UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048886 |
|---|---|
| Receipt number | R000055565 |
| Scientific Title | Examination of lipid metabolism-improving effects by taking a single dose of test beverage |
| Date of disclosure of the study information | 2023/09/12 |
| Last modified on | 2023/09/15 20:51:41 |
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Basic information
Public title
Examination of lipid metabolism-improving effects by taking a single dose of test beverage
Acronym
Examination of lipid metabolism-improving effects by taking a single dose of test beverage
Scientific Title
Examination of lipid metabolism-improving effects by taking a single dose of test beverage
Scientific Title:Acronym
Examination of lipid metabolism-improving effects by taking a single dose of test beverage
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigating some kind of improvement effect in lipid metabolism by ingesting a specified single dose of the test beverage to the subjects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory quotient, and fat oxidation amount
Key secondary outcomes
1. Energy expenditure level
2. Total-Cholesterol
3. Triglyceride
4. High Density Lipoprotein-Cholesterol
5. Low Density Lipoprotein-Cholesterol
6. Non-Esterified Fatty Acid
7. Salivary cortisol
8. Back surface temperature
9. Visual Analogue Scale (fatigue feeling)
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Ingestion of the test beverage (200 mL) to the subject before starting the measurement of respiratory metabolism.
Interventions/Control_2
Ingestion of the placebo beverage (200 mL) to the subject before starting the measurement of respiratory metabolism.
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 who do not have a habit of exercises.
(3) Subjects ranging in BMI from 23.0 to less than 30.0 kg/m2.
(4) Subjects who can give the consent to partake in this trial after being provided with an explanation of the protocol detail.
Key exclusion criteria
(1) Subjects taking steadily (not less than 3 times a week) in the following affecting foods; health-specific, functional, health foods (related to blood pressure, blood stream, exercise fatigue, metabolism-improving, poor blood flow-improving, fat combustion and/or lipolysis), supplementary one, vitamin tablet and nutrient, with any difficulty in refraining from having those after the consent.
(2) Subjects who have any difficulty in refraining from taking steadily (not less than 3 times a week) in affecting medicines (e.g., lipid metabolism), during this trial.
(3) Subjects with any possibility of hindrance to this trial, owing to their allergic rhinitis.
(4) Subjects with not less than 25.0 kg/m2 of BMI and not less than 100 cm2 of abdominal fat area, at the consent.
(5) Subjects who take excessive alcohol.
(6) Subjects having a habit of smoking.
(7) Subjects who are now under other clinical tests, or partook in those within 4 weeks before this trial.
(8) Subjects with current and/or previous medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(9) Pregnant, possibly pregnant, or lactating women.
(10) Subjects suffering from severe anemia.
(11) Subjects having drug and/or food allergy.
(12) Subjects who donated over 0.2 L of their whole blood and/or blood components within a month before this trial.
(13) Males who donated their whole blood (0.4 L) within the last 3 months to this trial.
(14) Females who donated their whole blood (0.4 L) within the last 4 months to this trial.
(15) Males who will be collected in total of their blood (1.2 L) within the last 12 months, after adding the blood amounts planning to be sampled in this trial.
(16) Females who will be collected in total of their blood (0.8 L) within the last 12 months, after adding the blood amounts planning to be sampled in this trial.
(17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size
40
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 | 09 | Month | 12 | 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 | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 12 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 28 | 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 | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055565
