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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023480
Receipt No. R000027027
Scientific Title A clinical study on the effects of beverage containing probiotics on glucose metabolism in healthy adults.
Date of disclosure of the study information 2017/10/07
Last modified on 2017/11/21

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Basic information
Public title A clinical study on the effects of beverage containing probiotics on glucose metabolism in healthy adults.
Acronym Effects of beverage containing probiotics on glucose metabolism.
Scientific Title A clinical study on the effects of beverage containing probiotics on glucose metabolism in healthy adults.
Scientific Title:Acronym Effects of beverage containing probiotics on glucose metabolism.
Region
Japan

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

Objectives
Narrative objectives1 To evaluate the effects of a beverage containing probiotics on glucose metabolism.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Plasma glucose level and area under the curve of plasma glucose during 75 g oral glucose tolerance test.
Key secondary outcomes Insulin resistance, fasting blood glucose level, Hemoglobin A1c (HbA1c), blood short chain fatty acid, fecal bifidobacteria.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of 100 g of beverage containing probiotics daily for 12 weeks.
Interventions/Control_2 Ingestion of 100 g of beverage without probiotics daily for 12 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
65 years-old >
Gender Male and Female
Key inclusion criteria 1. Healthy men or women between the age of 20 and 64 years.
2. A fasting plasma glucose level of 110 mg/dL to 125 mg/dL and/or 2 hour plasma glucose level during OGTT of 140 mg/dL to 199 mg/dL.
3. Subjects giving written informed consent.
Key exclusion criteria 1. Subjects routinely taking medicine as well as administration of medication which may influence blood glucose level.
2. Subjects routinely taking health food or supplement which may influence glucose metabolism.
3. Subjects with diabetes.
4. Subjects who are under medication or have serious diseases.
5. Subjects who have surgical history such as gastrointestinal disease.
6. Subject who regularly undertakes medication or treatment that affects bowel motion (such as: antibiotics, antiflatulents, laxatives, antidiarrheal drug).
7. Subjects who regularly consume functional food/nutraceuticals, health supplements (such as: lactic acid bacteria, bifidobacteria, oligosaccharides, dietary fiber) antiflatulents and/or laxatives in common use.
8. Subjects who habitually consume fermented foods during the study period.
9. Subjects who are under treatment or have a history of drug/alcohol dependence.
10. Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating.
11. Subjects with allergic to test products used in the study.
12. Subjects who participate in other clinical or plan to other clinical trials during this study period.
13. Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL 03-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Co., Ltd
Division name Sales department
Zip code
Address 1-9-7, Shibaura, Minato-ku, Tokyo, Japan
TEL 03-3452-7733
Homepage URL
Email yoshikawa@kso.co.jp

Sponsor
Institute KSO Co., Ltd
Institute
Department

Funding Source
Organization Ezaki Glico 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
Address
Tel
Email

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 日本橋循環器科クリニック(東京)/Nihonbashi Cardiology Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information
2017 Year 10 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
1.Intake of beverage containing probiotics reduced 2 hour plasma glucose level during OGTT at 8 weeks.
2.Intake of beverage containing probiotics improved insulin resistance.
3.Intake of beverage containing probiotics increased fecal bifidobacteria.
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
2016 Year 08 Month 05 Day
Date of IRB
Anticipated trial start date
2016 Year 08 Month 06 Day
Last follow-up date
2016 Year 12 Month 04 Day
Date of closure to data entry
2017 Year 01 Month 23 Day
Date trial data considered complete
2017 Year 03 Month 16 Day
Date analysis concluded
2017 Year 03 Month 30 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 04 Day
Last modified on
2017 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027027

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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