UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037914 |
|---|---|
| Receipt number | 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 13:24:12 |
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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
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
k.wasaki@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
Hitachi Omika Hospital
Address
2-22-30,omika-cho,hitachi-shi,Ibaraki
Tel
029-232-8788
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043215
