UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031920 |
|---|---|
| Receipt number | R000035761 |
| Scientific Title | Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day) |
| Date of disclosure of the study information | 2018/03/31 |
| Last modified on | 2019/01/18 14:39:57 |
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Basic information
Public title
Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Acronym
Evaluation of half-ED
Scientific Title
Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Scientific Title:Acronym
Evaluation of half-ED
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the change of intestinal flora by healthy persons with Half-ED (900 kcal / day) for 2 weeks, and aim to acquire basic data for elucidating the mechanism of action of nutritional therapy and develop it into the next research.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of intestinal flora change by combining analysis results below.
1) fecal analysis (collected at 2, 4, 6 week)
16S metagenomic analysis, metabolome analysis
2) Blood biochemistry (collected at 2, 4, 6 weeks)
nutritional indicators (ALB, TP, TC), amino acids, fatty acids
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1) Dietary guidance period (2 weeks)
Provide meal guidance by meal instruction instructor.
2) Half-ED period (2 weeks)
Reduce normal meal volume to about half and administer ED 900 kcal/day.
3) Normal diet period (2 weeks)
Return to normal meal intake.
Interventions/Control_2
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 and Female
Key inclusion criteria
Healthy person
Key exclusion criteria
Exclusion criteria are shown below.
1) Person with history of IBD
2) Person who underwent laparotomy surgery within half a year from the start of the study
3) Person with taking antibiotics within half a year of start the study
4) Major drinkers
5) Person with regularly taking medications
6) Person who can not refrain from intake of foods, supplements, medicines that affect the intestinal environment during the test period
7) Person with metabolism abnormality such as diabetes
8) Person with amino acid metabolic abnormality
9) Person with history of hypersensitivity to the study drug
10) Person with pregnancy / breast-feeding
11) Person who plans to change life style significantly during the examination period
12) Person who has chronic diarrhea easily
13) Person who participated in other clinical trials within the past 3 months
14) Person who can not obtain consent of participation in this clinical study
15) Person who is judged by study responsible doctor as inappropriate as subject
Target sample size
4
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadakazu Hisamatsu |
Organization
Kyorin University School of Medicine
Division name
The Third Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL
+81-422-47-5511
thisamatsu@ks.kyorin-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Daisuke Saito |
Organization
Kyorin University School of Medicine
Division name
The Third Department of Internal Medicine
Zip code
Address
6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL
+81-422-47-5511
Homepage URL
straw@zb3.so-net.ne.jp
Sponsor or person
Institute
Kyorin University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
EA Pharma 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
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
| 2018 | Year | 03 | Month | 31 | 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 | 01 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2019 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
| 2019 | Year | 01 | Month | 18 | Day |
Date trial data considered complete
| 2019 | Year | 01 | Month | 18 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 18 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 27 | Day |
Last modified on
| 2019 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035761
