UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study on the effects of beverage containing probiotics on glucose metabolism in healthy adults.
Title of the study (Brief title)	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	Yoshitaka Iwama
Organization	Nihonbashi Cardiology Clinic
Division name	Director
Address	13-4, Nihonbashikodenmacho, Chuo-ku, Tokyo, Japan
TEL	03-5641-4133
Email	yiwama@well-sleep.jp

Public contact
Name of contact person	Eiji Yoshikawa
Organization	KSO Co., Ltd
Division name	Sales department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 05 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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