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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029053
Receipt No. R000033231
Scientific Title Study on body fat reducing effect of dietary supplement -A randomized, double blind, placebo-controlled, parallel group study-
Date of disclosure of the study information 2017/09/08
Last modified on 2017/09/08

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Basic information
Public title Study on body fat reducing effect of dietary supplement -A randomized, double blind, placebo-controlled, parallel group study-
Acronym Study on body fat reducing effect of dietary supplement
Scientific Title Study on body fat reducing effect of dietary supplement -A randomized, double blind, placebo-controlled, parallel group study-
Scientific Title:Acronym Study on body fat reducing effect of dietary supplement
Region
Asia(except Japan)

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

Objectives
Narrative objectives1 This study aims to evaluate the effect of the dietary supplement on body fat of subject aged 40 to 64 years with slightly high body mass index (BMI: 23 kg/m2 to less than 30 kg/m2).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Abdominal fat area
Key secondary outcomes Body weight, BMI, body fat percentage

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Intake of dietary supplement for 12 consecutive weeks
Interventions/Control_2 Intake of placebo for 12 consecutive 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
40 years-old <=
Age-upper limit
65 years-old >
Gender Female
Key inclusion criteria 1)Vietnamese women between 40 and 65 years old at the time of obtaining informed consent.
2)BMI between 23 and 30kg/m2.
3)Waist circumference of at least 80cm.
Key exclusion criteria 1)The candidate is currently undergoing drug or exercise therapy.
2)The candidate currently has, or has a history of, diabetes, liver disease, kidney disease, heart disease, any disease that affects corticosteroid secretion, and/or any other metabolic disease.
3)There are concerns about the potential for the study foods to induce allergic symptoms in the candidate.
4)The candidate is pregnant, or intends to become pregnant or to breastfeed during the study period.
5)The candidate generally or routinely takes any medication that affects body fat and/or lipid metabolism, including over-the-counter drugs, quasi-drugs, and health foods.
6)The candidate is currently dieting with the aim of reducing body weight.
7)The candidate has participated in any other clinical study within the past 1month.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Bui Thi Nhung
Organization National Institute of Nutrition
Division name -
Zip code
Address 48B-Tang Bat Ho, Hanoi-Vietnam
TEL +84-43971-7090
Email nhungvnnin@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Yoshiki Shimizu
Organization FANCL Corporataion
Division name Research Institute
Zip code
Address 12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa 244-0806, Japan
TEL 045-820-3755
Homepage URL
Email shimizu_yoshiki@fancl.co.jp

Sponsor
Institute FANCL Corporation
Institute
Department

Funding Source
Organization FANCL Corporation
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
2017 Year 09 Month 08 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 02 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 23 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
2017 Year 09 Month 08 Day
Last modified on
2017 Year 09 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033231

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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