UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025076
Receipt number R000028777
Scientific Title Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat
Date of disclosure of the study information 2016/11/30
Last modified on 2017/03/12 14:13:30

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Basic information

Public title

Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat

Acronym

Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat

Scientific Title

Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat

Scientific Title:Acronym

Effects of a Drink Containing Citrus Fruit Juice for Reducing Body Fat

Region

Japan


Condition

Condition

N/A (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study examines effects of a drink containing citrus fruit juice 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 8, Week 12)

Key secondary outcomes

*Secondary outcomes
[1]Weight, body fat percentage, BMI (Week 0, Week 8, Week 12)
[2]Abdominal girth (Week 0, Week 8, Week 12)
[3]Blood test (adiponectin) (Week 0, Week 8, Week 12)
[4]Questionnaire survey (Week 0, Week 8, Week 12)

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

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


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 drink (200mL in a day; 12 weeks)

Interventions/Control_2

Oral intake of the placebo drink (200mL 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

20 years-old <=

Age-upper limit

75 years-old >

Gender

Male and Female

Key inclusion criteria

[1]Males and Females aged 20-74 years
[2]Individuals whose BMI is 23-29
[3]Individuals whose written informed consent has been obtained
[4]Individuals who can have an examination in a designated day
[5]Individuals judged appropriate for the study by the principal

Key exclusion criteria

[1]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 whose BMI is over 30.
[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 having a habit to intake foods containing components which are contained in the test product.
[12]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60mg/day).
[13]Individuals with possible changes of life style, such as conducting a long-term travel, during the test period.
[14]Individuals having a habit to intake a drink containing citrus juice.
[15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements containing hesperidin and nobiletin in the past 3 months or will ingest those foods during the test period.
[16]Individuals who have a habit to use drug claiming to reduce body fat in the past 3 months.
[17]Individuals who participated in other clinical studies in the past 3 months.
[18]Individuals judged inappropriate for the study by the principal.

Target sample size

48


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Atsuko Mori

Organization

Oriental Ueno Detection Center, General Incorporated Association Oriental Occupational Health Association Tokyo Branch

Division name

Head of center

Zip code


Address

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

TEL

+81-3-5816-0711

Email

info@tes-h.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Toshiyasu Tamura

Organization

TES Holdings Co., Ltd

Division name

Department of Development for Clinical Trials

Zip code


Address

6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN

TEL

+81-3-6801-8480

Homepage URL


Email

t.tamura@tes-h.co.jp


Sponsor or person

Institute

TES Holdings Co., Ltd

Institute

Department

Personal name



Funding Source

Organization

Okinawa TLO 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


Address


Tel


Email



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

2016 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

2016 Year 11 Month 05 Day

Date of IRB


Anticipated trial start date

2016 Year 12 Month 03 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 11 Month 30 Day

Last modified on

2017 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=R000028777


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name