UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023480 |
|---|---|
| Receipt number | 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 19:23:39 |
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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
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
yoshikawa@kso.co.jp
Sponsor or person
Institute
KSO Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027027
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| Registered date | File name |
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