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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000037914
Receipt No. R000043215
Scientific Title A study for the effect on appetite by food intake
Date of disclosure of the study information 2020/11/30
Last modified on 2020/11/27

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Basic information
Public title A study for the effect on appetite by food intake
Acronym A study for the effect on appetite by food intake
Scientific Title A study for the effect on appetite by food intake
Scientific Title:Acronym A study for the effect on appetite by food intake
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect on appetite of Lactic acid bacteria-containing foods intake for 4 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 apptite(SNAQ-JE,Visual analogue scale)at 4 week ingestion
Key secondary outcomes GLP-1 value,Bulimic Investigatory Test Edinburgh and dietary intake at 4 week

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 Ingestion of food containing Lactic acid bacteria for 4 consecutive weeks
Interventions/Control_2 Ingestion of placebo without Lactic acid bacteria for 4 consecutive 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
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 / m2
Key exclusion criteria (1) Subjects who continuously take
health foods related to rich in lactic acid bacteria for over once a week
(2) Subjects who continuously take
medicine and health foods related to
glycometabolism and appetite more than once a week
(3) Subjects who have the exercise habits more than twice a week
(4) Subjects who have meat skipping once and more a week
(5) Subjects with alcohol drinking habit more than three times a week
(6) Subjects who have the habit of taking foods high in lactic acid bacteria (fermented milk drink, yoghurt, kimuchi, and so on) and/or lactic acid bacteria preparations twice and more a week
(7) Subjects who are judged as bulimia in BITE
(8) Subjects who have or has medical history serious illness such as diabetes, liver disease, kidney disease, heart disease
(9) Subjects who has chronic illness
or have medical history of serious
illness for medication
(10) Subjects who have possibilities
for emerging allergy onset related to the study
(11) Subjects who was given or
donated 200 ml or 400 ml whole
blood within three months before pre-inspection
(12) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection
(13) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
(14) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
(15) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(16) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Soichi
Middle name
Last name Tanabe
Organization NISSIN FOODS HOLDINGS CO., LTD.
R&D Platform NISSIN Global Innovation Center
Division name Health Science Research Office
Zip code 192-0001
Address 2100, Tobukimachi, Hachioji, Tokyo
TEL 042-696-7685
Email soichi.tanabe@nissin.com

Public contact
Name of contact person
1st name Kunihiko
Middle name
Last name Wasaki
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code 150-0021
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email k.wasaki@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 Hitachi Omika Hospital
Address 2-22-30,omika-cho,hitachi-shi,Ibaraki
Tel 029-232-8788
Email Masaki.ohata@medical-art.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 11 Month 30 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
2019 Year 08 Month 30 Day
Date of IRB
2019 Year 08 Month 30 Day
Anticipated trial start date
2019 Year 09 Month 04 Day
Last follow-up date
2020 Year 02 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 09 Month 03 Day
Last modified on
2020 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043215

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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