UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044556
Receipt number R000050751
Scientific Title The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders
Date of disclosure of the study information 2021/06/16
Last modified on 2022/12/13 12:24:04

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders

Acronym

The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders

Scientific Title

The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders

Scientific Title:Acronym

The effects of long-term intake of potato made in Nagasaki on improvement of mild physical and mental disorders

Region

Japan


Condition

Condition

Healthy adult

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Investigation of improving effects of mild physical and mental disorders by ingesting potatoes

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Vas questionaire
eye strain, sleep quality, stress, constipation and fatigue
Visceral fat area

Key secondary outcomes

Blood components, brain waves, heart beat


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation


Institution consideration

Institution is not considered as adjustment factor.

Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects ingest the placebo meal for eight weeks

Interventions/Control_2

The subjects ingest the active meal for eight 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



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Individuals who understand the purpose and contents of the experiment
2)Healthy male and female between 20 and 79 years old
3)Subjects who not are contracting or treating serious cerebrovascular disease and/or heart disease and/or liver diseases and/or digestive disease and/or infectious diseases that need to be reported

Key exclusion criteria

1)Pregnant women, or women with intending to become pregnant, and lactating woman
2)Individuals judged by the doctor to be unsuitable
3)Person who donated more than 400 ml of blood within 3 months prior to the study
4)Individuals participating or intending to participate in a drug administration test


Target sample size

60


Research contact person

Name of lead principal investigator

1st name Kazunari
Middle name
Last name Tanaka

Organization

Univercity of Nagasaki

Division name

Regional Partnership Center

Zip code

8512195

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

0958135216

Email

katanaka@sun.ac.jp


Public contact

Name of contact person

1st name Hideki
Middle name
Last name Ito

Organization

Univercity of Nagasaki

Division name

Regional Partner Center

Zip code

8512195

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

TEL

0958135500

Homepage URL


Email

hito@sun.ac.jp


Sponsor or person

Institute

Univercity of Nagasaki

Institute

Department

Personal name



Funding Source

Organization

Cabinet Office

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Univercity of Nagasaki

Address

1-1-1 Manabino, Nagayo-cho, Nishisonogi-gun, Nagasaki, Japan, 851-2195

Tel

0958135216

Email

katanaka@sun.ac.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

2021 Year 06 Month 16 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

60

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



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 03 Month 20 Day

Date of IRB

2021 Year 04 Month 13 Day

Anticipated trial start date

2021 Year 05 Month 15 Day

Last follow-up date

2021 Year 08 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 16 Day

Last modified on

2022 Year 12 Month 13 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name