UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000058863 |
|---|---|
| Receipt number | R000061005 |
| Scientific Title | A study to validate the effect of test drugs on tryptophan colonic delivery - A placebo controlled randomized double-blind crossover trial |
| Date of disclosure of the study information | 2026/10/01 |
| Last modified on | 2025/08/22 08:52:07 |
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Basic information
Public title
A study on colonic drug delivery
Acronym
A study on colonic drug delivery
Scientific Title
A study to validate the effect of test drugs on tryptophan colonic delivery - A placebo controlled randomized double-blind crossover trial
Scientific Title:Acronym
A study on colonic drug delivery of tryptophan
Region
| Japan |
Condition
Condition
obesity and type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Indole-3-propionic acid, a tryptophan metabolite by gut bacteria, is known to have ameliorative effects on obesity and type 2 diabetes. Therefore, the aim of this study is to elucidate the optimal formulation design to deliver tryptophan to the colon.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indole-3-propionic acid concentration in blood
Key secondary outcomes
Tryptophan concentration in blood
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Male
Key inclusion criteria
-Those who are able to eat three meals a day.
-Those who have a bowel movement once a day, basically in the morning.
-Those who are able to stay at the Aiwa Clinic from Friday night to Monday around noon.
-Those who have been fully informed of the purpose and content of the research, have the capacity to consent, and have voluntarily volunteered to participate based on a thorough understanding of the purpose and content of the research, and have given their consent to participate in the research in writing.
Key exclusion criteria
-Those who are judged to be unsuitable as research subjects in the clinical examination and vitals conducted for the screening test.
-Those who have chronic diseases, regularly use drugs or medicines, or have serious complications.
-Those who are taking health foods (including food for specified health use and functional foods) on a daily basis.
-Those who have gastrointestinal diseases that affect digestion and absorption, and those who have a history of gastrointestinal surgery.
-Those who will sweat profusely or exercise during the study period.
-Those who have a tendency to constipation or diarrhea.
-Those who cannot refrain from excessive protein intake (e.g., eating all-you-can-eat grilled meat, consuming protein drinks, etc.) during the period of this study.
-Those who have a nocturnal rhythm in their daily life.
-Those who have donated blood within 4 weeks prior to the start of the study and those who plan to donate blood during the study period and within 4 weeks of the end of the intake.
-Those who are currently participating or intend to participate in research involving the ingestion of other foods, drugs, etc., or the application of cosmetics, drugs, etc.
-Other persons who are judged by the principal investigator to be inappropriate as research subjects.
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Yoji |
| Middle name | |
| Last name | Yamada |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1 Suzukicho, Kawasaki-ku, Kawasaki, Kanagawa
TEL
090-2233-3948
youji.yamada.wn9@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Keishi |
| Middle name | |
| Last name | Kameyama |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1 Suzukicho, Kawasaki-ku, Kawasaki, Kanagawa
TEL
09045931486
Homepage URL
keishi.kameyama.hw4@asv.ajinomoto.com
Sponsor or person
Institute
Ajinomoto Co., Inc.
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
Ajinomoto Co., Inc.
Address
1-15-1 Kyobashi, Chuo-ku, Tokyo
Tel
070-1000-7637
sachiko.oka.sd9@asv.ajinomoto.com
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
| 2026 | Year | 10 | Month | 01 | 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
7
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
Completed
Date of protocol fixation
| 2023 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 15 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 20 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
No remarks
Management information
Registered date
| 2025 | Year | 08 | Month | 22 | Day |
Last modified on
| 2025 | Year | 08 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061005
