi, shibuya-ku, Tokyo

TEL

03-5459-5329

Homepage URL

Email

h.shimada@ttc-tokyo.co.jp

Institute

TTC Co.,Ltd.

Institute

Department

Personal name

Organization

Sanwa Shurui Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2017

Year

03

Month

24

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

Number of participants that the trial has enrolled

Results

GABA significantly decreased the total non-rapid eye movement (non-REM) sleep stage 2. In stratified analysis based on stress, the total time of non-REM sleep stage 3 in the layer above the mean value of confusion-bewilderment, anger-hostility, tension-anxiety, total mood disturbance score of the Profile of Mood States 2nd edition (POMS2) were significantly increased in the GABA intake period compared to the placebo. In stratified analysis by fatigue feeling, the total time of non-REM sleep stage 3 at the time of ingesting GABA in the layer where the fatigue VAS prior to ingestion exceeded the average value significantly increased compared to placebo. Stratified analysis based on age, the total time of non-REM sleep stage 3 at the time of ingestion of GABA in the stratum above the average age was significantly increased compared to placebo.

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

Completed

Date of protocol fixation

2017

Year

03

Month

23

Day

Date of IRB

Anticipated trial start date

2017

Year

03

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

03

Month

23

Day

Last modified on

2018

Year

06

Month

07

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030558