UMIN-CTR Clinical Trial

Basic information
Public title	A study for efficacy on post-meal stomach discomfort by single intake of test food
Acronym	A study for efficacy on post-meal stomach discomfort by single intake of test food
Scientific Title	A study for efficacy on post-meal stomach discomfort by single intake of test food
Scientific Title:Acronym	A study for efficacy on post-meal stomach discomfort by single intake of test food
Region	Japan

Condition
Condition	Healthy individuals
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of improving gastric discomfort after eating the test foods.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	VAS (Fullness, Stomach feeling, appetite, general fatigue, sleepiness, defecation desire)
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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Single ingestion of study food containing 1500mg Euglena powder
Interventions/Control_2	Single ingestion of study food containing 1500mg Euglena Koji powder
Interventions/Control_3	Single ingestion of control food substance
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Healthy men and women whose age at the time of obtaining consent is between 20 and 70 2) Those who have had stomach upset after meal for the past month 3) Those who can visit the medical facility where the test is conducted 4) Those who were not judged to lack consent by the investigator
Key exclusion criteria	1) Serious liver disorder, kidney / heart disease, organ disorder, diabetes, food allergic disease, gastrointestinal disorder, anxiety disorder, depression, sleep disorder, other serious disease, or person with the history 2) Those with a history of surgery for organic diseases (peptic ulcer, gastritis, reflux esophagitis, etc.) and gastrointestinal diseases 3) Person with stomach pain as chief complaint 4) Those who received H.pylori eradication treatment within 6 months 5) Persons with a history of drug dependence or alcohol dependence 6) Persons who are allergic to drugs and food, or who are hypersensitive to the test food (eczema, nausea, diarrhea, etc.) 7) Persons with a history of mental disorders (such as depression) 8) Those who use pharmaceuticals that may affect this study, foods for specified health use, foods with functional claims, supplements, and health foods, and cannot be stopped during the study period 9) Persons who cannot stop taking specified health foods, foods with functional claims, supplements and health foods during the test period 10) Those who continue to use pharmaceuticals (OTC, internal medicines including prescription drugs) 11) Person who drinks over 1,000 mL (40 g in alcohol equivalent) per day of normal beer (5%) 12) Those who are taking warfarin 13) Pregnant and breastfeeding, and those who plan to do so 14) Person who donated blood components or 200 mL of whole blood from the month before the start of the test to the start of the test, or who donated 400 mL or more within 3 months 15) Those who have participated in other clinical trials within one month from the time of obtaining consent, or who are scheduled to participate in other clinical trials 16) Other persons who are deemed inappropriate by the study investigator to participate in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ayaka Middle name Last name Nakashima
Organization	euglena Co., Ltd.
Division name	Advanced Technology Research Department Functionality Research Section
Zip code	108-0014
Address	Shiba 5-29-11 Minato-ku, Toyko 108-0014, Japan
TEL	080-4120-9684
Email	nakashima@euglena.jp

Public contact
Name of contact person	1st name Guan Middle name Last name Lei
Organization	APO PLUS STATION CO., LTD.
Division name	CRO Department Food Test Division
Zip code	103-0027
Address	2-14-1, Nihonbashi, Chuo-ku, Tokyo, 103-0027 Japan
TEL	03-6386-8809
Homepage URL
Email	l-guan@apoplus.co.jp

Sponsor
Institute	APO PLUS STATION CO., LTD.
Institute
Department

Funding Source
Organization	euglena 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	Ageo Central Second Hospital
Address	421-1 ,Jitogata, Ageo-shi, Saitama,Japan
Tel	048-781-1101
Email	soumu@ach2.jp

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	医療法人社団愛友会　上尾中央第二病院

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 12 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	2019 Year 09 Month 06 Day
Date of IRB	2019 Year 09 Month 20 Day
Anticipated trial start date	2019 Year 10 Month 12 Day
Last follow-up date	2019 Year 10 Month 26 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 10 Month 09 Day
Last modified on	2020 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043612