UMIN-CTR Clinical Trial

Public title

Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.

Acronym

Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.

Scientific Title

Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.

Scientific Title:Acronym

Randomized, double-blind, crossover, confirmation test of cold sensitivity and blood flow improving function by ingesting test food.

Region

Japan

Condition

Females in good health

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To confirm improving function of cold sensitivity and blood flow of test food.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Body surface temperature and blood flow after 2 weeks ingestion of test food.

Key secondary outcomes

Blood NOx concentration on 60min after test food ingestion.
Questionnaire after 2 weeks ingestion of test food.

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

Prevention

Type of intervention

Food

Interventions/Control_1

Ingesting test food, 2 tablets after completion of morning meal for 2 weeks. After 2 weeks of washout period, ingesting placebo food, 2 tablets in a day for 2 weeks.

Interventions/Control_2

Ingesting test food, 2 tablets after completion of morning meal for 2 weeks. After 2 weeks of washout period, ingesting test food, 2 tablets in a day for 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

20

years-old

<=

Age-upper limit

Not applicable

Gender

Female

Key inclusion criteria

1) Females aged over 20 years old when obtaining informed consent.
2) Subjects who have subjective symptoms of cold sensitivity.
3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.

Key exclusion criteria

1) Subjects who were diagnosed as chilliness by medical doctor.
2) Subjects who ingest medicines and/or supplement regularly for improving fatigue, blood flow, cold sensitivity or stress.
3) Pregnant or possibly pregnant women, or lactating women.
4) Subjects who have previous and/or current medical history of serious disease in heart, liver, kidney and/or digestive trucks.
5) Subjects who excessive alcohol intake.
6) Subjects who have extremely irregular life rhythms, and subjects who have midnight work or irregular shift work.
7) Subjects who have previous medical history of drug and/or food allergy.
8) Subjects who are participating the other clinical tests of medicines or foods. Subjects who participated other clinical tests of medicines or foods within 4-weeks prior to the current study.
9) Subjects who donated over 200mL blood and/or blood components within a month to the current study.
10) Subjects who donated over 400mL blood within the last four months to the current study.
11) Subjects who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
12) Subjects who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

25

Name of lead principal investigator

1st name	Katsuhisa
Middle name
Last name	Sakano

Organization

CPCC Company Limited

Division name

Clinical Research Planning Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC Company Limited

Division name

Plan Sales Department

Zip code

101-0047

Address

4F Chushin Build. 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047 Japan

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

TAIHO PHARMACEUTICAL CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan

Tel

03-5297-5548

Email

IRB@cpcc.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

2017

Year

01

Month

23

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

20

Day

Date of IRB

Anticipated trial start date

2017

Year

01

Month

24

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

23

Day

Last modified on

2020

Year

10

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029669