UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020151 |
|---|---|
| Receipt number | R000023275 |
| Scientific Title | Effect of a plant-derived ingredient containing food on lipid metabolism. |
| Date of disclosure of the study information | 2015/12/18 |
| Last modified on | 2019/01/31 16:19:38 |
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Basic information
Public title
Effect of a plant-derived ingredient
containing food on lipid metabolism.
Acronym
Efflcacy of a plant-derived ingredient
containing food for postprandial
lipid metabolism.
Scientific Title
Effect of a plant-derived ingredient
containing food on lipid metabolism.
Scientific Title:Acronym
Efflcacy of a plant-derived ingredient
containing food for postprandial
lipid metabolism.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of single
ingestion of a plant-derived
ingredient containing a food on
postprandial lipid metabolism in
healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
8 hours of postprandial fat oxidation measurement by human calorimeter.
Key secondary outcomes
8 hours of postprandial energy expenditure and respiratory quotient measurement by human calorimeter.
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single ingestion of plant-derived ingredient containing food (test food code: A001)->washout->Single ingestion of plant-derived ingredient not containing food (control food code: P001).
Interventions/Control_2
Single ingestion of plant-derived ingredient not containing food (control food code: P001))->washout->Single ingestion of plant-derived ingredient containing food (test food code: A001).
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
| 24 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy males and females.
Key exclusion criteria
1. difficult to participate the study due to dysfunctions liver, or the other dysfunctions.
2. experienced a seizures based on circulatory-diseases before, or is under treatment.
3. arrhythmic.
4. who takes medication for glucose or fat metabolism, or hypertention.
5. who have experienced a seizures based on neural disease.
6. who was given surgery for a disease or an injury 2 months prior to the study.
7. who was given gastrectomy and/or bypass of part of the intestine.
8. who have allergic reaction for food.
9. Individual experienced unpleasant feeling during blood drawing.
10. claustrophobia.
11. insomnia.
12. chronic headache (migraine, tension headache, cluster headache, etc. ).
13. Person who donated more than 200mL of blood within a month, or more than 400mL within three months prior to informed consent.
14. who sleep habitually after 1:00 a.m. on weekday.
15. Heavy smoker
16. who had a weight change of more than +-2.0 kg for one month prior to informed consent.
17. who is engaged in night work and shift operations for more than 3 months prior to informed consent.
18. who is pregnant or expecting pregnancy.
19. who habitually take the foods for specified health uses (FOSHU) or functional food which solicits body fat reduction and absorption suppression of lipid or the carbohydrates (except for person who can stop consume them after informed consent.).
20. who can't accept doctor to check health condition, accessing the health examination result for the past two years, prior to the study.
21. who can't disclose age, the latest health examination result.
22. who can't reply to the questionnaire about living situation and condition.
23. who cannot indicate a menstruation situation.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Noriko Osaki |
Organization
Kao Corporation
Division name
R&D-Development Research-Healthcare Food Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 1318501, JAPAN
TEL
03-5630-7224
osaki.noriko@kao.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshitaka Sakuda |
Organization
Kao Corporation
Division name
R&D-Development Research-Healthcare Food Research
Zip code
Address
2-1-3, Bunka, Sumida-ku, Tokyo, 1318501, JAPAN
TEL
03-5630-7456
Homepage URL
sakuda.toshitaka@kao.co.jp
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
花王株式会社ヘルスケア食品研究所（東京都）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 18 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 10 | Day |
Last modified on
| 2019 | 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=R000023275
