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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033364
Receipt No. 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

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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
Email 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
Email info@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
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 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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038029

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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