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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034451
Receipt No. R000039286
Scientific Title A study for an effect of the food containing plant-derived ingredient on serum fat.
Date of disclosure of the study information 2018/10/22
Last modified on 2019/01/07

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Basic information
Public title A study for an effect of the food containing plant-derived ingredient on serum fat.
Acronym Effect of plant-derived ingredient on serum fat.
Scientific Title A study for an effect of the food containing plant-derived ingredient on serum fat.
Scientific Title:Acronym Effect of plant-derived ingredient on serum fat.
Region
Japan

Condition
Condition Nothing (Healthy adults)
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy of the plant-derived ingredient on post prandial serum fat.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Post prandial serum fat
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
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 Single intake of active food (product code: Q-001) > wash out more than 5 days > Single intake of placebo food (product code: P-001)
Interventions/Control_2 Single intake of placebo food (product code: P-001) > wash out more than 5 days > Single intake of active food (product code: Q-001)
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
30 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 1.Age>=30 and <60 years
2.BMI>=18.5 and < 30 kg/m2
Key exclusion criteria 1.Person who is presence of liver, kidney, and heart disease; respiratory, endocrine, metabolic, nervous system, or cognitive disorders; or diabetes or other diseases.
2.Person who has surgery within 2 months before the trial.
3.Person who taking medications for hyperglycaemia, lipid metabolism, or hypertension.
4.Person who taking supplements or foods that affect this trial.
5.Person who experienced unpleasant feeling during drawing blood.
6.Person who has donated over 200 mL blood within one month.
7.Person whose serum TG is over 200 mg/dL.
8.Person who is heavy smoker
9.Person who has food allergies.
10.Person who is shift worker.
11.Person who plans business trip lasting 5 consecutive days or more.
12.Person who participating or planning to participating in other clinical trial.
13.Person who can't agree informed consent.
14.Person who is pregnant or lactating
15.Person who is judged to be inappropriate for this study by the supervising physician or principal investigator for other reasons.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takahiro Ono
Organization Ueno-Asagao Clinic
Division name Head
Zip code
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL +81-3-6240-1162
Email t.ono@ueno-asagao.clinic

Public contact
Name of contact person
1st name
Middle name
Last name Ryoma Shimizu
Organization TES Holdings Co., Ltd.
Division name Administrative Department of Clinical Trials
Zip code
Address Kairaku Building 6F, 2-7-5, Higashiueno, Taito-ku, Tokyo, 110-0015, JAPAN
TEL +81-3-6801-8480
Homepage URL
Email r.shimizu@tes-h.co.jp

Sponsor
Institute TES Holdings Co., Ltd.
Institute
Department

Funding Source
Organization Kao Corporation
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 うえのあさがおクリニック(東京都)

Other administrative information
Date of disclosure of the study information
2018 Year 10 Month 22 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 Completed
Date of protocol fixation
2018 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 10 Month 11 Day
Last modified on
2019 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039286

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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