UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038831 |
|---|---|
| Receipt number | R000044279 |
| Scientific Title | Pilot study on the effects of adlay and peanuts on the intestinal microbiota |
| Date of disclosure of the study information | 2019/12/09 |
| Last modified on | 2020/06/09 10:20:13 |
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Basic information
Public title
Pilot study on the effects of adlay and peanuts on the intestinal microbiota
Acronym
Pilot study on the effects of adlay and peanuts on the intestinal microbiota
Scientific Title
Pilot study on the effects of adlay and peanuts on the intestinal microbiota
Scientific Title:Acronym
Pilot study on the effects of adlay and peanuts on the intestinal microbiota
Region
| Japan |
Condition
Condition
Healthy male adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of adlay and peanuts on the intestinal microbiota
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal microbiota - Pre and post of the intervention
Key secondary outcomes
Serum metabolome - Pre and post of the intervention
Peripheral lymphocytes - Pre and post of the intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Steamed adlay, 160 g/day, 7 days
Interventions/Control_2
Peanuts, 160 g/day, 7 days
Interventions/Control_3
No test food, 7 days
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
Key inclusion criteria
1. Those who can safely complete the study in good physical condition.
2. Those who have received an explanation of the study in advance and are able to understand the content and agree with the purpose.
3. Those who participate in the study voluntary with written consent.
Key exclusion criteria
1. Those receiving treatment or prescribed drug from a medical doctor.
2. Those with severe cardiovascular disorder, liver dysfunction, renal dysfunction, respiratory disorder, endocrine disorder, metabolic disorder, or history of these.
3. Those who may cause allergies related to adley or peanuts.
4. Those whose blood drawn (such as blood donation) exceeding 200 mL within 1 month before the start of this study, or 400 mL within 3 months.
5. Those who participated in another clinical trial within the past 3 months or who are currently participating in another clinical trial.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1, Hiragagakuenndai, Inzai, Chiba
TEL
+81476981001
yssuzuki@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Yoshio |
| Middle name | |
| Last name | Suzuki |
Organization
Juntendo University
Division name
Graduate School of Health and Sports Science
Zip code
270-1695
Address
1-1, Hiragagakuenndai, Inzai, Chiba
TEL
+81476981001
Homepage URL
yssuzuki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
The National Agriculture and Food Research Organization (NARO)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Juntendo University Graduate School of Sports and Health Science
Address
1-1, Hiragagakuendai, Inzai, Chiba 270-1695
Tel
+81476981001
sc-kyomu@juntendo.ac.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
田村医院（茨城県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 12 | Month | 09 | 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 | 10 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 06 | 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 | 12 | Month | 09 | Day |
Last modified on
| 2020 | Year | 06 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044279
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
