UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000050439
Receipt number R000057446
Scientific Title Verification of the efficacy of the foods intake in VDT work in healthy adults. - A randomized, double-blind, placebo-controlled, crossover study-
Date of disclosure of the study information 2023/02/27
Last modified on 2024/09/09 13:47:30

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Basic information

Public title

Verification of the efficacy of test foods intake in VDT work in healthy adults.

Acronym

Verification of the efficacy of test foods intake in VDT work in healthy adults.

Scientific Title

Verification of the efficacy of the foods intake in VDT work in healthy adults. - A randomized, double-blind, placebo-controlled, crossover study-

Scientific Title:Acronym

Verification of the efficacy of the foods intake in VDT work in healthy adults.

Region

Japan


Condition

Condition

Healthy subjects

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose is to verify the effectiveness of test food intake in VDT work in healthy adults.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

EEG, scores associated with VDT tasks, subjective evaluation(POMS2)

Key secondary outcomes



Base

Study type

Interventional


Study design

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



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

A single administration of the test food is performed. After a washout period, a single administration of placebo is performed.

Interventions/Control_2

A single administration of the placebo is performed. After a washout period, a single administration of test food is performed.

Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1. healthy men and women between the ages of 18 and 65 at the time of obtaining written consent
2. people who perform VDT work on a daily basis

Key exclusion criteria

a. taking medication or under medical treatment
b. pregnant, lactating, or intending to become pregnant during the study period
c. Minors (under 18 years of age)
d. under exercise therapy or dietetic therapy
e. allergic to test food
f. current dependence or history of either medicine or alcohol dependence syndrome
g. current or prior diagnosis of mental illness (depression) or sleep disturbance
h. extremely irregular lifestyle
i. on a night-shift or shift worker
j. unbalanced diet
k. current disease or history of brain disease, malignant tumor, immunological disease, diabetes, renal disease, cardiac disease, thyroid disease, adrenal disease, or other metabolic disease.
l. use of health foods, supplements, and medicines
m. participation in other clinical studies within the past 3 months from the day of consent or planning to participate in other clinical studies during the current study; n. considered as an inappropriate candidate by the doctor in charge.

Target sample size

9


Research contact person

Name of lead principal investigator

1st name Ryousuke
Middle name
Last name Furukado

Organization

NISHINIPPON INSTITUTE OF TECHNOLOGY

Division name

Faculty of Engineering

Zip code

8000344

Address

1-11 Aratsu Kanda-machi Miyako-gun Fukuoka Japan

TEL

0930-23-1491

Email

furukado@nishitech.ac.jp


Public contact

Name of contact person

1st name Keita
Middle name
Last name Koga

Organization

Pharma Foods International Co., Ltd.

Division name

Research and Development

Zip code

6158245

Address

1-49, Goryo-ohara, nishikyo-ku, Kyoto city, Kyoto, Japan

TEL

075-748-9829

Homepage URL


Email

k-koga@pharmafoods.co.jp


Sponsor or person

Institute

Pharama Foods International Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Pharama Foods International Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committees of LittleSoftware

Address

PLACEO Aoyama 3F, 2-7-13, Kita-Aoyama, Minato-ku, Tokyo, Japan

Tel

03-3789-6083

Email

hhara@littlesoftware.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 02 Month 27 Day


Related information

URL releasing protocol

https://center6.umin.ac.jp/cgi-open-bin/icdr/ctr_view.cgi?recptno=R000057446

Publication of results

Published


Result

URL related to results and publications

https://www2.aeplan.co.jp/jsnfs2024/document/program.pdf

Number of participants that the trial has enrolled

9

Results

Statistically significant difference was confirmed in the primary outcome.

Results date posted

2024 Year 09 Month 09 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

1. healthy men and women between the ages of 18 and 65 at the time of obtaining written consent
2. people who perform VDT work on a daily basis

Participant flow

Enrolled(n=9)
Completed(n=9)
Analyzed(n=8)

Adverse events

No adverse events were observed that be related to test food.

Outcome measures

EEG, scores associated with VDT tasks, subjective evaluation 

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2023 Year 02 Month 17 Day

Date of IRB

2023 Year 02 Month 21 Day

Anticipated trial start date

2023 Year 02 Month 28 Day

Last follow-up date

2023 Year 05 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 02 Month 27 Day

Last modified on

2024 Year 09 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057446