UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053269 |
|---|---|
| Receipt number | R000060799 |
| Scientific Title | Research on appetite suppressive effect of Allulose intake |
| Date of disclosure of the study information | 2024/01/09 |
| Last modified on | 2024/01/05 12:01:07 |
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Basic information
Public title
Research on appetite suppressive effect of Allulose intake
Acronym
Research on appetite suppressive effect of Allulose intake
Scientific Title
Research on appetite suppressive effect of Allulose intake
Scientific Title:Acronym
Research on appetite suppressive effect of Allulose intake
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To study the alterations in eating behavior among healthy individuals when consuming Allulose-containing food
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite
Feeling of fullness
Key secondary outcomes
Food intake
Eating time
Eating rate
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
The food containing Allulose
Interventions/Control_2
Placebo
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 and Female
Key inclusion criteria
Healthy adults aged 20-40 years old
Key exclusion criteria
1)Regularly use excessive alcohol and cigarette
2)Extremely irregular diet
3)Taking ingest foods for specified health use, foods with functional claims, and other foods and beverages with possible functionalities
4)Willing to become pregnant during pregnancy, breastfeeding, or during the study period
5)Participated in other clinical trials or plan to participate during this research period
6)Diagnosed with some kind of illness and are being treated or taking medication
7)Serious illness
8)Persons who will not be judged suitable to the participants by the investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masayuki |
| Middle name | |
| Last name | Yamasaki |
Organization
Ryukoku University
Division name
Faculty of Agriculture
Zip code
520-2194
Address
1-5, Yokotani, Seta Oe-cho, Otsu, Shiga
TEL
077-543-5111
a15035@mail.ryukoku.ac.jp
Public contact
Name of contact person
| 1st name | Reika |
| Middle name | |
| Last name | Nishida |
Organization
UHA Mikakuto Co., Ltd
Division name
Global Healthcare Research Laboratory
Zip code
540-0016
Address
4-12, Kanzaki-cho, Osaka-shi, Osaka
TEL
06-6767-6020
Homepage URL
nisidar@uha-mikakuto.co.jp
Sponsor or person
Institute
UHA Mikakuto Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
UHA Mikakuto 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
Ryukoku University
Address
1-5, Yokotani, Seta Oe-cho, Otsu, Shiga
Tel
077-543-5111
a15035@mail.ryukoku.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2023-26
Org. issuing International ID_1
Ryukoku University
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 09 | 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
| 2023 | Year | 11 | Month | 29 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 12 | 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 | 01 | Month | 05 | Day |
Last modified on
| 2024 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060799
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
