UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051364 |
|---|---|
| Receipt number | R000057790 |
| Scientific Title | Comparative study of lycopene absorption in test food A and test food B |
| Date of disclosure of the study information | 2023/06/19 |
| Last modified on | 2023/12/18 11:48:00 |
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Basic information
Public title
Comparative study of lycopene absorption in test food A and B: A Randomized, Open-label, Parallel Group Comparison Study
Acronym
Comparative study of lycopene absorption in test food A and test food B
Scientific Title
Comparative study of lycopene absorption in test food A and test food B
Scientific Title:Acronym
Comparative study of lycopene absorption in test food A and test food B
Region
| Japan |
Condition
Condition
Healthy asults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare serum lycopene level after 4weeks of ingestion of test food A and B
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum lycopene level at 4 weeks of ingestion
Key secondary outcomes
Serum Triglyceride-rich lipoprotein fraction lycopene level at 2, 4, 6, and 9 hours of ingestion, serum lycopene level at 2 weeks of ingestion
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily ingestion of 40 g of test food A containing lycopene for 4 weeks
Interventions/Control_2
Daily ingestion of 190 g of test food B containing lycopene for 4 weeks
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Adults between 20 and 64 years old
2. Subjects who have been determined to be in good health by a physician's eligibility verification based on the results of a screening test and medical interview.
Key exclusion criteria
1. Subjects who have allergic reaction to test foods.
2. Foods containing ingredients of test food intolerant.
3. Subjects who regularly take foods containing ingredients of test food.
4. Subjects with major surgical history relevant to the digestive system.
5. Subjects who visit the hospital for treatment of illnesses or receiving medication.
6. Pregnant or lactating women, women who expect to be pregnant during this study or may be pregnant.
7. Smokers.
8. Subjects who participate in other clinical trials at time of study entry.
9. Subjects who regularly use medicines, health foods, and supplements.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Takahashi |
Organization
KAGOME CO., LTD.
Division name
Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara-shi, Tochigi
TEL
0287-36-2935
g167_0@kagome.co.jp
Public contact
Name of contact person
| 1st name | Miwa |
| Middle name | |
| Last name | Kaneko |
Organization
SOUKEN CO., LTD
Division name
None
Zip code
105-0013
Address
DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo,
TEL
03-5408-1555
Homepage URL
jimukyoku@mail.souken-r.com
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
KAGOME CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUKEN CO., LTD
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kagome Ethics Committee
Address
Nihonbashi-hamacho F-Tower, 3-21-1 Nihonbashi- hamacho, Chuo-ku, Tokyo
Tel
03-5623-8501
Toshika_Okuni@kagome.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
芝パレスクリニック
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 19 | 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
| 2023 | Year | 02 | Month | 13 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 02 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 06 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057790
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| Registered date | File name |
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