UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042401 |
|---|---|
| Receipt number | R000048175 |
| Scientific Title | Effects of a Test Food for Body Fat and QOL. |
| Date of disclosure of the study information | 2021/11/09 |
| Last modified on | 2022/01/31 16:10:32 |
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Basic information
Public title
Effects of a Test Food for Body Fat and QOL.
Acronym
Effects of a Test Food for Body Fat and QOL.
Scientific Title
Effects of a Test Food for Body Fat and QOL.
Scientific Title:Acronym
Effects of a Test Food for Body Fat and QOL.
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effects of a Test Food for Body Fat and QOL.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
[1]Indexes for body fat(1) and QOL(2)
(1)Week 0, Week 4, Week 8, Week 12.
(2)Week 0, Week 12.
Key secondary outcomes
*Secondary indexes
[1]Specific blood test(1).
[2]Specific saliva test(1).
[3]Specific fecal test(1).
[4]Specific urinary test(1).
*Safety
[1]Blood pressure, pulsation(2).
[2]Hematologic test(2).
[3]Blood biochemical test(2).
[4]Urine analysis(2).
[5]Bone density measurement(1).
[6]Subject's diary(3).
[7]Doctor's questions(2).
[8]Side effects and adverse events(4).
(1): Week 0, Week 12.
(2): Week 0, Week 4, Week 8, Week 12.
(3): From the first day of ingestion of a test material to the last day of the test.
(4): Week 4, Week 8, Week 12.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of the test meal (3 times in a day; 12 weeks).
Interventions/Control_2
Intake of the test meal (3 times in a day; 12 weeks) and exercise (10 min. in a day; 12 weeks).
Interventions/Control_3
Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a supplement A (3 tablets in a day; 12 weeks).
Interventions/Control_4
Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a supplement B (1 tablet in a day; 12 weeks).
Interventions/Control_5
Intake of the test meal (3 times in a day; 12 weeks) and oral intake of a beverage (1 bottle [600 ml] in a day; 12 weeks).
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1]Healthy Japanese males and females aged 35-65 years.
[2]Individuals whose BMI is more than 23.0 kg 2 and less than 30.0 Kg 2 and visceral fat is high.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can visit an inspection facility and be inspected in designated days.
[5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria
[1]Individuals who cannot continue to eat a test meal for 12 weeks.
[2]Individuals who are in constipation.
[3]Individuals using medical products.
[4]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[5]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[6]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[7]Individuals who contract or have a history of serious endocrine disease.
[8]Individuals who recorded weight gain and loss (+-2 kg) in the past 1 month.
[9]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[10]Individuals who are sensitive to test product or other foods, and medical products.
[11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[13]Individuals who have a habit to use drug claiming to reduce visceral fat and body fat in the past 3 months.
[14]Individuals who are or are possibly, or are lactating.
[15]Individuals who participated in other clinical studies in the past 3 months.
[16]Individuals who are or whose family is engaged in health foods of functional foods.
[17]Individuals judged inappropriate for the study by the principal.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Ono |
Organization
Ueno-Asagao Clinic
Division name
Head
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6240-1162
info@ueno-asagao.clinc
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Shimizu |
Organization
TES Holdings Co., Ltd.
Division name
Administrative Department of Clinical Trials
Zip code
110-0015
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
TEL
+81-3-6801-8480
Homepage URL
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Non-disclosure
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
Ueno-Asagao Clinic Ethical Review Committee
Address
6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN
Tel
+81-3-6240-1162
i.takahashi@tes-h.co.jp
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
| 2021 | Year | 11 | Month | 09 | 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
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
| 2020 | Year | 08 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 26 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In order to prevent the spread of coronavirus(COVID-19) infection, the study was started with a delay of 4 weeks from the scheduled start date, and the intake period of the test food was changed from 12 weeks to 8 weeks.
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048175
