UMIN-CTR Clinical Trial

Public title

Examination of the Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress: Placebo controlled, Randomized, Double-blind, Cross-over Study

Acronym

Examination of the Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress: Placebo controlled, Randomized, Double-blind, Cross-over Study

Scientific Title

Examination of the Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress: Placebo controlled, Randomized, Double-blind, Cross-over Study

Scientific Title:Acronym

Examination of the Effects of Long Pepper Extract on Blood Flow and Skin Surface Temperature Following the Exposure to Cold Water Stress: Placebo controlled, Randomized, Double-blind, Cross-over Study

Region

Japan

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study examines the effects of long pepper extract on blood flow and skin surface temperature following the exposure to cold water stress.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

[1]Blood flow measurement with laser doppler (First observation, Second observation)
[2]Skin surface temperature measurement with thermography (Screening, First observation, Second observation)

Key secondary outcomes

*Secondary outcomes
[1]Axillary temperature (Screening, First observation, Second observation)
[2]Doctor's questions (Screening, First observation, Second observation)
[3]Subject's diary(From the first day of ingestion of a test material to the last day of the test)

*Other indexes
[1]Height, weight, body fat percentage, BMI (Screening)
[2]Blood pressure (Screening)
[3]Subjective questionnaire on cold (Screening)
[4]Simplified Menopausal Index (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

[1]Oral intake of the test product (containing long pepper extract; 1 package in a day; 1 time)
[2]The exposure to cold water stress
[3]Observation
[4]Washout (1 week)
[5]Oral intake of the placebo product (not containing long pepper extract; 1 package in a day; 1 time)
[6]The exposure to cold water stress
[7]Observation

Interventions/Control_2

[1]Oral intake of the placebo product (not containing long pepper extract; 1 package in a day; 1 time)
[2]The exposure to cold water stress
[3]Observation
[4]Washout (1 week)
[5]Oral intake of the test product (containing long pepper extract; 1 package in a day; 1 time)
[6]The exposure to cold water stress
[7]Observation

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

65

years-old

>

Gender

Female

Key inclusion criteria

[1]Japanese females aged 20-64 years.
[2]Individuals who are healthy.
[3]Individuals who are sensitive to cold.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who used a drug to treat a disease in the past 1 month (except temporal usage for pollenosis).
[3]Individuals who use a drug to treat a disease.
[4]Individuals who were an asthmatic patient in the past 3 months or is an asthmatic patient.
[5]Individuals with serious anemia.
[6]Individuals who are sensitive to a test product or other foods, and medical products.
[7]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period.
[8]Individuals with serious diseases (ex. diabetes, hepatopathy disease, kidney damage, heat failure, endocrine disease), or who are a patient of or have a history of thyroid disease, adrenal disease, metabolic disease).
[9]Individuals who conducted hormone replacement therapy in the past 3 months or have a history of conducting hormone replacement therapy.
[10]Individuals who have an inflammation or a scar on a measuring area.
[11]Individuals whose systolic blood pressure is over 160mmHg or diastolic pressure is over 100mmHg.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[14]Individuals who are a smoker.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals whose Simplified Menopausal Index score is over 51.
[17]Individuals who have a history of ovarian resection or hysterectomy.
[18]Individuals who are or are possibly, or are lactating.
[19]Individuals judged inappropriate for the study by the principal.

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Shuji Nakata

Organization

Medical Corporation Bokushinkai CLINTEXE Clinic

Division name

Director

Zip code

Address

4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN

TEL

03-5405-1059

Email

info@tes-h.co.jp

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

Maruzen Pharmaceuticals 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

2017

Year

01

Month

31

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

2017

Year

01

Month

16

Day

Date of IRB

Anticipated trial start date

2017

Year

02

Month

09

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

29

Day

Last modified on

2017

Year

03

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029728