UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044511 |
|---|---|
| Receipt number | R000050852 |
| Scientific Title | Evaluation of changes in gut environment and biological barrier parameters by test-food intake |
| Date of disclosure of the study information | 2021/06/14 |
| Last modified on | 2022/07/04 21:33:24 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of changes in gut environment and biological barrier parameters by test-food intake
Acronym
Evaluation of changes in gut environment and biological barrier parameters by test-food intake
Scientific Title
Evaluation of changes in gut environment and biological barrier parameters by test-food intake
Scientific Title:Acronym
Evaluation of changes in gut environment and biological barrier parameters by test-food intake
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the effects of the test-food consumed for 4 weeks on gut environment and biological barrier index.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut environment (gut microbiota and gut metabolites)
Key secondary outcomes
1. Defecation status (the number of days, frequency, quantity, property, color, feeling of incomplete evacuation, abdominal pain, fecal odor)
2. Biological barrier parameters (salivary IgA level, salivary IgA concentration, ratio of polymerized IgA in saliva, salivary mucin level, salivary mucin concentration, saliva volume, salivary chemokine ligand 28 level, salivary chemokine ligand 28 concentration, serum LPS binding protein concentration, serum zonulin concentration, serum high-sensitivity C-reactive protein concentration, serum inflammatory cytokines concentration, plasma metabolites)
3. Changes in clinical examination value
4. POMS2 short version
5. SF-36v2 Japanese version
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Consume 100 g of the test food every morning for 4 weeks.
Interventions/Control_2
Consume 100 g of the control food every morning for 4 weeks.
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
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged more than or equal to 20, and less than 40 when obtaining the consent.
(2) Subjects without chronic diarrhea symptoms.
(3) 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 who have a plan or who have taken medication which would affect the trial result (e.g. drugs for anti-allergic, intestinal disorder, and laxative) after pre-inspection 1.
(2)Subjects who have a plan or who have taken antibiotics within 3 months prior to the trial.
(3)Subjects who are regularly consuming food for specified health uses (FOSHU), food with function claims, supplement and/or health foods which would affects the trial results for more than 3 days a week.
(4)Subjects who have removed tonsils and/or appendix.
(5)Subjects whose roomer is planning to join this trial.
(6)Subjects who have received the surgery which would affect the trial result (e.g. colonoscopy, removal of gallstones and/or gall bladder, or gastric bypass surgery) within half a year before obtaining the consent.
(7)Pregnant, possibly pregnant, or lactating women.
(8)Subjects who have current medical history/anamnesis of severe cardiac, hepatic, renal or digestive diseases.
(9)Subjects who take excessive alcohol.
(10)Subjects who would encounter a dramatic change in their living environment (e.g. relocation, job-changing).
(11)Subjects with irregular dietary habits or lifestyle (e.g. alternative work schedule, graveyard shift).
(12)Subjects who are allergic to drugs or foods.
(13)Subjects who are participating or have been participated to other clinical tests with specific medicine/food within the last 4 weeks before this trial, or planning to join those after giving informed consent.
(14-16)Subjects who donated their blood components and/or whole blood prior to the pre-inspection as follows;
- any subjects: 200 mL within a month
- males: 400 mL within the last 3 months
- females: 400 mL within the last 4 months.
(17-18)Subjects whose collected blood volume within the last 12 months would reach to following criteria after adding the blood collection in this study;
- males: 1,200 mL
- females: 800 mL
(19)Others who have been determined ineligible by principal/sub investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriyuki |
| Middle name | |
| Last name | Kohda |
Organization
Otsuka Pharmaceutical Co., Ltd.
Division name
Otsu Neutraceuticals Research Institute
Zip code
520-0002
Address
3-31-13, Saigawa, Otsu, Shiga, Japan
TEL
+81-775-21-8835
Kohda.Noriyuki@otsuka.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
+81-3-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Otsuka Pharmaceutical 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
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
+81-3-5297-5548
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 06 | Month | 14 | 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
| 2021 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 10 | Month | 05 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 11 | Day |
Last modified on
| 2022 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050852
