UMIN-CTR Clinical Trial

Basic information
Public title	Study of changes in body composition by ingestion of test food
Acronym	Study of changes in body composition by ingestion of test food
Scientific Title	Study of changes in body composition by ingestion of test food
Scientific Title:Acronym	Study of changes in body composition by ingestion of test food
Region	Japan

Condition
Condition	None
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Effects of food ingredients on body composition
Basic objectives2	Others
Basic objectives -Others	Effects of food ingredients on muscle strength
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	body composition muscle strength
Key secondary outcomes	questionnaire

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	Treatment
Type of intervention	Food
Interventions/Control_1	Ingestion of test food (4weeks).
Interventions/Control_2	Ingestion of placebo food (4weeks).
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	20 years-old <=
Age-upper limit	50 years-old >
Gender	Male and Female
Key inclusion criteria	1) Japanese individuals aged 20-50 years,who have recently lacked physical strength due to lack of exercise. 2) Individuals who can exercise regularly (at least 2-3 times a week) during the test period 3) Individuals who have not taken protein products intended to build muscle 4) Individuals who are healthy and are not suffered from a chronic malady. 5) Individuals whose written informed consent has been obtained. 6) Individuals who can visit an inspection facility and be inspected in designated days. 7) Individuals judged appropriate for the study by the principal.
Key exclusion criteria	1)Individuals using medical products. 2)Individuals who have a history of serious hepatopathy, kidney damage, heart disease, lung and blood disease. 3)Individuals who contract or have a history of serious gastrointestinal disease. 4)Individuals who have an addiction to alcohol or a mental illness. 5)Individuals who used or applied a drug for treatment of disease in the past 1 month. 6)Individuals with probable seasonal allergy, such as pollinosis, during the test period.(In particular, Betulaceae: alder, oba alnus firma, shirakaba, Taxodiaceae: cryptomeria, hinoki cypress, Asteraceae: ragweed, Artemisia vulgaris indica, Gramineae:Dactylis glomerata, Phleum pratense) 7)Individuals who have possibility of allergy symptoms onset by the test food and who cause severe allergic symptoms in foods and medicines. 8)Individuals cannnot drink milk or dairy products. 9)Individuals with serious anemia. 10)Individuals with high blood glucose(fasting blood glucose over 126mg/dL). 11)Individuals who are a smoker. 12)Females who are or are possibly pregnant, or are lactating. 13)Individuals whose life style will change during the test period. 14)Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. 15)Individuals who were hospitalized and received treatment in the past 6 months. 16)Individuals who participated in other clinical studies in the past 1 months or will participate in other clinical studies during the test period. 17)Individuals judged inappropriate for the study by the principal.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Hiroko Middle name Last name Uchida
Organization	MORINAGA & CO., LTD.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Email	h-uchida-ji@morinaga.co.jp

Public contact
Name of contact person	1st name Takayuki Middle name Last name Yamamoto
Organization	MORINAGA & CO., LTD.
Division name	Health Science and Research Center, R&D institute
Zip code	230-8504
Address	2-1-1, Shimodueyoshi, Tsurumi-ku, Yokohama
TEL	045-571-6140
Homepage URL
Email	t-yamamoto-jc@morinaga.co.jp

Sponsor
Institute	MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization	MORINAGA & 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	Japan Conference of Clinical Research
Address	1-13-23 Minamiikebukuro, Toshima-ku, Tokyo
Tel	03-6868-7022
Email	None

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 09 Month 30 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled	40
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	Main results already published
Date of protocol fixation	2020 Year 06 Month 03 Day
Date of IRB	2020 Year 06 Month 18 Day
Anticipated trial start date	2020 Year 06 Month 19 Day
Last follow-up date	2020 Year 08 Month 06 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 07 Month 02 Day
Last modified on	2021 Year 01 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046792