UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of changes in intestinal flora in healthy person with half-elemental diet (900 kcal / day)
Title of the study (Brief title)	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	Tadakazu Hisamatsu
Organization	Kyorin University School of Medicine
Division name	The Third Department of Internal Medicine
Address	6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL	+81-422-47-5511
Email	thisamatsu@ks.kyorin-u.ac.jp

Public contact
Name of contact person	Daisuke Saito
Organization	Kyorin University School of Medicine
Division name	The Third Department of Internal Medicine
Address	6-20-2 Shinkawa, Mitaka-shi, Tokyo 181-8611, Japan
TEL	+81-422-47-5511
Homepage URL
Email	straw@zb3.so-net.ne.jp

Sponsor
Institute	Kyorin University School of Medicine
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 01 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035761