UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056748 |
|---|---|
| Receipt number | R000064832 |
| Scientific Title | A Study on the Effect of Test Food on Appetite -A Randomized, Double-blind, Placebo-controlled, Triple-cross-over Study- |
| Date of disclosure of the study information | 2025/01/17 |
| Last modified on | 2025/01/16 17:08:29 |
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Basic information
Public title
A Study on the Effect of Test Food on Appetite
-A Randomized, Double-blind, Placebo-controlled, Triple-cross-over Study-
Acronym
A Study on the Effect of Test Food on Appetite
Scientific Title
A Study on the Effect of Test Food on Appetite
-A Randomized, Double-blind, Placebo-controlled, Triple-cross-over Study-
Scientific Title:Acronym
A Study on the Effect of Test Food on Appetite
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To confirm the effect of test food on appetite
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Appetite (hunger, fullness, prospective consumption, satiety) score on the Japanese version of appetite sensations questionnaire using visual analogue scales (VAS) after the single ingestion.
Key secondary outcomes
The blood concentration of on appetite related hormones after the single ingestion.
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
3
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Test foods high-dose, single ingestion. Wash out. Test foods low-dose, single ingestion. Wash out. Control foods, single ingestion.
Interventions/Control_2
Test foods low-dose, single ingestion. Wash out. Control foods, single ingestion. Wash out. Test foods high-dose, single ingestion.
Interventions/Control_3
Control foods, single ingestion. Wash out. Test foods high-dose, single ingestion. Wash out. Test foods low-dose, single ingestion.
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Healthy Japanese males and females aged 20 to 64 years-old.
2) Subjects who have no habit of smoking.
3) Subjects who do not habitually consume a large amounts of alcohol.
4) Subjects whose BMI are less than 30.
5) Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
Subjects(who)
1) contract or have a history of serious diseases (eg, liver, kidney, digestive, heart, respiratory, endocrine, metabolic, skeletal muscle and/or tendon disease)
2) have a chronic disease and regularly use medications.
3) contract or have a surgical history of digestive disease affecting digestion and absorption.
4) have declared allergic reaction to ingredients contained in test foods or loading foods.
5) can't stop using supplements, and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims, or enriched foods or nutritional supplements which contain proteins and/or amino acids).
6) were judged as unsuitable for the current study by screening tests.
7) are diagnosed as anemic by the screening tests and unsuitable for frequent blood sampling.
8) have had diarrhea within the last 1 week prior to the screening tests.
9) can't stop drinking from 2 days before each measurement.
10) pregnant or breastfeed or planning to become pregnant during this study.
11) have a habit of skipping breakfast.
12) have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week.
13) are shiftworker and/or midnight-shift worker.
14) are under treatment for or have a history of drug addiction and/or alcoholism.
15) have donated over 200 mL of blood and/or blood components within the last 1 month or over 400 mL of blood and/or blood components within the last 3 months prior to the current study.
16) are participating in or willing to participate in other clinical studies.
17) are judged as unsuitable for the current study by the investigator for other reasons.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13-4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Clinical Trial Management department
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
eigyou27@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
TOYO SHINYAKU 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
Ethical Committee of Kobuna Orthopedics Clinic
Address
5-656-17 Joto-machi, Maebashi-shi, Gunma
Tel
027-212-5608
sagawa@mc-connect.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 17 | 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 | 08 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 17 | Day |
Last modified on
| 2025 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064832
