UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038831
Receipt No. 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

* 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 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
Email 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
Email yssuzuki@juntendo.ac.jp

Sponsor
Institute Juntendo University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044279

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.