UMIN-CTR Clinical Trial

Basic information
Public title	A pilot study for the effect of food containing Lactic acid bacteria in subjects with awareness of overeating and postprandial hyperglycemia.
Acronym	A pilot study for the effect of food containing Lactic acid bacteria.
Scientific Title	A pilot study for the effect of food containing Lactic acid bacteria in subjects with awareness of overeating and postprandial hyperglycemia.
Scientific Title:Acronym	A pilot study for the effect of food containing Lactic acid bacteria.
Region	Japan

Condition
Condition	None (Healthy adult)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect on appetite and blood glucose of Lactic acid bacteria-containing foods intake for 8 consecutive weeks
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Questionnaire on feeling of fullness and appetite (SNAQ-JE, VAS-questionnaire) at 4 and 8 week ingestion
Key secondary outcomes	(Blood glucose AUC, insulin AUC, GLP-1 AUC), blood glucose, insulin, GLP-1 peak value (blood glucose Cmax, blood glucose level) under the 75 g OGTT and each change amount, concentration time curve, Insulin Cmax, GLP-1 Cmax) at 4 and 8 week ingestion

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of Lactic acid bacteria containing food for 8 consecutive weeks
Interventions/Control_2
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	69 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Male and female aged from 20 to 69 (2) Subjects who are aware of overeating tendencies, but who were judged healthy by the investigator (3) Subjects with BMI greater than 25.0 and less than 30.0 kg / m^2 (4) Subjects with a fasting blood glucose level greater than 100 or more and 125 mg / dL or less or 75 g OGTT 120 minutes value of greater than 140 or more and 199 mg / dL or less
Key exclusion criteria	(1) Subjects who continuously take medicine and health foods related to rich in lactic acid bacteria or related to glycometabolism and appetite (2) Subjects who have or has medical history serious illness such as diabetes, liver disease, kidney disease, heart disease (3) Subjects who has chronic illness or have medical history of serious illness for medication (4) Subjects who have possibilities for emerging allergy onset related to the study (5) Subjects who was given or donated 200 ml or 400 ml whole blood within three months before pre-inspection (6) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection (7) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (8) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (10) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size	10

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Soichi Tanabe
Organization	NISSIN FOODS HOLDINGS CO., LTD. R&D Platform NISSIN Global Innovation Center
Division name	Health Science Research Office
Zip code
Address	2100, Tobukimachi, Hachioji, Tokyo
TEL	042-696-7685
Email	soichi.tanabe@nissin.com

Public contact
1st name of contact person	1st name Middle name Last name Kotoha Isobe
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	k.isobe@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd.
Institute
Department

Funding Source
Organization	NISSIN FOODS HOLDINGS 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
Email

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	2018 Year 09 Month 28 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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	2018 Year 09 Month 27 Day
Date of IRB	2018 Year 09 Month 27 Day
Anticipated trial start date	2018 Year 09 Month 29 Day
Last follow-up date	2018 Year 12 Month 20 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 09 Month 28 Day
Last modified on	2019 Year 03 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039115