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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000034075
Receipt No. 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

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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
Institute MISUZU-CO Co.,Ltd.
Institute
Department

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
URL(English) https://upload.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


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