UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032555 |
|---|---|
| Receipt number | R000037130 |
| Scientific Title | A clinical study to evaluate the anti-obesity effect of capsules containing noni fruit powder. |
| Date of disclosure of the study information | 2019/08/31 |
| Last modified on | 2023/05/15 12:33:00 |
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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
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-obesity effect of intake capsules containing noni fruit powder for 12 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, body fat percentage, total fat area
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake of capsules containing noni fruit powder for 12 weeks.
Interventions/Control_2
Intake of capsules non-containing noni fruit powder (placebo) 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
| 20 | years-old | <= |
Age-upper limit
| 55 | years-old | > |
Gender
Male and Female
Key inclusion criteria
The subject who meets all the conditions in a screening test
1) Subject whose age of 20 years or more and less than 55 years at the time of informed consent.
2) Subject whose BMI is 25 kg/m2 or more and less than 30 kg/m2.
3) Subject who is received sufficient explanation about purpose and content of this exam and have the capacity to consent and voluntarily write participation agreement in this examination voluntarily participate after understanding well.
Key exclusion criteria
1) Subject who has a mental disease such as depression, schizophrenia, epilepsy and bulimia nervosa.
2) Subject who has allergic disease, cardiovascular, respiratory, thyroid gland malfunction, diabetes, heart disease, heart disease, gout or sleep disorder.
3) Subject who takes regularly medicinal drugs or medicines 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 that influence the evaluation of the effects of the test food.
6) Female subject who is pregnant or may be pregnant during the study.
7) Female subject who is in the lactation during the study.
8) Subject who took blood samples 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 participating in other clinical trials or planning to participate in other clinical trials during the examination period.
10) Subject deemed unsuitable by the investigator.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaya Morimoto |
Organization
ASKA Pharmaceutical. Co., Ltd.
Division name
Healthcare Business Unit
Zip code
Address
2-5-1, Shibaura, Minato-ku, Tokyo
TEL
03-5484-8307
morimoto-ms@aska-pharma.co.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
sugino@soiken.com
Sponsor or person
Institute
Soiken Inc.
Institute
Department
Personal name
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
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 | 08 | Month | 31 | 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
| 2018 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 09 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 11 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037130
