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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000046642
Receipt No. R000053203
Scientific Title Effects of test food on body composition
Date of disclosure of the study information 2022/01/17
Last modified on 2022/01/14

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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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