UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038258 |
|---|---|
| Receipt number | R000043612 |
| Scientific Title | A study for efficacy on post-meal stomach discomfort by single intake of test food |
| Date of disclosure of the study information | 2019/10/12 |
| Last modified on | 2020/01/30 18:32:11 |
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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
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
l-guan@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043612
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