UMIN-CTR Clinical Trial

Basic information
Public title	Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Acronym	Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Scientific Title	Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Scientific Title:Acronym	Effect test of continuous intake of test food for 8 weeks on endurance and fatigue in healthy adult women
Region	Japan

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

Objectives
Narrative objectives1	The purpose of this study is to examine the effects on endurance and fatigue of Japanese women aged between 40 and 70 years old by taking test foods continuously for 8 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1)Primary efficacy assessment VAS questionnaire
Key secondary outcomes	2)Secondary evaluation of effectiveness POMS2 shortened version,body composition,shuttle stamina walk test 3)Safety evaluation Vital signs,biochemical tests, hematological tests,adverse events

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are 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	8-week intake of the test food
Interventions/Control_2	8-week intake of the 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	40 years-old <=
Age-upper limit	70 years-old >
Gender	Female
Key inclusion criteria	1.Healthy Japanese female aged 40 years or older and younger than 70 years at the time of the informed consent. 2.Subject who feels tired on a daily basis. 3.Subject who usually takes three meals a day. 4.Subject who has understood the purpose of the study, and agreed to participate it by signing the written informed consent.
Key exclusion criteria	1.Heavy drinker 2.Subject who has strong exercise habits. 3.Subject who has experienced chest pain or abnormal pulse at rest. 4.Subject who frequently has palpitations, shortness of breath, lightheadedness, dizziness or loss of consciousness. 5.A family member who has died suddenly for unknown reasons. 6.Subject who has been diagnosed as having problems with the legs. 7.Subject who is receiving the rheumatism treatment. 8.Subject with a history of knee surgery or disease, or who regularly use of cane. 9.Subject with severe hay fever symptoms affecting fatigue. 10.Subject whose protein intake is restricted by a doctor (including mild restrictions). 11.Subject who is taking medication or under medical treatment because of some serious disease. 12.Subject who is under exercise therapy or dietetic therapy. 13.Subject who has an allergy for test food(27 items: milk, soy). 14.Subject who has or had a history of either medicine or alcohol dependence syndrome. 15.Subject who has or had a history of mental illness (depression) or sleep disturbance.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Email	ochitani@huma-rd.co.jp

Public contact
Name of contact person	1st name Daisuke Middle name Last name Ochitani
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Zip code	108-0014
Address	Round Cross Tamachi 10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	03-3431-1260
Homepage URL
Email	ochitani@huma-rd.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	CHARLE CO.,LTD.
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	Ethics Committees of Nihonbashi Egawa Clinic
Address	2F Kotobuki Build. 1-1-3 Yaesu Chuo-ku, Tokyo 103-0028 Japan
Tel	03-5204-0311
Email	jim@medipharma.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 03 Month 05 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
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 02 Month 07 Day
Date of IRB	2020 Year 02 Month 14 Day
Anticipated trial start date	2020 Year 02 Month 26 Day
Last follow-up date	2020 Year 05 Month 01 Day
Date of closure to data entry	2020 Year 05 Month 07 Day
Date trial data considered complete	2020 Year 05 Month 21 Day
Date analysis concluded	2020 Year 07 Month 27 Day

Other

Other related information

(Exclusion criteria continued) 16.Subject who has irregular work rhythms such as working at night and shift work. 17.Subject who has extremely irregular lifestyle such as eating and sleeping. 18.Subject who has an unbalanced diet. 19.Subject who has or had a history of severe diseases such as brain disease, malignant tumor, immune disease, diabetes, liver disease (hepatitis), kidney disease, heart disease, thyroid disease, adrenal disease, other metabolic diseases. 20.Subject who uses health foods, supplements, and pharmaceuticals that affect protein metabolism (including protein) or reduce fatigue. 21.Subject who has participated in other clinical studies within the past 3 months from the day of the consent acquisition or who is planning to participate in other clinical studies during the current study. 22.Subject who has blood drawn or blood component more than 200mL within the past 1 months or more than 400mL within the past 3 months from the day of the consent acquisition. 23.Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 24.Subject who can't keep the daily records. 25.Subject who is judged as an inappropriate candidate according to the screening data. 26.Subject who is considered as an inappropriate candidate by the doctor in charge.

Management information
Registered date	2020 Year 02 Month 25 Day
Last modified on	2020 Year 07 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045107