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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038580
Receipt No. R000043874
Scientific Title Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Date of disclosure of the study information 2019/11/14
Last modified on 2019/12/29

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Basic information
Public title Absorbency confirmation test of food ingredients
Acronym Absorbency confirmation test of food ingredients
Scientific Title Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Scientific Title:Acronym Absorptivity confirmation test in single ingestion of food ingredients for healthy adults
Region
Japan

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

Objectives
Narrative objectives1 To compare blood kinetics of food ingredients with control ingredients in healthy adult male
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of blood kinetics of food ingredients with control ingredients
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
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 Intake of test food (single ingestion) - washout period - control food (single ingestion)
Interventions/Control_2 Intake of control food (single ingestion) - washout period - test food (single ingestion)
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
65 years-old >
Gender Male
Key inclusion criteria Healthy males from 20 to under 65 years of age
Key exclusion criteria (1) Subjects who routinely use health food containing participating component
(2) Subjects who cannot carry out inspection procedure as prescribed
(3) Subjects who have under treatment or a history of serious disease
(4) Subjects having possibilities for emerging allergy related to the test food
(5) Subjects who donated over 200mL blood or blood components within the last one month to the current study.
(6) Subjects who donated over 400mL blood within the last three months to the current study.
(7) Subjects who will be collected over 1200mL blood, when the sampling amounts within the last twelve months are adding to the planned sampling amounts of this study.
(8) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(9) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(10) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(11) Subjects judged as unsuitable for the current study by the investigator
Target sample size 8

Research contact person
Name of lead principal investigator
1st name Masamitsu
Middle name
Last name Moriwaki
Organization Taiyo Kagaku Co., Ltd.
Division name Nutrition division
Zip code 510-0844
Address 1-3, Takara-cho, Yokkaichi-shi, Mie
TEL 059-347-5411
Email mmoriwaki@taiyokagaku.co.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Nakagawa
Organization Taiyo Kagaku Co., Ltd.
Division name Nutrition division
Zip code 510-0844
Address 1-3, Takara-cho, Yokkaichi-shi, Mie
TEL 059-347-5411
Homepage URL
Email rnakagawa@taiyokagaku.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization Taiyo Kagaku 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 Aisei Hospital Ueno Clinic Research Ethics Committee
Address 2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel 03-6455-0880
Email t.saito@ttc-smo.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
2019 Year 11 Month 14 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 8
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
2019 Year 11 Month 14 Day
Date of IRB
2019 Year 11 Month 14 Day
Anticipated trial start date
2019 Year 11 Month 15 Day
Last follow-up date
2019 Year 11 Month 29 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 11 Month 14 Day
Last modified on
2019 Year 12 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043874

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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