UMIN-CTR Clinical Trial

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

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018905
Receipt No. 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

* 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 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
Email 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
Email m-taga@wayo.ac.jp

Sponsor
Institute Wayo Women's University
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021815

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.