UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Title of the study (Brief title)	A study to evaluate the effect of intake of the supplement on the blood flow, fatigue in women
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effects of the ingestion of a single intake and 4 consecutive weeks of active test food on the blood flow, fatigue
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Blood flow
Key secondary outcomes	Skin surface temperature, POMS2, skin questionnaire

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of a single intake and 4 consecutive weeks of active test food
Interventions/Control_2	Ingestion of a single intake and 4 consecutive weeks of placebo food
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	49 years-old >=
Gender	Female
Key inclusion criteria	(1) Female workers from 30 to 49 years old (2) Clerical workers (3) Subjects who are feeling fatigue because of work
Key exclusion criteria	(1) Subjects who routinely use food or medicine containing of functional substance (2) Subjects who performs an act for the improvement of the blood flow, the fatigue, stress, and the quality of the sleep (3) Subjects who use the warm cream (4) Night and day shift worker or manual laborer (5) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor (6) Subjects who has under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome (7) Subjects who has had a diagnosis of chronic fatigue syndrome (8) Subjects who has under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion (9) Smokers (10) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnair (11) Subjects having possibilities for emerging allergy related to the study (12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (13) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study (14) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating (15) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	20

Research contact person
Name of lead principal investigator	Jiro Saito
Organization	Medical Station Clinic
Division name	None
Address	3-12-8 Takabann, Meguro-ku, Tokyo, Japan
TEL	03-6452-2712
Email	info@med-station.jp

Public contact
Name of contact person	Takashi Nakagawa
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	Seibu Shinkin Bank Ebisu Bldg., 1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	t.nakagawa@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	Unitec Foods Co, Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 05 Month 26 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 05 Month 24 Day
Anticipated trial start date	2018 Year 05 Month 27 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2018 Year 05 Month 26 Day
Last modified on	2018 Year 11 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037327