UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034075
Receipt number R000038784
Scientific Title Effects of a Test Food for Reducing Body Fat.
Date of disclosure of the study information 2018/09/10
Last modified on 2019/03/12 09:22:54

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Effects of a Test Food for Reducing Body Fat.

Acronym

Effects of a Test Food for Reducing Body Fat.

Scientific Title

Effects of a Test Food for Reducing Body Fat.

Scientific Title:Acronym

Effects of a Test Food for Reducing Body Fat.

Region

Japan


Condition

Condition

N/A (healthy adults)

Classification by specialty

Not applicable Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of a test food for reducing body fat.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

[1]Abdominal visceral fat mass (Week 0, Week 12); BMI (Week 0, Week 4, Week 8, Week 12)

Key secondary outcomes

*Secondary indexes
[1]Weight, body fat percentage, BMI (Week 0, Week 4, Week 8, Week 12)
[2]Waist girth, hip girth / waist-hip ratio (Week 0, Week 8, Week 12)

*Safety
[1]Blood pressure, pulsation (Week 0, Week 4, Week 8, Week 12)
[2]Hematologic test (Week 0, Week 4, Week 8, Week 12)
[3]Blood biochemical test (Week 0, Week 4, Week 8, Week 12)
[4]Urine analysis (Week 0, Week 4, Week 8, Week 12)
[5]Doctor's questions (Week 0, Week 4, Week 8, Week 12)

*Other indexes
[1]Subject's diary (From the first day of ingestion of a test material to the last day of the test)
[2]Dietary survey (3 days prior to each inspection date)


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

Treatment

Type of intervention

Food

Interventions/Control_1

Oral intake of the test food (2 sticks in a day; 12 weeks).

Interventions/Control_2

Oral intake of the placebo food (2 sticks in a day; 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



Eligibility

Age-lower limit

35 years-old <=

Age-upper limit

65 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Healthy Japanese males and females aged 35-65 years.
[2]Individuals whose BMI is over 25-30.
[3]Individuals whose written informed consent has been obtained.
[4]Individuals who can visit an inspection facility and be inspected in designated days.
[5]Individuals judged appropriate for the study by the principal.

Key exclusion criteria

[1]Individuals whose BMI is over 25.0 and abdominal visceral fat mass measured with FatScan is over 100 cm2 (individuals who are visceral fat type obesity defined in Guidelines for the Management of Obesity Disease).
[2]Individuals using medical products.
[3]Individuals who are patient or have a history of psychiatric disease, high blood pressure, diabetes, and hyperlipidemia.
[4]Individuals who used or applied a drug for treatment of disease in the past 1 month.
[5]Individuals who have a history of serious hepatopathy, kidney damage, heart disease, hematological and blood disease.
[6]Individuals who are a patient or have a history of or endocrine disease.
[7]Individuals who have gained or lost 2 kg of body weight in the past 3 months.
[8]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months.
[9]Individuals with serious anemia.
[10]Individuals who are sensitive to test product or other foods, and medical products.
[11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[12]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[13]Individuals having a habit to intake a food containing the component of the test food.
[14]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months.
[15]Individuals who are or are possibly, or are lactating.
[16]Individuals who participated in other clinical studies in the past 3 months.
[17]Individuals judged inappropriate for the study by the principal.

Target sample size

46


Research contact person

Name of lead principal investigator

1st name Mamoru
Middle name
Last name Oki

Organization

Seishukai Medical Corporation Seishukai Hospital

Division name

Head

Zip code

111-0036

Address

3-18-5 Matsugaya Taito-ku Tokyo 111-0036, JAPAN

TEL

+81-3-3847-8866

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name Ryoma
Middle name
Last name Shimizu

Organization

TES Holdings Co., Ltd

Division name

Administrative Department of Clinical Trials

Zip code

110-0015

Address

6F Kairaku Building 2-7-5 Higashiueno Taito-ku Tokyo 110-0015, JAPAN

TEL

+81-3-601-8480

Homepage URL


Email

r.shimizu@tes-h.co.jp


Sponsor or person

Institute

MISUZU-CO Co.,Ltd.

Institute

Department

Personal name



Funding Source

Organization

MISUZU 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

The Ethics Committee of the Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Address

1-20-11 Ueno Taito-ku Tokyo 110-0005, JAPAN

Tel

+81-3-5816-0711

Email

i.takahashi@tes-h.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

2018 Year 09 Month 10 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 08 Month 30 Day

Date of IRB

2018 Year 08 Month 28 Day

Anticipated trial start date

2018 Year 09 Month 12 Day

Last follow-up date

2018 Year 12 Month 10 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 10 Day

Last modified on

2019 Year 03 Month 12 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038784


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name