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Name:
UMIN ID:

Recruitment status Suspended
Unique ID issued by UMIN UMIN000043866
Receipt No. R000050073
Scientific Title Evaluation of fermentability of barley beta-glucan using exhaled hydrogen gas
Date of disclosure of the study information 2021/04/08
Last modified on 2021/04/08

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Basic information
Public title Evaluation of fermentability of barley beta-glucan using exhaled hydrogen gas
Acronym Evaluation of fermentability of barley beta-glucan
Scientific Title Evaluation of fermentability of barley beta-glucan using exhaled hydrogen gas
Scientific Title:Acronym Evaluation of fermentability of barley beta-glucan
Region
Japan

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

Objectives
Narrative objectives1 To verify whether the test food is fermented by intestinal bacteria.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Analysis of exhaled hydrogen gas
Key secondary outcomes Abdominal symptoms

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 5
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Duration: 1 day
Test materials: barley beta-glucan
Dose: 1 g
Administration: Take once a day at once with water
Interventions/Control_2 Duration: 1 day
Test materials: barley beta-glucan
Dose: 2 g
Administration: Take once a day at once with water
Interventions/Control_3 Duration: 1 day
Test materials: barley beta-glucan
Dose: 3 g
Administration: Take once a day at once with water
Interventions/Control_4 Duration: 1 day
Test materials: fructooligosaccharide
Dose: 3 g
Administration: Take once a day at once with water
Interventions/Control_5 Duration: 1 day
Test materials: sucrose
Dose: 3 g
Administration: Take once a day at once with water
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
21 years-old <=
Age-upper limit
23 years-old >=
Gender Female
Key inclusion criteria Healthy Japanese adult females
Key exclusion criteria 1. People suffering from the following diseases
Gastrointestinal disorders, carbohydrate malabsorption, diabetes or pulmonary diseases

2. People have taken antibiotics within the last 2 weeks

3. People have a regular intake of foods containing prebiotics and probiotics
Target sample size 12

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Tanabe
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu, Jonan-ku, Fukuoka
TEL 092-851-2598
Email tanabek@nakamura-u.ac.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Tanabe
Organization Nakamura Gakuen University
Division name Faculty of Nutritional Sciences
Zip code 814-0198
Address 5-7-1 Befu, Jonan-ku, Fukuoka
TEL 092-851-2598
Homepage URL
Email tanabek@nakamura-u.ac.jp

Sponsor
Institute Nakamura Gakuen University
Institute
Department

Funding Source
Organization ADEKA Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Ethical Review Committee for Research Involving Human Subjects in Nakamura Gakuen University
Address 5-7-1 Befu, Jonan-ku, Fukuoka
Tel 092-851-2598
Email tanabek@nakamura-u.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 中村学園大学(福岡県)

Other administrative information
Date of disclosure of the study information
2021 Year 04 Month 08 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 Suspended
Date of protocol fixation
2021 Year 02 Month 04 Day
Date of IRB
2021 Year 03 Month 25 Day
Anticipated trial start date
2021 Year 04 Month 08 Day
Last follow-up date
2021 Year 12 Month 31 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 04 Month 08 Day
Last modified on
2021 Year 04 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050073

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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