UMIN-CTR Clinical Trial

Basic information
Public title	Investigation of the effects of continuous intake of test foods on muscles
Acronym	Investigation of the effects of continuous intake of test foods on muscles
Scientific Title	Investigation of the effects of continuous intake of test foods on muscles
Scientific Title:Acronym	Investigation of the effects of continuous intake of test foods on muscles
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 investigate the effect of continuous intake of test foods for 12 weeks on muscles in healthy Japanese men and women aged 45 to 65 years.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition (skeletal muscle mass, basal metabolic rate, protein mass, body fat mass, body weight, BMI, muscle mass, body fat percentage, upper limb muscle mass, trunk muscle mass, leg muscle mass, body water content)
Key secondary outcomes	Special blood test (TNF-alpha, IL-6), Chalder Fatigue Scale, VAS questionnaire, subjective symptom questionnaire, motor ability test (lower limb muscle strength, grip strength, eye-opening one-leg standing test, 6-minute walk test, 6-m walk test, 2 steps test, 10 times chair stand-up test)

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	Prevention
Type of intervention	Food
Interventions/Control_1	Test foods consumption for 12 weeks.
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	45 years-old <=
Age-upper limit	65 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Japanese men and women aged 45 to 65 years old at the time of informed consent. 2)Subject who is worried about muscle weakness. 3)Subject who can measure physical fitness. 4)Subject who has received sufficient explanation of the purpose and content of the research, has the ability to consent, voluntarily volunteered to participate in the examination after understanding it well, and agreed to participate in the examination in writing. 5)Subject who can continuously take the test food for 12 weeks during the test period. 6)Subject who is judged not to be sick by the interview with the investigator.
Key exclusion criteria	1)Subject who is currently undergoing medication or outpatient treatment due to some serious illness or knee or low back pain. 2) Heavy drinkers. 3)Subject who has suffered severe damage to the locomotorium such as fractures, tendon ruptures, and pulled muscle in the last year. 4)Subject who has experienced strong chest pain or abnormal pulse at rest. 5)Subject who uses a pacemaker or artificial joints. 6)Subject who frequently has palpitation, shortness of breath, lightheadedness, dizziness or loss of consciousness. 7)Subject diagnosed with leg and waist disorders. 8)Subject who has a history of knee surgery, has a disease, or uses a cane on a daily basis. 9)Subject who has high-intensity exercise habits. 10)Subject who is under exercise therapy or diet therapy. 11)Subject who has an allergy for test food. 12)Subject who has or had a history of either medicine or alcohol dependence syndrome. 13)Subject who has or had a history of mental illness (ex. depression) or sleep disturbance. 14)Subject who has irregular work rhythms such as working at night and shift work. 15)Subject who has extremely irregular lifestyle such as eating and sleeping.
Target sample size	10

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	non-disclosure
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 Yoga Allergy Clinic
Address	4-32-16 Yoga,Setagaya-ku,Tokyo 158-0097 Japan
Tel	03-5491-4478
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 12 Month 18 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	10
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 11 Month 04 Day
Date of IRB	2020 Year 11 Month 13 Day
Anticipated trial start date	2020 Year 12 Month 21 Day
Last follow-up date	2021 Year 04 Month 27 Day
Date of closure to data entry	2021 Year 05 Month 14 Day
Date trial data considered complete	2021 Year 05 Month 21 Day
Date analysis concluded	2021 Year 06 Month 08 Day

Other

Other related information

(Exclusion criteria continued) 16)Subject who has an unbalanced diet. 17)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. 18)Subject who uses health foods, supplements, and medicines that affect muscles. 19)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. 20)Subject who has blood drawn or blood component more than 200mL within the past 1 month or more than 400mL within the past 3 months from the day of the consent acquisition. 21)Subject who is planning to get pregnant after the day of informed consent or is currently pregnant and lactating. 22)Subject who can't keep the daily records. 23)Subject who is judged as an inappropriate candidate according to the screening data. 24)Subject who is considered as an inappropriate candidate by the investigator.

Management information
Registered date	2020 Year 12 Month 18 Day
Last modified on	2021 Year 07 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048820