UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046642 |
|---|---|
| Receipt number | R000053203 |
| Scientific Title | Effects of test food on body composition |
| Date of disclosure of the study information | 2022/01/17 |
| Last modified on | 2022/08/03 16:27:05 |
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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
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
r-ito-ih@morinaga.co.jp
Sponsor or person
Institute
3H Medi Solution
Institute
Department
Personal name
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
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
Completed
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 | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053203
