UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042012
Receipt number R000047937
Scientific Title Examination of the Effects of a Functional Food on Blood Flow and Cold Sensitivity: An Open Trial.
Date of disclosure of the study information 2020/10/07
Last modified on 2021/04/05 22:41:46

* 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

Examination of the Effects of a Functional Food on Blood Flow and Cold Sensitivity: An Open Trial.

Acronym

Examination of the Effects of a Functional Food on Blood Flow and Cold Sensitivity: An Open Trial.

Scientific Title

Examination of the Effects of a Functional Food on Blood Flow and Cold Sensitivity: An Open Trial.

Scientific Title:Acronym

Examination of the Effects of a Functional Food on Blood Flow and Cold Sensitivity: An Open Trial.

Region

Japan


Condition

Condition

N/A (healthy adults)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to examine of the effects of a functional food on blood flow and cold sensitivity.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Indexes for effectiveness (blood flow measurement with laser doppler(1), skin surface temperature measurement with thermography(1), image instrumentation of capillary vessel(2), Subjective questionnaire(1).
(1)Screening, Week 4: before the cold stress test, just after the cold stress test, 2 min. after the cold stress test, 4 min. after the cold stress test, 6 min. after the cold stress test, 8 min. after the cold stress test, 10 min. after the cold stress test.
(2)Screening, Week 4: before the cold stress test.

Key secondary outcomes

*Safety indexes
[1]Blood pressure, pulsation(1)
[2]Weight, body fat percentage, BMI(1)
[3]Axillary temperature(1)
[4]Hematologic test(1)
[5]Blood biochemical test(1)
[6]Urine analysis(1)
[7]Doctor's questions(1)
[8]Side effects and adverse events(2)
[9]Subject's diary(3)
(1)Screening, Week 4: before the cold stress test.
(2)Week 4: before the cold stress test.
(3)each day from Screening and one day before the Week 4.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

[1]A cold stress test.
[2]Measurement.
[3]Oral intake of the test food (3 capsules in a day; 4 weeks).
[4]A cold stress test.
[5]Measurement.

Interventions/Control_2


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

30 years-old <=

Age-upper limit

50 years-old >

Gender

Female

Key inclusion criteria

[1]Healthy Japanese females aged 30-49 years.
[2]Individuals who are healthy and have no chronic physical disease.
[3]Individuals who are aware of being sensitive to cold.
[4]Individuals whose written informed consent has been obtained.
[5]Individuals who can have an examination on a designated check day.
[6]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals using medical products.
[2]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia. Individuals who use a drug for treatment of disease.
[3]Individuals who use a drug to treat a disease in the past 1 month.
[4]Individuals who have a history of serious hepatopathy, kidney damage, heart disease and hematological disease.
[5]Individuals who are a patient or have a history of or endocrine disease.
[6]Individuals whose menstruation is irregular (individuals whose menstruation cycle must be 28 +- 2 days).
[7]Individuals whose BMI is less than 18.5kg/m2 or over 25kg/m2.
[8]Individuals with serious anemia.
[9]Individuals who are a smoker.
[10]Individuals with inflammation and scratch at fingers.
[11]Individuals who have excessive alcohol intake more than 60 g in a day of pure alcohol equivalent.
[12]Individuals who have allergic reaction to ingredients of test foods and other foods or drugs.
[13]Individuals with possible changes of life style during the test period.
[14]Individuals who have a habit to use Foods with Function Claims, functional foods and/or supplements claiming to improve cold sensitivity, blood flow, blood pressure, and thermal comfort effect in the past 3 months and/or are planning to use those foods during test periods.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who participated in other clinical studies in the past 3 months.
[17]Individuals who are or whose family is an employee of a health food, functional food, or cosmetic company.
[18]Individuals judged inappropriate for the trial by the principal.

Target sample size

24


Research contact person

Name of lead principal investigator

1st name Takahiro
Middle name
Last name Ono

Organization

Ueno-Asagao Clinic

Division name

Head

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6240-1162

Email

info@ueno-asagao.clinc


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd.

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd.

Institute

Department

Personal name



Funding Source

Organization

Cloud 9 Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ueno-Asagao Clinic Ethical Review Committee

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

Tel

+81-3-6240-1162

Email

i.takahashi@tes-h.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

2020 Year 10 Month 07 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

23

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

2020 Year 09 Month 16 Day

Date of IRB

2020 Year 09 Month 16 Day

Anticipated trial start date

2020 Year 10 Month 08 Day

Last follow-up date

2020 Year 11 Month 05 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 10 Month 05 Day

Last modified on

2021 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047937