UMIN-ICDS Clinical Trial

Public title

Effects of L-theanine and GABA on sleep

Acronym

Effects of L-theanine and GABA on sleep

Scientific Title

Before-after study on the effects of L-theanine and GABA on sleep in adults with sleep problems.

Scientific Title:Acronym

Before-after study on the effects of L-theanine and GABA on sleep

Region

Japan

Condition

Healthy adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Evaluation of sleep quality before and after L-theanine and GABA intake.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Pittsburgh sleep quality index

Key secondary outcomes

State-Trait Anxiety Inventory
Health-related data collected by Fitbit Charge 5
Adverse event

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

L-theanine 200mg/day, gamma-aminobutyric acid 700mng/day for 4weeks

Interventions/Control_2

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

20

years-old

<=

Age-upper limit

64

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Females/males aged between 20 and 64 years who are aware of problems related to sleep.
(2) Those with a BMI of between 18.5 and 25.0 kg/m2.
(3) Those with a score of 6 or more on the Pittsburgh sleep quality index.
(4) Those who are able to wear Fitbit Charge 5 during the study period, including at bedtime.
(5) Those who can give written voluntary consent to participate in the study.

Key exclusion criteria

(1) Those who are currently diagnosed with insomnia or sleep disorders and are undergoing some kind of medical treatment.
(2) Those who consume food or supplements containing L-theanine or gamma-aminobutyric acid.
(3) Those who regularly use health foods or supplements that affect sleep.
(4) Those with serious diseases such as glucose metabolism related disease, lipid metabolism related disease, liver disease, renal disease, cardiovascular disease, gastrointestinal disease, respiratory disease, hematological disease, autoimmune disease, endocrine system disease, metabolic system disease. Or those with a history of such diseases.
(5) Those with a history of drug allergy or serious food allergy.
(6) Those who have had abnormal laboratory values within the past year and have been considered to have problems participating in the study.
(7) Those who have a disease that is currently undergoing medical visit, medical treatment, use of medication, or follow-up.
(8) Those who are considered to be inappropriate as subjects based on the results of the questionnaire on the background of the subjects.
(9) Those who are participating in other clinical studies at the start of this study.
(10) Those who are pregnant or plan to become pregnant or breastfeed during the study period.
(11) Those who are considered inappropriate to participate in the study by the study investigator (or the person in charge of the contract research organization).

Target sample size

20

Name of lead principal investigator

1st name	Hiroyuki
Middle name
Last name	Konno

Organization

Japan Brain-Care Dementia Prevention Research Center

Division name

-

Zip code

160-0022

Address

2F Shiratori Building, 1-2, Shinjuku 2-chome, Shinjuku-ku, Tokyo

TEL

03-6910-0797

Email

hiro@brain-care-dementia.jp

Name of contact person

1st name	Kazumi
Middle name
Last name	Naganuma

Organization

DRC Co., LTD.

Division name

Cosmetics and Food Usefulness Test Group, Testing Department

Zip code

530-0044

Address

The 9th Tabuchi Bldg. 3F, 2-10-31 Higashi-Temma, Kita-ku, Osaka

TEL

06-6882-1130

Homepage URL

Email

naganuma@drc-web.co.jp

Institute

Hiroyuki Konno, Japan Brain-Care Dementia Prevention Research Center.

Institute

Department

Personal name

Organization

Nestle Japan Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Brain Care Clinic Ethics Review Committee

Address

2F Shiratori Building, 1-2, Shinjuku 2-chome, Shinjuku-ku, Tokyo

Tel

03-6910-0797

Email

info@brain-care-dementia.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

2023

Year

03

Month

24

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

Completed

Date of protocol fixation

2023

Year

02

Month

03

Day

Date of IRB

2023

Year

02

Month

03

Day

Anticipated trial start date

2023

Year

03

Month

12

Day

Last follow-up date

2023

Year

06

Month

01

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

03

Month

17

Day

Last modified on

2023

Year

09

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057652