UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021666 |
|---|---|
| Receipt number | R000024983 |
| Scientific Title | The pilot study of effects of food containing plant constituents. |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2016/10/26 12:54:37 |
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Basic information
Public title
The pilot study of effects of food containing plant constituents.
Acronym
The pilot study of effects of food containing plant constituents.
Scientific Title
The pilot study of effects of food containing plant constituents.
Scientific Title:Acronym
The pilot study of effects of food containing plant constituents.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the effect of food containing plant constituents in adults who have constipation tendency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
intestinal microflora
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
Food containing plant constituents, feeding three times a day for 4 weeks in term1.
Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term2.
Interventions/Control_2
Placebo food not containing plant constituents, feeding three times a day for 4 weeks in term1.
Food containing plant constituents, feeding three times a day for 4 weeks in term2.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Healthy males aged 20 or more.
2)Subjects whose defecate between 3 to 5 times in a week in a week.
3)Subjects who don't take constantly use supplements and/or functional foods (including Food for Specified Health Uses and Foods with Function Claims) affecting the intestinal regulation, cholesterol, serum triglyceride, body fat.
4)Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1) Subjects whose systolic blood pressure is less than 90 mmHg.
2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study.
4) Males whose blood was collected more than 400 mL within the last twelve weeks.
5) Females whose blood was collected more than 400 mL within the last twelve weeks.
6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks.
7) Subject who are applicable to one of the below.
a) Subject who are contracting heart, liver or kidney disease including the case of complicating disease.
b) Subjects with a previous history of cardiovascular disease.
c) Subjects who are contracting diabetes.
d) Subjects who have allergy to test food.
8) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added.
9) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added.
10) Subjects who underwent abdominal surgical operation within 6 month before test start.
11) Subjects who took antibiotics for 1 month or more within 6 month before test start.
12) Subjects who have an irregular sleep cycle, work shift or work on midnight shift.
13) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims).
14) Subjects who plan big change of lifestyle during test period.
15) Subjects with tendency of chronic diarrhea.
16) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
17) Subjects who suspected chronic or acute infectious disease.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norihito Murayama |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0588
Norihito_Murayama@suntory.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichi Wakabayashi |
Organization
Suntory Global Innovation Center Ltd.
Division name
Innovation Development Department
Zip code
Address
8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto 619-0284, Japan
TEL
050-3182-0599
Homepage URL
Kenichi_Wakabayashi@suntory.co.jp
Sponsor or person
Institute
Suntory Global Innovation Center Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
MetaGen, Inc.
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
チヨダパラメディカルケアクリニック（東京都）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | Month | 01 | 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
| 2016 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 04 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 15 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 01 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 03 | Month | 29 | Day |
Last modified on
| 2016 | Year | 10 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024983
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