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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | |||
Condition | Healthy adults | ||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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. |
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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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 |
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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |