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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035763
Receipt No. R000040738
Scientific Title An evaluation of the change of plasma DHA concentration after the ingestion of DHA containing food.
Date of disclosure of the study information 2019/02/04
Last modified on 2019/06/11

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Basic information
Public title An evaluation of the change of plasma DHA concentration after the ingestion of DHA containing food.
Acronym An evaluation of the change of plasma DHA concentration after the ingestion of DHA containing food.
Scientific Title An evaluation of the change of plasma DHA concentration after the ingestion of DHA containing food.
Scientific Title:Acronym An evaluation of the change of plasma DHA concentration after the ingestion of DHA containing food.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To Confirm the change of plasma DHA concentration after the ingestion of DHA containing food
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma DHA concentration
Key secondary outcomes Plasma EPA concentration
Plasma omega 3-fatty acids concentration(DHA and EPA)
Plasma CCK concentration
Plasma GLP-2 concentration

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Subjects receive a single dose of the active food. After the washout period (more than 6 days), subjects receive a single dose of the placebo food.
Interventions/Control_2 Subjects receive a single dose of the placebo food. After the washout period (more than 6 days), subjects receive a single dose of the active food.
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
35 years-old >=
Gender Male
Key inclusion criteria 1) Subjects giving written informed consent
2)Males aged 20 to 35 years old when consent acquisition
3)Subjects whose body mass index (BMI) is from 18.5 kg/m2 to 25.0 kg/m2
Key exclusion criteria 1)Subjects who routinely use pharmaceuticals, quasi-drugs and dietary supplement, and consume food for specified health uses more than two days per week
2) Subjects who have chronic diseases necessitating treatments and/or medications
3) Subjects who have significant abnormal blood pressure or blood test score
4) Subjects who have food allergy
5) Subjects who have lactose intolerance
6)Subjects who have digestive diseases or who received digestive surgical procedures
7) Subjects who are habitual smokers within a month of study enrollment
8) Subjects who donate 200 mL of blood within a month, or 400 mL of blood within three month
9) Subjects who participate in other clinical trials within the past month or have plans to participate in other clinical trials during this study period
10)Subjects who determine ineligible by the principal investigator or sub-investigator
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Keiko Kawahata
Organization Meiji Co.,Ltd.
Division name Food Science & Technology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5847
Email keiko.kawahata@meiji.com

Public contact
Name of contact person
1st name
Middle name
Last name Yusuke Omae
Organization Meiji Co.,Ltd.
Division name Food Science & Technology Research Laboratories, R&D Division
Zip code
Address 1-29-1 Nanakuni, Hachiouji, Tokyo
TEL 042-632-5847
Homepage URL
Email yuusuke.ohmae@meiji.com

Sponsor
Institute Meiji CO.,Ltd.
Institute
Department

Funding Source
Organization Meiji CO.,Ltd.
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
Address
Tel
Email

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 チヨダパラメディカルケアクリニック

Other administrative information
Date of disclosure of the study information
2019 Year 02 Month 04 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 No longer recruiting
Date of protocol fixation
2019 Year 01 Month 29 Day
Date of IRB
2019 Year 01 Month 17 Day
Anticipated trial start date
2019 Year 02 Month 03 Day
Last follow-up date
2019 Year 03 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 02 Month 04 Day
Last modified on
2019 Year 06 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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