UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053012 |
|---|---|
| Receipt number | R000059456 |
| Scientific Title | Evaluation of the effect of the functional foods on intestinal absorption of risk factors for dementia |
| Date of disclosure of the study information | 2023/12/06 |
| Last modified on | 2025/09/09 11:12:53 |
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Basic information
Public title
Evaluation of the effect of the functional foods on intestinal absorption of risk factors for dementia
Acronym
Evaluation of the effect of the functional foods on intestinal absorption of risk factors for dementia
Scientific Title
Evaluation of the effect of the functional foods on intestinal absorption of risk factors for dementia
Scientific Title:Acronym
Evaluation of the effect of the functional foods on intestinal absorption of risk factors for dementia
Region
| Japan |
Condition
Condition
dementia
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of functional food on the absorption of a sugar molecule from the diet, which has been suggested to be a risk factor for dementia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Blood rare sugar molecule concentrations were measured 30 minutes before and 30, 60, 120, 180, and 240 minutes after a meal to determine the difference between the presence and absence of functional food intake.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is 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
Avoid consumption of functional foods for 6 days before the test. In addition, beverage restrictions will be imposed to avoid consumption of plant extracts from 3 days before the day of the study until the day of the study.
The functional food containing the plant extract is consumed immediately before lunch for 4 days, including the test day, starting 3 days before the start of the test. On the test day, following the intake of the functional food, 220 g of hamburger made from 100% ground beef will be consumed during lunch.
Interventions/Control_2
Avoid consumption of functional foods for 6 days before the test. In addition, beverage restrictions will be imposed to avoid consumption of plant extracts from 3 days before the day of the study until the day of the study.
On the day of the test, 220 g of hamburger made from 100% ground beef will be consumed during lunch.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Men and women between the ages of 20 and 60 with written consent
2. Persons who normally take three meals a day
3. Volunteers who voluntarily indicate their willingness to participate
4. Persons who are able to understand the purpose of this study
Key exclusion criteria
1. Persons who are participating in other clinical trials at the time of the start of this study
2. Smokers
3. Persons who are in hospital, hospitalized, or on medication
4. Persons who are regular users of medicines or supplements
5. Persons who are allergic to beef or chicken
6. Persons who have ever felt sick when having blood drawn.
7. Persons who are unable to give written consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Akira |
| Middle name | |
| Last name | Minami |
Organization
Faculty of Pharmaceutical Sciences, University of Shizuoka
Division name
Department of Biochemistry
Zip code
4228526
Address
52-1 Yada, Suruga-ku, Shizuoka City, Shizuoka Prefecture
TEL
+81542645726
aminami@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Akira |
| Middle name | |
| Last name | Minami |
Organization
Faculty of Pharmaceutical Sciences, University of Shizuoka
Division name
Department of Biochemistry
Zip code
4228526
Address
52-1 Yada, Suruga-ku, Shizuoka City, Shizuoka Prefecture
TEL
+81542645726
Homepage URL
aminami@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
Kao Corporation
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
University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka City, Shizuoka Prefecture
Tel
+81542645124
tyous10@u-shizuoka-ken.ac.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
| 2023 | Year | 12 | Month | 06 | Day |
Related information
URL releasing protocol
https://w3pharm.u-shizuoka-ken.ac.jp/biochem/intro.html
Publication of results
Unpublished
Result
URL related to results and publications
https://w3pharm.u-shizuoka-ken.ac.jp/biochem/intro.html
Number of participants that the trial has enrolled
15
Results
A statistically significant difference was confirmed between the two groups.
Results date posted
| 2025 | Year | 09 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Subject Selection
Subjects were recruited from among staff and students at the Faculty of Pharmaceutical Sciences, Shizuoka Prefectural University. Participants who met the following criteria and provided written consent were included.
Subject Inclusion Criteria
1. Males and females aged 20 years or older but under 60 years who provided written consent
2. Individuals who normally consume three meals per day
3. Volunteers who expressed a willingness to participate voluntarily
4. Individuals capable of understanding the purpose of this study
Exclusion Criteria
1. Individuals participating in other clinical trials at the start of this study
2. Smokers
3. Individuals undergoing outpatient treatment, hospitalization, or drug therapy
4. Individuals regularly taking pharmaceuticals or supplements
5. Individuals with allergies to beef or chicken
6. Individuals who have experienced discomfort during blood collection
7. Individuals unable to provide consent via the consent form
Participant flow
No participants withdrew or dropped out of the trial.
Furthermore, considering the burden on participants, the trial was terminated with 15 subjects after achieving the original objectives.
Adverse events
Adverse events: None
Outcome measures
Concentration of glycan-containing molecules in blood.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 26 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 13 | Day |
Last follow-up date
| 2024 | 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
| 2023 | Year | 12 | Month | 06 | Day |
Last modified on
| 2025 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059456
