UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060260 |
|---|---|
| Receipt number | R000068923 |
| Scientific Title | Long-term efficacy of the test food on obesity-related indices: A randomized, double-blind, placebo-controlled parallel-group study |
| Date of disclosure of the study information | 2026/01/09 |
| Last modified on | 2026/01/05 16:19:16 |
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Basic information
Public title
Long-term efficacy of the test food on obesity-related indices: A randomized, double-blind, placebo-controlled parallel-group study
Acronym
Long-term efficacy of the test food on obesity-related indices
Scientific Title
Long-term efficacy of the test food on obesity-related indices: A randomized, double-blind, placebo-controlled parallel-group study
Scientific Title:Acronym
Long-term efficacy of the test food on obesity-related indices
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The study aims to assess the impact of prolonged intake of Trp colon-targeted delivery formulation on obesity-related indices in healthy adults, focusing on abdominal visceral fat area.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Abdominal visceral fat area
Key secondary outcomes
- Height, weight, BMI, body composition
- Waist circumference
- Abdominal subcutaneous fat area, total abdominal fat area
- Gut microbiota
- AST, ALT, fasting blood glucose, HbA1c
- Blood metabolite levels: tryptophan, indole-3-propionic acid, other tryptophan metabolites
- Intestinal barrier function: serum zonulin, serum LBP
- Oxidative stress marker: urinary 8-OHdG
- Skin questionnaire
- Brief-type self-administered diet history questionnaire
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 test food, 1 sachet daily for 16 weeks
Interventions/Control_2
Ingestion of placebo food, 1 sachet daily for 16 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Healthy adults aged 20 to under 60 at consent
2.BMI >=23 and <30 kg/m^2
3.Abdominal visceral fat area >=70 cm^2 at screening
4.Able to enter electronic diaries via PC or smartphone
5.Fully informed of study purpose and procedures, able to consent, and voluntarily agreed in writing
Key exclusion criteria
1 Currently receiving treatment for any disease with medication or Kampo (as-needed use permitted)
2 Under treatment for obesity, hyperlipidemia, lipid metabolism, or intestinal regulation
3 On physician-supervised diet or exercise therapy
4 Currently dieting or planning to start during study
5 History or presence of serious disease
6 History of gastrointestinal surgery (except appendectomy)
7 Currently taking products affecting obesity, hyperlipidemia, lipid metabolism, including quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent)
8 Currently taking other quasi-drugs, FOSHU, functional foods, health foods, or supplements (eligible if discontinued after consent)
9 Used antibiotics within 1 month before consent or plans to use during study
10 Plans for endoscopy, barium exam, H. pylori eradication, or tooth extraction during study
11 Unable to abstain from alcohol the day before testing
12 History or presence of food or drug allergies
13 >=40 g pure alcohol/day
14 >=21 cigarettes/day
15 Shift workers with night shifts
16 Plans for extended travel or major lifestyle changes during study
17 Tendency toward constipation or diarrhea
18 Unable to discontinue health foods for constipation during study
19 Unable to discontinue probiotics, prebiotics, or supplements containing live bacteria or oligosaccharides during study
20 Currently taking tryptophan supplements (eligible if discontinued after consent)
21 Currently taking protein powders or drinks (eligible if discontinued after consent)
22 Judged by investigator to have impaired renal function
23 Presence of metal implants from surgery
24 Use of pacemaker or implantable medical device
25 Claustrophobia
26 Pregnant, breastfeeding, or planning pregnancy during study
27 Participation in another clinical trial or within 4 weeks after completion, or plans to participate after consent
28 Judged by investigator to be otherwise unsuitable for study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Shinobu |
| Middle name | |
| Last name | Nishitani |
Organization
Ajinomoto Co., Inc.
Division name
Institute of Food Sciences and Technologies
Zip code
210-8681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki, 210-8681, Japan
TEL
080-1045-7701
shinobu.nishitani.vx8@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1, Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD 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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku-ku,Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.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
| 2026 | 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
| 2025 | Year | 10 | Month | 24 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 07 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | 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=R000068923
