UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053245 |
|---|---|
| Receipt number | R000060759 |
| Scientific Title | Exploratory study on the effect of food material processing on the absorption of functional lipids |
| Date of disclosure of the study information | 2023/12/27 |
| Last modified on | 2024/06/11 11:52:42 |
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Basic information
Public title
Exploratory study on the effect of food material processing on the absorption of functional lipids
Acronym
Exploratory study on the effect of food material processing on the absorption of functional lipids
Scientific Title
Exploratory study on the effect of food material processing on the absorption of functional lipids
Scientific Title:Acronym
Exploratory study on the effect of food material processing on the absorption of functional lipids
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of the food material processing in the absorption of functional lipids by comparing the absorption of functional lipids with/ without processing in a single intake in healthy adult
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood total ketone bodies (delta AUC)
Key secondary outcomes
blood metabolites, metabolic markers (AUC, delta AUC, Cmax, delta Cmax, Tmax)
blood ketone bodies (beta-Hydroxybutyric acid, acetoacetic acid, and the total value)
medium-chain fatty acid (octanoic acid, decanoic acid)
acyl-ghrelin and des-acyl ghrelin
Glucose
insulin
abdominal symptoms questionnaire
Rating scale about gastralgia, epigastric fullness, nausea bloating, appetite for the foods
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
1)Single intake of placebo (control food)
2)Washout period is for more than 6 days
3)Single intake of reference food
4)Washout period is for more than 6 days
5)Single intake of test food
6)Washout period is for more than 6 days
7)Single intake of placebo (control food)
Interventions/Control_2
1)Single intake of placebo (control food)
2)Washout period is for more than 6 days
3)Single intake of reference food
4)Washout period is for more than 6 days
5)Single intake of placebo (control food)
6)Washout period is for more than 6 days
7)Single intake of test food
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
| 40 | years-old | > |
Gender
Male
Key inclusion criteria
1) Subjects who have been fully informed of the purpose and content of the study, have the capacity to consent, volunteer of their own free will with full knowledge of the content, and consent to participate in the study
2) Males in the age between 20 and 40 years
3) Subjects whose BMI 18.5 kg/m2 or more and less than 25.0 kg/m2
Key exclusion criteria
1)Subjects who routinely take pharmaceuticals, quasi-drugs, dietary supplement, foods for specified health uses, medium-chain triglycerides or coconut oil for more than two days per week within a month before the screening test
2)Subjects judged by the principal investigator to have serious chronic illnesses or symptoms
3)Subjects judged by the principal investigator to have abnormalities in lipid metabolism, sugar metabolism, liver function, or kidney function
4)Subjects who have food allergies
5)Subjects who are intolerant to lactose
6)Subjects who have had digestive system surgery
7)Subjects who smoked within a month before the screening test
8)Subjects who were donated more than 200 mL of blood within a month or more than 400 mL within 3 months before the screening test
9)Subjects who participated in other clinical trials within a month before the screening test or plan to participate other clinical trials during this study period
10)Subjects who are judged as ineligible for the study by the investigator
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Watanabe |
Organization
Watanabe Hospital
Division name
Surgery
Zip code
144-0043
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
TEL
03-3741-0223
Wnb.cto@gmail.com
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Sakata |
Organization
APO PLUS STATION CO., LTD.
Division name
Clinical Operations Dept., CRO Business div.
Zip code
103-0027
Address
2-14-1, Nihonbashi, Chuo-ku, Tokyo, Japan
TEL
03-6386-8809
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, JAPAN
Tel
03-3741-0223
food-contact@apoplus.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
医療法人社団 渡辺病院(Watanabe Hospital)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 12 | Month | 27 | 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 | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 12 | Month | 27 | Day |
Last modified on
| 2024 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060759
