UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049522 |
|---|---|
| Receipt number | R000056178 |
| Scientific Title | Validation study on body fat-reducing effects by a long-term test-drink ingestion |
| Date of disclosure of the study information | 2023/11/22 |
| Last modified on | 2023/11/24 13:24:16 |
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Basic information
Public title
Validation study on body fat-reducing effects by a long-term test-drink ingestion
Acronym
Validation study on body fat-reducing effects by a long-term test-drink ingestion
Scientific Title
Validation study on body fat-reducing effects by a long-term test-drink ingestion
Scientific Title:Acronym
Validation study on body fat-reducing effects by a long-term test-drink ingestion
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to verify some kind of body fat-reducing effect by the test-drink intakes for twelve weeks
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visceral fat area (X-ray computerized tomography)
Key secondary outcomes
1. Abdominal total fat area (X-ray computerized tomography)
2. Abdominal subcutaneous fat area (X-ray computerized tomography)
3. Abdominal circumference
4. Body weight, and body-mass index
5. Body fat percentage (impedance method), and body fat quantity (impedance method)
6. Blood pressure, and heart rate
7. Blood-adipocytokine test (adiponectin)
8. Gut microbiota (amplicon sequencing analysis)
9. The Profile of Mood States Second Edition (Japanese short ver.)
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
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of the test drink (2 bottles, 200 mL) after breakfast, once a day.
Interventions/Control_2
Consumption of the placebo drink (2 bottles, 200 mL) after breakfast, once a day.
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
| 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 give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects being under the restriction of meal with dieting (losing some weight by exercises and meal-controlling), and/or are planning to go on a diet.
(2) Subjects taking steadily (over 3 times a week) in the following affecting foods (related to anti-obesity and lipid metabolism); health-specific, functional, supplementary, health foods, vitamin tablet and nutrient.
(3) Subjects who have any difficulty in refraining from taking steadily in affecting medicines (e.g., anti-obesity and lipid metabolism).
(4) Subjects who have taken affecting medicines (antibiotics) within the last month before the test-drink intakes, and planning to take those medicines.
(5) Subjects with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, at the screening test.
(6) Subjects with excessive alcohol intake.
(7) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(8) Pregnant, lactating women, and possibly pregnant ones.
(9) Subjects with drug and/or food allergy.
(10) Subjects being under other clinical tests with some kind of medicine/food, or partook in those within four weeks before this study, or planning to join those after the consent.
(11) Subjects who donated over 0.2 L of their blood and/or blood components within a month to this study.
(12) Males who donated their whole blood (0.4 L) within the last three months to this study.
(13) Females who donated their whole blood (0.4 L) within the last four months to this study.
(14) Males who will be collected in total of their blood (1.2 L) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(15) Females who will be collected in total of their blood (0.8 L) within the last twelve months, after adding the blood amounts planning to be sampled in this study.
(16) Others who have been determined as ineligible for participation, according to the principal/sub investigator's opinions.
Target sample size
80
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
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
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, 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 Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo 103-0021, Japan
Tel
03-6225-9005
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
| 2023 | Year | 11 | 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
| 2022 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 04 | Month | 27 | 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 | 11 | Month | 16 | Day |
Last modified on
| 2023 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056178
