UMIN-CTR Clinical Trial

Public title

Study for confirming anti-obesity effect by ingesting test food (preliminary examination)

Acronym

Study for confirming anti-obesity effect by ingesting test food (preliminary examination)

Scientific Title

Study for confirming anti-obesity effect by ingesting test food (preliminary examination)

Scientific Title:Acronym

Study for confirming anti-obesity effect by ingesting test food (preliminary examination)

Region

Japan

Condition

Healthy male

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Confirmation of anti-obesity effect by ingesting test food

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Body weight
BMI
Body fat percentage
Visceral fat area

Key secondary outcomes

Amount of liver fat
Fatty liver
Waist circumference
Incidence of adverse events and/or side effects

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

Intake test foods for 12 weeks.

Interventions/Control_2

Intake control foods for 12 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

59

years-old

>=

Gender

Male

Key inclusion criteria

(1) Males aged 20 to 59 when informed consent.
(2) Subjects whose body mass index (BMI) is included between 23.0 kg/m^2 to less than 30.0 kg/m^2.
(3) Subjects giving written informed consent.

Key exclusion criteria

(1) Subjects who are given continuous treatment by taking medicines.
(2) Subjects who having Food for Specified Health Uses (FOSHU), functional food, health food and/or supplements having a possibility of affecting test results.
(3) Subjects who have weak digestive organ. Especially subjects who may feel discomfort for example stomach astigmatism after intake of drinks containing tannin like strong green tea, black tea and coffee.
(4) Subjects who are severe anemia, or who have been diagnosed with severe anemia by the doctor
(5) Subjects who have previous and/or current medical history of serious disease (e.g., heart, liver, kidney, digestive organ).
(6) Subjects who excessive alcohol intake.
(7) Subjects who have extremely irregular dining habits, and subjects who have midnight work or irregular shift work.
(8) Subjects who have previous medical history of drug and/or food allergy.
(9) Subjects who are participating the other clinical tests. Subjects who participated within 4-weeks prior to the current study and/or who plan to participate the other clinical tests.
(10) Subjects who donated over 200mL blood and/or blood components within the last one month to the current study.
(11) Subjects who donated over 400mL blood and/or blood components within the last three month to the current study.
(12) Subjects who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last twelve month are adding to the planned sampling amounts of this study.
(13) Others who have been determined ineligible by principal investigator or sub-investigator.

Target sample size

40

Name of lead principal investigator

1st name	Suguru
Middle name
Last name	Fujiwara

Organization

CPCC CO., LTD.

Division name

Division of Clinical Research

Zip code

101-0047

Address

4F Sanwa-Uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Email

cpcc-contact@cpcc.co.jp

Name of contact person

1st name	Masanori
Middle name
Last name	Numa

Organization

CPCC CO., LTD.

Division name

Plan Sales Department

Zip code

101-0047

Address

4F Sanwa-Uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

TEL

03-5297-3112

Homepage URL

Email

cpcc-contact@cpcc.co.jp

Institute

CPCC CO., LTD.

Institute

Department

Personal name

Organization

NAGAOKA CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board of Chiyoda Paramedical Care Clinic

Address

2F Sanwa-Uchikanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN

Tel

03-5297-5548

Email

IRB@cpcc.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

07

Month

22

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

07

Month

19

Day

Date of IRB

2019

Year

07

Month

19

Day

Anticipated trial start date

2019

Year

07

Month

22

Day

Last follow-up date

2019

Year

11

Month

21

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2019

Year

07

Month

19

Day

Last modified on

2020

Year

07

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042668