UMIN-CTR Clinical Trial

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