Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063043) titled 'Study of unpleasant odor-related compounds in breath and belched gas after intake of DHA-containing soft capsules' on Sept. 30.
Study Type:
Interventional
Study Design:
Basic Design - Cross-over
Randomization - Randomized
Blinding - Double blind -all involved are blinded
Control - Active
Primary Sponsor:
Institute - Fuji Oil Co., Ltd.
Condition:
Condition - Healthy adults
Classification by malignancy - Others
Genomic information - NO
Objective:
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
Intervention:
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.
Eligibility:
Age-lower limit - 18
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 Size - 12
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072168
Disclaimer: Curated by HT Syndication.