UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056398 |
|---|---|
| Receipt number | R000064416 |
| Scientific Title | Comparative test of the amount of food component absorbed depending on the intake time of day (morning, midday or evening): open-label, crossover trial |
| Date of disclosure of the study information | 2025/01/13 |
| Last modified on | 2024/12/09 10:25:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparative test of the amount of food component absorbed depending on the time of intake
Acronym
Comparative test of the amount of food component absorbed depending on the time of intake
Scientific Title
Comparative test of the amount of food component absorbed depending on the intake time of day (morning, midday or evening): open-label, crossover trial
Scientific Title:Acronym
Comparative test of the amount of food component absorbed depending on the intake time of day (morning, midday or evening)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effect of intake time on the absorption of food component.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Area under the food component concentration curve (AUC) in the serum triglyceride-rich lipoprotein fraction after ingestion of the test food and the change of AUC.
Key secondary outcomes
Concentration of the food component in the serum triglyceride-rich lipoprotein fraction after ingestion of the test food and the change from before ingestion.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
A single ingestion of the test food (200 mL) at morning.
Interventions/Control_2
A single ingestion of the test food (200 mL) at midday.
Interventions/Control_3
A single ingestion of the test food (200 mL) at evening.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Healthy people aged 20 to 39 years.
2. Who agree to participate in the trial and have completed a medical interview and pre-test.
Key exclusion criteria
1. Whose body mass index (BMI) is less than 18.5 or above 25.
2. Who have a history of major surgery on the digestive system (except appendicitis).
3. Who visit the hospital for treatment of illnesses or receiving medication.
4. Lactating, pregnant or planning to be pregnant during this trial.
5. Who have allergic reaction to test foods.
6. Smokers (who have smoked within the last 6 months).
7. Who have irregular lifestyles, such as shift workers and late-night workers.
8. Who are not in the habit of eating three meals a day (breakfast, lunch and dinner) regularly.
9. Who consume vegetable or vegetable-fruit drinks on a daily basis (approx. three times a week or more).
10. Who have given blood in the last six months.
11. Who have difficulty having blood drawn.
12. Who have participated in other human trials within one month.
13. Who are judged unsuitable for this trial by the principal investigator.
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Shigenori |
| Middle name | |
| Last name | Suzuki |
Organization
KAGOME CO., LTD.
Division name
Diet & Well-being Research Institute
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 | Hayato |
| Middle name | |
| Last name | Ouchi |
Organization
Seishukai Clinic, Seishukai Medical corporation
Division name
Clinical trial division
Zip code
111-0036
Address
3-18-5, Matsugaya, Taito-ku, Tokyo
TEL
03-5827-0930
Homepage URL
h-ouchi@seishukai.or.jp
Sponsor or person
Institute
KAGOME CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
CPCC Company Limited
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Seishukai Clinic Institutional Review Board
Address
Matsugaya, Taito-ku, Tokyo
Tel
03-5827-0930
t-takahama@seishukai.or.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
| 2025 | Year | 01 | Month | 13 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 29 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2025 | Year | 01 | Month | 13 | Day |
Last follow-up date
| 2025 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064416
