UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060133 |
|---|---|
| Receipt number | R000068771 |
| Scientific Title | Exploratory study on the efficacy of a test food on gastric discomfort in healthy adults |
| Date of disclosure of the study information | 2025/12/19 |
| Last modified on | 2025/12/19 12:36:38 |
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Basic information
Public title
Exploratory study on the efficacy of a test food on gastric discomfort in healthy adults
Acronym
Exploratory study on the efficacy of a test food on gastric discomfort in healthy adults
Scientific Title
Exploratory study on the efficacy of a test food on gastric discomfort in healthy adults
Scientific Title:Acronym
Exploratory study on the efficacy of a test food on gastric discomfort in healthy adults
Region
| Japan |
Condition
Condition
Healthy volunteers
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the time-dependent efficacy of the test food on alleviating gastric discomfort, and to clarify participant characteristics and the methods for analyzing evaluation metrics, associated with greater efficacy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Izumo Scale Indigestion Symptom Score (sum of questions 7-9)
Key secondary outcomes
1) Izumo Scale individual item scores (questions 1-15), heartburn symptom score (sum of items 1-3), gastralgia symptom score (sum of items 4-6), Functional Dyspepsia (FD) symptom score (sum of items 4-9), constipation symptom score (sum of items 10-12), diarrhea symptom score (sum of items 13-15)
2) Visual Analog Scale (VAS) for gastric discomfort
3) Visual Analog Scale (VAS) for appetite
4) SF-36v2 Japanese Version (acute form)
5) Daily Log (test food intake, portion sizes for each meal, intake of fats and stimulants)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Ingestion of the test food for 4 consecutive weeks
Interventions/Control_2
Ingestion of placebo (control food) for 4 consecutive weeks
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
| 30 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Japanese males and females aged 30 to under 65 at the time of informed consent
2) Individuals experiencing gastric discomfort, such as early satiety or postprandial fullness while eating
3) Individuals who scored 3 points on any of items 7-9 of the Izumo Scale during screening and observation periods, and whose total score for these items was 4 points or higher
4) Individuals who received a full explanation of the study and signed the informed consent form before study initiation
5) Individuals able to compete assessments in a remote environment (e.g., via web-based questionnaires)
Key exclusion criteria
1) Individuals with organic gastrointestinal diseases (peptic ulcers, gastritis, reflux esophagitis)
2) Individuals currently receiving treatment for functional dyspepsia
3) Individuals with a current or medical history of irritable bowel syndrome
4) Individuals currently presenting with heartburn or epigastric pain as their main complaint
5) Individuals who visited a clinic for gastric symptoms within the past 6 months and did not respond to medications related to those symptoms
6) Individuals who have regularly taken medications for gastric symptoms within the past year
7) Individuals who have undergone Helicobacter pylori eradication therapy within the past 6 months, or who are H. pylori antibody-positive
8) Individuals with a history of gastrointestinal surgery
9) Individuals with pancreatic or biliary diseases, liver disease, kidney disease, severe heart disease, malignant tumors, or inborn errors of amino acid metabolism
10) Individuals with a history of treatment for anxiety disorders, depression, or sleep disorders
11) Individuals with a current or medical history of drug or alcohol dependence
12) Individuals who consume excessive amounts of alcohol
13) Individuals with highly irregular alcohol consumption habits
14) Individuals with drugs or, food allergies or those who may react to the provided food in this trial
15) Individuals with some diseases undergoing outpatient treatment
16) Individuals who regularly skip at least one meal per day
17) Individuals who Currently smoke or have smoked within the past month
18) Individuals with irregular lifestyles such as night and day shift work
19) Individuals who may be unable to maintain their daily lifestyle
20) Individuals who are pregnant, breastfeeding, or planning to become pregnant during the study period
21) Individuals who joined another clinical trial within one month before consent or plan to join one during the study
22) Individuals deemed ineligible by the principal investigator
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tetsuo |
| Middle name | |
| Last name | Yano |
Organization
Ajinomoto Co., Inc
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1,Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa 210-8681, Japan
TEL
044-223-4149
tetsuo.yano.ch8@asv.ajinomoto.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, 103-0027, Japan
TEL
03-6777-7789
Homepage URL
food-contact@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., 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
Ethics Review Committee of Watanabe Hospital
Address
1-5-16, Haneda, Ota-ku, Tokyo, 144-0043, 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(東京都) / Watanabe Hospital
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 12 | Month | 19 | 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
| 2025 | Year | 11 | Month | 12 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 12 | Month | 19 | Day |
Last modified on
| 2025 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068771
