UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033364 |
|---|---|
| Receipt number | R000038029 |
| Scientific Title | Verification of improvement effect for insulin sensitivity |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/12/30 10:02:21 |
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Basic information
Public title
Verification of improvement effect for insulin sensitivity
Acronym
Verification of improvement effect for insulin sensitivity
Scientific Title
Verification of improvement effect for insulin sensitivity
Scientific Title:Acronym
Verification of improvement effect for insulin sensitivity
Region
| Japan |
Condition
Condition
No applicable
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the influence for insulin sensitivity in the case of long term (12 weeks) consumption on daily life.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Insulin sensitivity (Matsuda-index)
Key secondary outcomes
* Insulin resistance (HOMA-IR)
* Fasting blood glucose level
* AUC of blood glucose
* The number of Bifidobacterium in feces
* Glycated albumin
* BAP
* d-RPMs
* 8-OHdG
* Accumulation level of advanced glycation end products
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
In consecutive 12 weeks, intake one test food (100g, a beverage containing 1*10^10 cfu of Bifidobacterium animalis subsp. lactis GCL2505, 2.0g of inulin and 9.0mg of paprika xanthophyll as an active ingredient) a day. Visit clinic at 0, 8 and 12 weeks after start of test food consumption, receive the tests in each visit.
Interventions/Control_2
In consecutive 12 weeks, intake one control food (100g, a beverage not containing active ingredient) a day. Visit clinic at 0, 8 and 12 weeks after start of control food consumption, receive the tests in each visit.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Males and females aged 20 to 59 years old.
(2) Subjects their blood glucose level are in normal or border area (subjects their fasting blood glucose are less than 126 mg/dL or their blood glucose level of 120 min after OGTT are less than 200 mg/dL).
(3) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1) Subjects who didn't undergo abdominal surgical operation within 6 month before test start.
2) Subjects who are being treated medication at present.
3) Subjects who have allergy to test food.
4) Smokers
5) Subjects their living together has plane to participate to same clinical test.
6) Subjects who plan big change of lifestyle during test period.
7) Subjects with tendency of chronic diarrhea.
8) Subjects who have inappropriate medical history such as significant functional impairment in liver, kidney and/or heart-blood system.
9) Subjects who suspected chronic or serious infectious disease.
10) Females who are pregnant, lactating or possibility of pregnancy.
11) Subjects who have participated the other clinical test within 3 month before test start.
12) Subjects who can't refrain from consumption of lactic bacteria, bifidobacterium, oligosaccharide and/or dietary fiber rich foods during test period, of fermented foods such as the natto, pickles and/or cheese.
13) Subjects who regularly consume the supplement containing similar ingredient of Xanthophyll, a vegetable juice and/or a tomato juice more than 5 days a week. Subjects who can't refrain from consumption of the supplement and/or the juice mentioned above, of the wenzhou mandarin orange and/or that juice during test period.
14) Subjects who donated over 200mL blood and/or blood components within a month.
15) Males who donated over 400mL blood within the last 3 months.
16) Females who donated over 400mL blood within the last 4 months.
17) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
18) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
19) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
info@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Sanwauchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
info@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
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
Institutional Review Bord of Chiyoda Paramedical Care Clinic
Address
2F Uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
Tel
03-5297-5548
IRB@cpcc.co.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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 31 | Day |
Related information
URL releasing protocol
No preparation
Publication of results
Published
Result
URL related to results and publications
No preparation
Number of participants that the trial has enrolled
120
Results
A significant increase in total bifidobacterial count was observed in the test-food (TF) group compared to the control. But, the control subjects who had a significant increase in daily steps showed improvements in glucose metabolism-related markers.
In the TF group, a significant positive correlation between the increased number of total bifidobacterial count and the change in Matsuda-index, suggested an insulin-sensitivity recovery. This is consistent with the prior results (UMIN000023480).
Results date posted
| 2020 | Year | 04 | Month | 03 | Day |
Results Delayed
Results Delay Reason
Undisclosed
Date of the first journal publication of results
Baseline Characteristics
Background of the Full Analysis Set
Test food group
Gender : Male 26, Female 33
Age : 48.8 +/- 9.3
Height: 163.61 +/- 9.66
Weight : 64.23 +/- 14.08
BMI: 23.85 +/- 3.93
Control food group
Gender : Male 23, Female 33
Age : 48.7 +/- 8.9
Height: 163.08 +/- 7.97
Weight : 64.41 +/- 11.22
BMI: 24.15 +/- 3.39
Participant flow
Number of Screening : 1320
Number of Intention To Treat : 120
Number of Full Analysis Set: 115
Number of Per Protocol Set: 97
Adverse events
All of the adverse events observed in this study were not causally related to the test food, as determined by the clinical investigators, and no serious or severe adverse events were observed.
Outcome measures
Primary outcomes
Insulin sensitivity (Matsuda-index)
Secondary outcomes
* Insulin resistance (HOMA-IR)
* Fasting blood-glucose level
* AUC of blood glucose
* The number of Bifidobacteria in feces
* Glycated albumin
* BAP
* d-RPMs
* 8-OHdG
* Accumulation level of advanced glycation end products
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 11 | Day |
Last modified on
| 2020 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038029
