UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063043 |
|---|---|
| Receipt number | R000072168 |
| Scientific Title | Exploratory study of volatile oxidized lipids contributing to off-flavor in exhaled breath and belched gas after intake of DHA-containing soft capsules |
| Date of disclosure of the study information | 2026/09/30 |
| Last modified on | 2026/09/24 17:28:42 |
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Basic information
Public title
Study of unpleasant odor-related compounds in breath and belched gas after intake of DHA-containing soft capsules
Acronym
Study of odor-related compounds in breath and belched gas after intake of DHA soft capsules
Scientific Title
Exploratory study of volatile oxidized lipids contributing to off-flavor in exhaled breath and belched gas after intake of DHA-containing soft capsules
Scientific Title:Acronym
Exploratory study of volatile oxidized lipids in exhaled breath and belched gas after intake of DHA soft capsules
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare and analyze exhaled breath and belched gas after intake of soft capsules containing DHA oils with different levels of oxidation, thereby assessing whether the post-ingestion off-flavor originates from exhaled breath or belching and identify volatile oxidized lipids that may contribute to the off-flavor.
Basic objectives2
Others
Basic objectives -Others
Exploratory assessment of the origin of off-flavor and volatile oxidized lipids associated with off-flavor following ingestion of soft capsules containing DHA oils with different levels of oxidation
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Qualitative assessment of relative comparison of chromatographic peak areas volatile oxidized lipids (VOLs) and related compounds in exhaled breath and belching following intake of soft capsules containing DHA oils with different levels of oxidation
Key secondary outcomes
Questionnaire-based assessment of the presence, intensity, and perception of off-flavor after intake of the test food
Body composition and body mass index (BMI)
Evaluation of the odor characteristics of identified candidate compounds associated with off-flavor
Identification of candidate off-flavor compounds through comparison with authentic standards
Quantitative assessment of quantifiable volatile oxidized lipids (VOLs) and related compounds
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume six soft capsules containing oxidized DHA oil (600 mg DHA in total) as a single dose on each exhaled breath and belching assessment day. A washout period of at least one day will be maintained test days.
Interventions/Control_2
Participants consume six soft capsules containing DHA oil with a minimal level of oxidation (600 mg DHA in total) as a single dose on each exhaled breath and belching assessment day. A washout period of at least one day will be maintained between test days.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Directly employed by Fuji Oil Co., Ltd. and able to visit the Tsukuba Research and Development Center on the days of breath and belched-gas collection
2)Able to provide written informed consent for participation in the study and the handling of personal information
3)Able to communicate in Japanese
Key exclusion criteria
1)Individuals who regularly take medications or supplements containing DHA or EPA
2)Current smokers
3)Individuals with respiratory disease
4)Individuals with a history of gastroesophageal reflux disease
5)Individuals currently taking anticoagulant or antiplatelet medications
6)Individuals with a history of atrial fibrillation or other arrhythmias
7)Individuals with a bleeding disorder, a tendency to bleed, or scheduled surgery
8)Individuals with allergies to seafood, algae, gelatin, or any other component of the test foods
9)Individuals currently participating in another clinical study or interventional study
10)Individuals otherwise considered ineligible for participation in this study by the occupational physician
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Mikio |
| Middle name | |
| Last name | Nakano |
Organization
Fuji Oil Co., Ltd.
Division name
Research for future creation
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
nakano.mikio@so.fujioil.co.jp
Public contact
Name of contact person
| 1st name | Mikio |
| Middle name | |
| Last name | Nakano |
Organization
Fuji Oil Co., Ltd.
Division name
Research Institute for Creating the Future
Zip code
300-2497
Address
4-3 Kinunodai, Tsukubamirai, Ibaraki, Japan.
TEL
0297-52-6325
Homepage URL
nakano.mikio@so.fujioil.co.jp
Sponsor or person
Institute
Fuji Oil Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Fuji Oil Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kyoto University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fuji Oil IRB
Address
1 Sumiyoshi-cho, Izumisano-shi, Osaka, Japan,
Tel
0297-52-6325
fujioil.irb@so.fujioil.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 | 09 | Month | 30 | 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
| 2026 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2026 | Year | 09 | Month | 24 | Day |
Last modified on
| 2026 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072168
