UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018905 |
|---|---|
| Receipt number | R000021815 |
| Scientific Title | The double blinded, randomized placebo-controlled trial to evaluate the improvement effects of Oligonol ingestion on hidden obesity in healthy women. |
| Date of disclosure of the study information | 2015/09/04 |
| Last modified on | 2017/03/30 18:12:47 |
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Basic information
Public title
The double blinded, randomized placebo-controlled trial to evaluate the improvement effects of Oligonol ingestion on hidden obesity in healthy women.
Acronym
The improvement effects of Oligonolingestion on hidden obesity
Scientific Title
The double blinded, randomized placebo-controlled trial to evaluate the improvement effects of Oligonol ingestion on hidden obesity in healthy women.
Scientific Title:Acronym
The improvement effects of Oligonolingestion on hidden obesity
Region
| Japan |
Condition
Condition
Hidden obesity of healthy subjects
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the improvement effect of Oligonol ingestion (100 mg/day) on hidden obesity in healthy female university students.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Body compositions including body fat percentage, body weight and BMI: 0, 4, 8, 12 weeks
Key secondary outcomes
Blood lipid- and glucose- related markers including triglyceride, cholesterol, glucose, HbA1c, adiponectine,leptine etc.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Active: Oligonol 100 mg/day (1 capsule/day) for 12 weeks.
Interventions/Control_2
Placebo: dextrin (1 capsule/day) for 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
| 18 | years-old | <= |
Age-upper limit
| 25 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Person who was diagnosed as health by doctor
2. Aged 18-25
3. Person that informed consent was provided and agreed to participate in the study
Key exclusion criteria
1. Person having a disease
2. Person who takes medicine
3. Current smokers
4. Person having food allergy
5. Person who was diagnosed as an incompetent by doctor
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Taga |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
Address
2-3-1, Konodai, Ichikawa city, Chiba
TEL
047-371-1591
m-taga@wayo.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Taga |
Organization
Wayo Women's University
Division name
Department of Health and Nutrition
Zip code
Address
2-3-1, Konodai, Ichikawa city, Chiba
TEL
047-371-1591
Homepage URL
m-taga@wayo.ac.jp
Sponsor or person
Institute
Wayo 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
| 2015 | Year | 09 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2015 | Year | 07 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | Month | 28 | 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
| 2015 | Year | 09 | Month | 03 | Day |
Last modified on
| 2017 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021815
