UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034311 |
|---|---|
| Receipt number | R000039115 |
| Scientific Title | A pilot study for the effect of food containing Lactic acid bacteria in subjects with awareness of overeating and postprandial hyperglycemia. |
| Date of disclosure of the study information | 2018/09/28 |
| Last modified on | 2019/03/19 14:20:00 |
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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
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
soichi.tanabe@nissin.com
Public contact
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
k.isobe@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039115
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
