UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044908 |
|---|---|
| Receipt number | R000051225 |
| Scientific Title | Validation study about test food-ingesting effects on visceral fat area and gut microenvironment |
| Date of disclosure of the study information | 2022/07/22 |
| Last modified on | 2022/07/28 15:18:04 |
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Basic information
Public title
Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Acronym
Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Scientific Title
Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Scientific Title:Acronym
Validation study about test food-ingesting effects on visceral fat area and gut microenvironment
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To validate some kind of effect by the test-food intakes for twelve weeks on visceral fat area and gut microenvironment
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area (impedance method)
Key secondary outcomes
1. Abdominal total fat area (impedance method)
2. Abdominal subcutaneous fat area (impedance method)
3. Abdominal circumference
4. Body weight
5. Body-mass index
6. Body fat percentage (impedance method)
7. Body fat quantity (impedance method)
8. Blood pressure
9. Adiponectin
10. Gut microbiota (amplicon sequencing analysis)
11. Short chain fatty acids and IgA in feces
12. Total cholesterol, low density lipoprotein-cholesterol, high density lipoprotein-cholesterol, glucose
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test food-1 twice a day for 12 weeks.
Interventions/Control_2
Consumption of the test food-2 twice a day for 12 weeks.
Interventions/Control_3
Consumption of the placebo food twice a day for 12 weeks.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Healthy male/female subjects ranging in age from 20 to 64, at informed consent.
(2) Subjects ranging in BMI from not less than 23.0 to less than 30.0 kg/m2.
(3) Subjects who can take the test foods for meals twice a day.
(4) Subjects who can receive the test foods twice a week.
(5) Subjects who can give informed consent to participate in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
Subjects - -
(1) with dieting (exercise, meal-control), or going on,
(2) taking in affecting foods (obesity/gut/ immuno-regulation, not less than 3 times a week,
(3) with excessive alcohol intake,
(4) who have taken affecting medicines (allergic/gut/laxative/obesity/antibiotic regulation) within the last month before the test-food intakes,
(5) with history of appendix removal,
(6) who have received affecting surgeries (colonoscopy, gallstones/gall bladder removal, gastric bypass) within half a year before the consent,
(7) planning to change their present life style and dietary habit,
(8) with extremely irregular dietary habit,
(9) with the roomer planning to participate in this study,
(10) restricting their mealtimes to no more than once a day (not less than once a week), within the last month,
(11) with medical history of serious diseases,
(12) with a continuous medical treatment,
(13) with not less than 6.5 % HbA1c,
(14) with not less than 126 mg/dL of hungry blood-sugar level,
(15) with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area,
(16) with pregnancy, possibly one, or lactating,
(17) with drug/food allergy (wheat, egg, milk),
(18) being under the other clinical tests (medicine or health food), or took part in those within the last 4 weeks, or will join those after the consent,
(19) who donated their blood components or blood (0.2 L) within the last month,
(20) who donated his blood (0.4 L) within the last 3 months,
(21) who donated her blood (0.4 L) within the last 4 months,
(22) being collected in total of his blood (1.2 L) within the last 12 months and in this study,
(23) being collected in total of her blood (0.8 L) within the last 12 months and in this study,
(24) being determined as ineligible by the principal/sub investigator - - .
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Nisshin Seifun Group Inc.
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 Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2022 | Year | 07 | Month | 22 | 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
| 2021 | Year | 07 | Month | 16 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 09 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 22 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 19 | Day |
Last modified on
| 2022 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051225
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