UMIN-CTR Clinical Trial

Public title

Effect of the Test Food Containing Crocetin on the Quality of Sleep

Acronym

Effect of the Test Food Containing Crocetin on the Quality of Sleep

Scientific Title

Effect of the Test Food Containing Crocetin on the Quality of Sleep

Scientific Title:Acronym

Effect of the Test Food Containing Crocetin on the Quality of Sleep

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aims to examine the effect of the test food containing crocetin on the quality of sleep.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Electroencephalography measurement with SleepScope (Week 0, 2nd week of the observation period I, 2nd week of the observation period II)
[2]OSA sleep inventory (Screening, Week 0, 2nd week of the observation period I, 2nd week of the observation period II)

Key secondary outcomes

*Safety
[1]Blood pressure (Screening, 2nd week of the observation period I, 2nd week of the observation period II)
[2]Weight, body fat percentage, BMI (Screening, 2nd week of the observation period I, 2nd week of the observation period II)
[3]Doctor's questions (Screening, 2nd week of the observation period I, 2nd week of the observation period II)
[4]Subject's diary (From the first day of ingestion of a test material to the last day of the test)

*Other indexes
[1]Blood test (Screening)
[2]Blood biochemical test (Screening)
[3]Urine analysis (Screening)
[4]Pittsburgh Sleep Quality Index (PSQI-J) (Screening)

Study type

Interventional

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

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test food (1 pill in a day; 2 weeks)
>Washout period (2 weeks)
>Oral intake of the placebo food (1 pill in a day; 2 weeks)

Interventions/Control_2

Oral intake of the placebo food (1 pill in a day; 2 weeks)
>Washout period (2 weeks)
>Oral intake of the test food (1 pill in a day; 2 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

Age-lower limit

35

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

[1]Males aged 35-60 years of Postmenopausal females aged 35-60 years.
[2]Individuals who are healthy and don't receive treatment.
[3]Individuals who fell fatigued, are bad falling asleep, or sleep badly.
[4]Individuals whose lights-out and weak-up time is regular, light-out time is before 0 AM, and time of sleeping is over 4 hours.
[5]Individuals who work on daytime from Monday to Friday and have Saturdays and Sundays off.
[6]Individuals whose written informed consent has been obtained.
[7]Individuals judged appropriate for the trial by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who use a drug for treatment of disease.
[3]Individuals who are suspected patient of, a patient of, or had a history of sleep apnea syndrome.
[4]Individuals who have or are suspected patient of nocturia, benign prostatic hyperplasia, overactive bladder.
[5]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[6]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C.
[7]Individuals who have a history of digestive system disease.
[8]Individuals whose BMI is over 25.
[9]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day).
[10]Individuals who are a smoker.
[11]Individuals with serious anemia.
[12]Individuals who are sensitive to a test product or other foods, and medical products.
[13]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 1 month or will ingest those foods during the test period.
[14]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[15]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[16]Individuals who participated in other clinical studies in the past 3 months.
[17]Individuals who are sensitive to the electrode pad.
[18]Individuals who are or whose family is a employee of a health food, functional food, or cosmetic company.
[19]Individuals judged inappropriate for the trial by the principal.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Atsuko Mori

Organization

Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Division name

Head of center

Zip code

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005

TEL

03-5816-0711

Email

ueno-center@oriental-gr.com

Name of contact person

1st name
Middle name
Last name	Ryoma Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

03-6801-8480

Homepage URL

Email

r.shimizu@tes-h.co.jp

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name

Organization

Riken Vitamin Co., Ltd.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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

2018

Year

01

Month

28

Day

URL releasing protocol

Publication of results

Published

URL related to results and publications

https://doi.org/10.1016/j.ctim.2018.09.003

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

2016

Year

12

Month

17

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

28

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2017

Year

01

Month

26

Day

Last modified on

2018

Year

09

Month

10

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029714