UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000039553
Receipt number R000045104
Scientific Title Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)
Date of disclosure of the study information 2021/05/31
Last modified on 2020/02/20 19:40:23

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Basic information

Public title

Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)

Acronym

Trial of the efficacy of food ingredients on sleep quality in healthy men and women

Scientific Title

Trial of the efficacy of food ingredients on sleep quality in healthy men and women (SWE-2019-10)

Scientific Title:Acronym

Trial of the efficacy of food ingredients on sleep quality in healthy men and women

Region

Japan


Condition

Condition

Not applicable

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate the effect of food ingredients on sleep quality

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Sleep quality

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

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

3

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Intake of the test foods A (8 weeks)

Interventions/Control_2

Intake of the test foods B (8 weeks)

Interventions/Control_3

Intake of the control foods (8 weeks)

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

40 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

1) Women and men aged 40 to 64 years.
2) Person who feels poor sleep quality.
3) Person who gets a score of 6 or higher in the Japanese version of the Pittsburgh Sleep Quality Index
4) Person who can come to the medical and inspection organizations for the measurement at the date of visiting.
5) Person who can understand the purpose and content of this study and agree in writing to participate in this study.

Key exclusion criteria

1) Person who are living irregularly
2) Person whose engage in shift work.
3) Use of product affecting the data of this study, such as food for specified health use, food with function claims, and medicine.
4) Presence of previous and present disease such as insomnia, sleep apnea syndrome, mental disorder, lung disorder, cardiovascular disorder, diabetes mellitus, food allergy.
5) Investigator's judgment for other reason.

Target sample size

90


Research contact person

Name of lead principal investigator

1st name Norifumi
Middle name
Last name Tateishi

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute For Health Care Science

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0655

Email

Norifumi_Tateishi@suntory.co.jp


Public contact

Name of contact person

1st name Masaru
Middle name
Last name Kominami

Organization

SUNTORY WELLNESS LIMITED

Division name

Institute For Health Care Science

Zip code

619-0284

Address

8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan

TEL

050-3182-0667

Homepage URL


Email

Masaru_Kominami@suntory.co.jp


Sponsor or person

Institute

SUNTORY WELLNESS LIMITED

Institute

Department

Personal name



Funding Source

Organization

SUNTORY WELLNESS LIMITED

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F SANWA UCHIKANDA Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo, Japan

Tel

03-5297-5548

Email

IRB@cpcc.co.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 05 Month 31 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


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

Preinitiation

Date of protocol fixation

2020 Year 01 Month 17 Day

Date of IRB


Anticipated trial start date

2020 Year 04 Month 08 Day

Last follow-up date

2020 Year 06 Month 10 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 02 Month 20 Day

Last modified on

2020 Year 02 Month 20 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045104


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name