UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033428
Receipt No. R000038119
Scientific Title Preliminary study on the effect of functional food on body fat in human
Date of disclosure of the study information 2018/07/24
Last modified on 2018/07/18

* 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 Preliminary study on the effect of functional food on body fat in human
Acronym Preliminary study on the effect of functional food on body fat in human
Scientific Title Preliminary study on the effect of functional food on body fat in human
Scientific Title:Acronym Preliminary study on the effect of functional food on body fat in human
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect and safety of functional food on body fat in human.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Abdominal total fat area
Key secondary outcomes

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Functional food(low dose), 12 weeks
Interventions/Control_2 Functional food(high dose), 12 weeks
Interventions/Control_3 Food without functional food, 12 weeks
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

Not applicable
Gender Male and Female
Key inclusion criteria 1) Subject who is 20 years of age or older.
2) Subject, 23 kg/m2 <= BMI < 30 kg/m2.
3) Subject who is able to give written informed consent before the study.
Key exclusion criteria (1)Subjects who are with treatment.
(2)Subjects who are with history of gastrointestinal surgery.
(3)Subjects who are attending other studies or attended other studies within the past 4 weeks.
(4)Subjects who are;
(a)With present heart disorder, liver disorder, or kidney disorder,
(b)With history of cardiac disorder,
(c)With diabetes mellitus, or
(d)With allergy to the study foods.
(5)Subjects who are not negative for syphilis, HBs antigen, HCV antibody or HIV antigen/antibody test.
(6)Subjects who are deemed to be unsuitable by the investigator.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuji Nonaka
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0587
Email Yuji_Nonaka@suntory.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kenji Yamamoto
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Division name Research Institute
Zip code
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-0594
Homepage URL
Email K_Yamamoto@suntory.co.jp

Sponsor
Institute SUNTORY GLOBAL INNOVATION CENTER LIMITED
Institute
Department

Funding Source
Organization SUNTORY GLOBAL INNOVATION CENTER LIMITED
Organization
Division
Category of Funding Organization Self funding
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
2018 Year 07 Month 24 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 Preinitiation
Date of protocol fixation
2018 Year 07 Month 11 Day
Date of IRB
Anticipated trial start date
2018 Year 07 Month 25 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
2018 Year 07 Month 18 Day
Last modified on
2018 Year 07 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038119

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.