UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031293 |
|---|---|
| Receipt number | R000033465 |
| Scientific Title | Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the effect of Oligonol on the reduction of body weight and body fat for healthy subjects. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2018/02/14 09:00:07 |
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Basic information
Public title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the effect of Oligonol on the reduction of body weight and body fat for healthy subjects.
Acronym
Clinical study for the evaluation of ameliorative effects of Oligonol on body weight and body fat.
Scientific Title
Randomized, double-blind, placebo-controlled parallel-group comparative study to investigate the effect of Oligonol on the reduction of body weight and body fat for healthy subjects.
Scientific Title:Acronym
Clinical study for the evaluation of ameliorative effects of Oligonol on body weight and body fat.
Region
| Japan |
Condition
Condition
Healyhy subjects whose BMI is 23-30
Classification by specialty
| Nursing | Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effect of Oligonol ingestion on body weight and body fat.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Body weight, Body fat mass, Body fat percentage, BMI
Key secondary outcomes
BDHQ, nutrient intake
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
The subjects take the Oligonol during two months
Interventions/Control_2
The subjects take the placebo during two months.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Aged 20-60
(2) MBI 23-30
(3) Person who is able to come the test place at the days of measurement
(4) Person who has no diseases relating obesity
(5) Person who was diagnosed as health by doctor
(6) Person who can hold back excessive eating and drinking
Key exclusion criteria
(1) Person ingesting the drugs, supplements and health food products relating lipid metabolism
(2) Patients with chronic disease and medicated
(3) Heavy smoker (>21 pieces/day)
(4) Heavy drunker(>20 g/day of alcohol)
(5) Person who has the allergy with food and drug, especially, lychee, tea, gelatin, pork)
(6) Pregnancy, willing the be pregnant, or breast-feeding.
(7) Person who cannot stop taking excess polyphenolic ingredient such as tea and green tea
(8) Person who is judged as unfit for the subject by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takayuki Ikeda |
Organization
Fuji Women's University
Division name
Faculty of Human Life Sciences
Zip code
Address
Hanakawa Minami 4jo-5, Ishikari-shi, Hokkaido, Japan
TEL
0133-74-7389
ikeda@fujijoshi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takayuki Ikeda |
Organization
Fuji Women's University
Division name
Faculty of Human Life Sciences
Zip code
Address
Hanakawa Minami 4jo-5, Ishikari-shi, Hokkaido, Japan
TEL
0133-74-7389
Homepage URL
ikeda@fujijoshi.ac.jp
Sponsor or person
Institute
Fuji Women's University
Institute
Department
Personal name
Funding Source
Organization
Amino Up Chemical 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
Address
Tel
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 | 05 | Month | 01 | 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
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 10 | Month | 07 | 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 | 02 | Month | 14 | Day |
Last modified on
| 2018 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033465
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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