UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048976 |
|---|---|
| Receipt number | R000055799 |
| Scientific Title | Evaluation of the effects of combined consumption of test foods containing plant-derived bioactive substances on the biomarker in blood |
| Date of disclosure of the study information | 2022/09/21 |
| Last modified on | 2023/12/20 10:00:16 |
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Basic information
Public title
Evaluation of the effects of combined consumption of test foods containing plant-derived bioactive substances on the biomarker in blood
Acronym
Evaluation of the effects of combined consumption of test foods containing plant-derived bioactive substances on the biomarker in blood
Scientific Title
Evaluation of the effects of combined consumption of test foods containing plant-derived bioactive substances on the biomarker in blood
Scientific Title:Acronym
Evaluation of the effects of combined consumption of test foods containing plant-derived bioactive substances on the biomarker in blood
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of combined ingestion of plant-derived bioactive substances on blood biomarker concentrations. In addition, the effect of combined ingestion of plant-derived bioactive substances on appetite will be evaluated as the secondary endpoints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood biomarker concentrations
Key secondary outcomes
Appetite score, nutrient intake
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake the test food and drink for 3 weeks
Interventions/Control_2
Intake the placebo food and drink for 3 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Subjects who are males and females over 20 years old and under 65 years old
2) Subjects who can use the electronic logbook application
3) Subjects who agree to participate in this study with a written informed consent
Key exclusion criteria
1) Those who have factors other than dietary habits that greatly affect blood biomarker concentration (Habitual drinker or smoker, those who have an infectious disease within 1 month of the start of the study, those who take antibiotics within 1 month of the start of the study, those who have chronic digestive disorders)
2) Those who have factors other than blood biomarker concentration that greatly affect appetite (Those who eat less than two meals a day on some days, those who are undergoing hormone therapy [including steroid])
3) Those who may have adverse events when collecting blood (those who are sensitive to alcohol to the extent that alcohol disinfection is difficult, those who have skin diseases on their fingers, Those who with severe anemia)
4) Those who are unable to draw the required amount of blood (100 microL) at the screening
5) Those who may develop allergies due to ingestion of the test foods
6) Subjects who regularly use medicines, health foods, and supplements (Except for those who can stop taking health foods and supplements approximately one week prior to the start of the study)
7) Those who habitually consume (at least twice a week) foods containing the same active ingredients as the test foods and beverages (Except for those who can reduce the intake of these foods to less than twice a week for both about 1 week prior to the start of the study)
8) Those who participated in other human studies within 1 month of the start of this study
9) Pregnant or lactating women, women who expect to be pregnant during this study or may be pregnant
10) Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Yusuke |
| Middle name | |
| Last name | Ushida |
Organization
KAGOME CO., LTD.
Division name
Nature & Wellness Research Department, Innovation Division
Zip code
329-2762
Address
17 Nishitomiyama, Nasushiobara, Tochigi, Japan
TEL
0287-36-2935
Yusuke_Ushida@kagome.co.jp
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
150-0002
Address
Shibuya 1-4-7 Shibuya-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.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
Leverage Brain Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.com
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
渋谷神山町診療所（東京都）/ Shibuya Kamiyamacho clinic（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 09 | Month | 21 | 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 | 09 | Month | 12 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2022 | Year | 12 | 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
| 2022 | Year | 09 | Month | 20 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055799
