UMIN-CTR Clinical Trial

Public title

Effects of a carbohydrate-restricted diet on concentration

Acronym

Effects of a carbohydrate-restricted diet on concentration

Scientific Title

Effects of a carbohydrate-restricted diet on concentration

Scientific Title:Acronym

Effects of a carbohydrate-restricted diet on concentration

Region

Japan

Condition

Not applicable

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Investigate the effects of a low-carbohydrate diet on sleepiness, concentration, and glucose levels using a high-carbohydrate diet as a control.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Eye blink

Key secondary outcomes

VAS, glucose levels, concentration test, finger pulse wave measurement, surface and deep body temperature

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is 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 low-carbohydrate diet (single ingestion) - washout period - Intake of a high-carbohydrate diet (single ingestion)

Interventions/Control_2

Intake of a high-carbohydrate diet (single ingestion) - washout period - Intake of a low-carbohydrate diet (single ingestion)

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

59

years-old

>=

Gender

Male and Female

Key inclusion criteria

(1) Males and females aged between 20 and 59
(2) Subjects who tend to feel sleepy after lunch
(3) Subjects whose blood glucose level is less than 126 mg/dL at the time of preliminary examination

Key exclusion criteria

(1) Subjects who have been diagnosed with strabismus or astigmatism
(2) Subjects who wear eyeglasses, hard contact lenses, or define contact lenses
(3) Subjects who has a history of eye disease within the past six months
(4) Subjects who has a history of eye surgery within the past six months
(5) Subjects who usually wear false eyelashes, eyelash extensions, mascara, or eye makeup, and cannot remove them on the day of the examination
(6) Subjects who do not meet the visual acuity requirements for blink eye measurement
(7) Subjects with pacemakers or other implantable medical devices
(8) Subjects who are unable to perform PC operations or finger pulse wave measurement and other tests according to procedure due to injury or other reasons
(9) Subjects who regularly use food for specified health use or food with functional claims related to blood glucose levels
(10) Subjects who are judged as unsuitable for the study based on the medical history
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects who have diseases that require constant medication, or who have a history of serious diseases that required medication treatment
(13) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(14) Subjects who are participating in other clinical research at the start of this study
(15) Subjects who intend to become pregnant or lactating during the research period
(16) Subjects who judged as unsuitable for the study by the investigator for other reasons

Target sample size

30

Name of lead principal investigator

1st name	Hiroshi
Middle name
Last name	Kawabata

Organization

Ezaki Glico Co., Ltd.

Division name

R&D LABORATORY

Zip code

555-8502

Address

4-6-5, Utajima, Nishiyodogawa-ku, Osaka

TEL

090-5241-7900

Email

hiroshi.kawabata@glico.com

Name of contact person

1st name	Hiroyasu
Middle name
Last name	Shimada

Organization

EP Mediate Co., Ltd.

Division name

Foods Department, Trial Planning Section

Zip code

162-0822

Address

Turuya Bldg.,2-23, Shimomiyabicho, Shinjuku-ku, Tokyo

TEL

090-5219-2774

Homepage URL

Email

shimada.hiroyasu767@eps.co.jp

Institute

EP Mediate Co., Ltd.

Institute

Department

Personal name

Organization

Ezaki Glico Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Medical Station Clinic Research Ethics Committee

Address

3-12-8, Takaban, Meguro-ku, Tokyo

Tel

03-6452-2712

Email

nakagawa.akiko297@eps.co.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

2021

Year

12

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

28

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

2021

Year

11

Month

25

Day

Date of IRB

2021

Year

11

Month

25

Day

Anticipated trial start date

2021

Year

12

Month

08

Day

Last follow-up date

2022

Year

01

Month

24

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2021

Year

12

Month

01

Day

Last modified on

2023

Year

12

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052780