UMIN-CTR Clinical Trial

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

Healthy adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

TTC Co., Ltd

Institute

Department

Personal name

Organization

NISSIN FOODS HOLDINGS CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

30

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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