UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034451 |
|---|---|
| Receipt number | 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 10:06:12 |
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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
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
r.shimizu@tes-h.co.jp
Sponsor or person
Institute
TES Holdings Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039286
