UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053670 |
|---|---|
| Receipt number | R000060556 |
| Scientific Title | Evaluating the Effects of Test Food Consumption on Pre- and Post-meal Hunger |
| Date of disclosure of the study information | 2024/02/21 |
| Last modified on | 2024/03/12 14:35:21 |
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Basic information
Public title
Evaluating the Effects of Test Food Consumption on Pre- and Post-meal Hunger
Acronym
Evaluating the Effects of Test Food Consumption on Pre- and Post-meal Hunger
Scientific Title
Evaluating the Effects of Test Food Consumption on Pre- and Post-meal Hunger
Scientific Title:Acronym
Evaluating the Effects of Test Food Consumption on Pre- and Post-meal Hunger
Region
| Japan |
Condition
Condition
Male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of single intake of the test food on appetite in elderly individuals, with the aim of developing ingredients that can stimulate the declining appetite associated with aging.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Four items related to appetite (Visual Analogue Scale, VAS)
Key secondary outcomes
Four items regarding craving for specific foods (Visual Analogue Scale, VAS)
One item related to spiciness (likert scale)
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
Intake of test food product 1.
Interventions/Control_2
Intake of test food product 2.
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
| 50 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Men and women aged between 50 and 70 years at the time of consent acquisition.
2. Subjects who regularly consume three solid meals per day.
3. Subjects who can consume four sticks of a load meal (Calorie Mate) in a single sitting.
4. Subjects who are able to participate in a test involving an overnight stay of 1 night and 2 days.
5. Subjects who can give informed consent to partake in this study, after being provided with an explanation of the protocol detail.
Key exclusion criteria
1. Subjects who are taking medications (related to diabetes, gastrointestinal organs, or metabolism) more than twice a week, which may potentially affect the trial, and cannot restrict their use during the study period.
2. Subjects with dislikes or allergies to the ingredients of the test food.
3. Subjects with previous and/or current medical history of diabetes.
4. Subjects with previous and/or current medical history of gastrointestinal diseases and/or surgery.
5. Subjects with current immune diseases and/or those taking related medications.
6. Subjects who are participating in the other clinical trials and/or who have participated in the other clinical trials within 4 weeks prior to the current trial and/or who are planning to participate in the other clinical trials.
7. Subjects with previous and/or current medical history of serious diseases in heart, liver, kidney and/or digestive organs.
8. Subjects who are pregnant, breastfeeding, or intending to become pregnant during trial period.
9. Subjects with allergies to medications and/or food.
10. Subjects deemed unsuitable for participation in the trial by the principal investigator or sub-investigator.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Ouchi |
Organization
Seisyukai 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
chiken@seishukai.or.jp
Sponsor or person
Institute
Seisyukai Clinic, Seishukai Medical corporation
Institute
Department
Personal name
Funding Source
Organization
House Foods Group Inc.
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
Seishukai Clinic Institutional Review Board
Address
3-18-5 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
| 2024 | Year | 02 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 30 | 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 | 02 | Month | 21 | Day |
Last modified on
| 2024 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060556
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