UMIN-CTR Clinical Trial

Basic information
Public title	Effects of test food on body composition
Acronym	Effects of test food on body composition
Scientific Title	Effects of test food on body composition
Scientific Title:Acronym	Effects of test food on body composition
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to examine effects of test food on body composition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Body composition (Analysis by InBody; weight, body water content, skeletal muscle mass (segmental analysis), total protein mass, total mineral content, bone mineral content, body fat mass (segmental analysis), body fat percentage, basal metabolic rate, visceral fat level, SMI, BMI, impedance(segmental analysis))
Key secondary outcomes	Various questionnaires

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Oral ingestion of the test food for four weeks
Interventions/Control_2	Oral ingestion of the placebo food for four weeks
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	1) Individuals aged 20-59 years. 2) Individuals whose BMIs are >=18.5 and <30. 3) Individuals who can exercise more than twice a week during this test period. 4) Individuals who do not take any protein-fortified product for this test period. 5) Individuals who are healthy and do not have chronic disease. 6) Individuals who are fully informed about this study, have the ability to agree, participate voluntarily with good understanding, and agree informed consent in writing. 7) Individuals who can visit an inspection facility and be inspected in designated days. 8) Individuals who do not get vaccinated against COVID-19 for this test period. 9) Individuals judged appropriate for this study by the principal investigator.
Key exclusion criteria	1) Individuals who have some chronic disease, and under medical treatment. 2) Individuals who have or had a history of sever diseases such as hepatopathy, kidney damage, heart disease, lung, and blood disease. 3) Individuals who have or had a history of severe gastrointestine disease (who can participate it if the principal investigator permit). 4) Individuals who are heavy drinker of alcohol or have some mental disorder. 5) Individuals who are under medications medical treatment in the past 1 month (excluding medications to be taken only once, such as headache medicine, menstrual pain medicine, common cold medicine, etc.). 6) Individuals who will develop seasonal allergic such as to pollen for test period. Examples of pollen include birch family, cedar family, asteraceae family, and poaceae family. 7) Individuals who have allergic to certain foods (including a history of allergies). 8) Individuals who are lactose intolerant or do not like milk and dairy products. 9) Individuals who are currently treating anemia. 10) Individuals whose fasting blood glucose level is in the diabetic range (more than 126mg/dL). 11) Individuals who are a smoker. 12) Females who are planning to get pregnant or are currently pregnant and lactating. 13) Individuals who have or will possibly have irregular life rhythms for this test period (due to late night overtime work, long business trips, etc.). 14) Individuals who take food for specified health use or foods with functional or supplements including this functional ingredients now or in the past 1 month, or are planning to take them for this test period. 15) Individuals who were hospitalized in the past 6 months, or are planning to be hospitalized for this test period. 16) Individuals who are currently participating in other clinical trials, or have not passed 1 month after participating, in other clinival traials. 17) Individuals judged inappropriate for this study by the principal investigator.
Target sample size	100

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 Ryouichi Middle name Last name Ito
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	r-ito-ih@morinaga.co.jp

Sponsor
Institute	3H Medi Solution
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	Institutional Review Board of Non-profit organization Tokyo Allergy and Respiratory Disease Research Institute
Address	4F Sanwauchikanda Building, 3-3-5 Uchikanda, Chiyoda-ku, Tokyo
Tel	080-7360-0910
Email	info@inclusion-p.com

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	医療法人社団知正会 東京センタークリニック

Other administrative information
Date of disclosure of the study information	2022 Year 01 Month 17 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	100
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	No longer recruiting
Date of protocol fixation	2021 Year 11 Month 04 Day
Date of IRB	2021 Year 11 Month 18 Day
Anticipated trial start date	2021 Year 12 Month 10 Day
Last follow-up date	2022 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 01 Month 14 Day
Last modified on	2022 Year 01 Month 14 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053203

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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