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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030607
Receipt No. R000034784
Scientific Title A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder
Date of disclosure of the study information 2019/02/17
Last modified on 2017/12/19

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Basic information
Public title A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder
Acronym A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder
Scientific Title A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder
Scientific Title:Acronym A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder
Region
Japan

Condition
Condition None
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the anti-obesity effect of intakeof capsules containing noni fruit powder for 4 weeks
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Body weight, BMI
Key secondary outcomes Waist circumference, Visceral fat area, Total fat percentage, Total fat area

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake of capsules containing noni fruit powder for 4 weeks
Interventions/Control_2
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
55 years-old >
Gender Male and Female
Key inclusion criteria 1) Subject whose age of 20 years or more and less than 55 years at informed consent
2) Subject whose BMI is 25 kg/m2 or more and less than 30 kg/m2
3) Subject who weighs less than 88 kg
4) Subject having a briefing of the content of the present study, fully understanding and agreeing to its objective and being able to personally sign a written informed consent
Key exclusion criteria 1) Subject who has a mental disease such as depression, schizophrenia, epilepsy or bulimia nervosa
2) Subject who has allergic disease, cardiovascular, respiratory, thyroid gland malfunction, diabetes, heart disease, brain disease, gout or sleep disorder
3) Subject who takes regularly medicinal drugs or pharmaceuticals having an effect on the weight
4) Subject who has the possibility of developing allergic symptoms by the test food (noni allergy)
5) Subject who has a snacking habit
6) Female subject who is pregnant or may be pregnant
7) Female subject who is in lactating
8) Subject who has blood sample of 200 ml or more within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood)
9) Subject who participated in other clinical trials within the past 4 months or currently participates in other clinical trials or plans to participate in other clinical trials during the examination period
10) Subject deemed unsuitable by the investigator
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Fukuda
Organization Fukuda Clinic
Division name Director
Zip code
Address Shin-Osaka Brick Building 2F, 1-6-1, Miyahara, Yodogawa-ku, Osaka
TEL 06-6398-0203
Email fukuda@drmog.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomohiro Sugino
Organization Soiken Inc.
Division name R&D Division
Zip code
Address Senri Life Science Center 13F, 1-4-2, Shinsenri-higashimachi, Toyonaka, Osaka
TEL 06-6871-8888
Homepage URL
Email sugino@soiken.com

Sponsor
Institute Soiken Inc.
Institute
Department

Funding Source
Organization ASKA Pharmaceutical 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
2019 Year 02 Month 17 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
2017 Year 09 Month 16 Day
Date of IRB
Anticipated trial start date
2018 Year 01 Month 06 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 12 Month 28 Day
Last modified on
2017 Year 12 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034784

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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