UMIN-CTR Clinical Trial

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
Institute	TES Holdings Co., Ltd.
Institute
Department

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047937