UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030834 |
|---|---|
| Receipt number | R000035194 |
| Scientific Title | Evaluation of anti-obesity effect of test food |
| Date of disclosure of the study information | 2018/07/10 |
| Last modified on | 2018/07/09 17:28:55 |
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Basic information
Public title
Evaluation of anti-obesity effect of test food
Acronym
Evaluation of anti-obesity effect of test food
Scientific Title
Evaluation of anti-obesity effect of test food
Scientific Title:Acronym
Evaluation of anti-obesity effect of test food
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the anti-obesity effect of daily intake of seaweed (Ascophyllum nodosum) extract-containing food.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Body weight
2) BMI
3) Abdominal circumference
4) Abdominal CT
5) Body fat percentage
(0, 12 week)
Key secondary outcomes
1) Hematological tests
2) Blood biochemistry tests
(0, 12 week)
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
Duration: 12 weeks
Test foods: Seaweed (Ascophyllum nodosum) extract-containing tablet
One tablet per day
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
| Not applicable |
Gender
Male
Key inclusion criteria
1) Men of Japanese
2) 25<=BMI<30
Key exclusion criteria
1) Currently under the treatment with medication, diet or exercise therapy.
2) At least one previous medical history of hepatic disorder, renal disorder, endocrine system diseases, cardiovascular disorder, gastrointestinal disorder, pulmonary disease, hematological disorder, or metabolic disorder.
3) Currently taking functional foods or supplements which would affect blood glucose level or body fat percentage.
4) Those who are allergic to medicines or foods.
5) Those who working irregularly such as working on night shift.
6) Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial.
7) Others considered as inappropriate for the study by the physician.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiro Uemura |
Organization
MEDIPHARMA CORP.
Division name
Clinical development support division
Zip code
Address
9F RBM Hamamatsucho Bldg., 1-27-12, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan.
TEL
03-5733-0441
naohiro@medipharma.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kana Arai |
Organization
MEDIPHARMA CORP.
Division name
Clinical development support division, Site administration office
Zip code
Address
9F RBM Hamamatsucho Bldg., 1-27-12, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan.
TEL
03-5733-0441
Homepage URL
arai@medipharma.co.jp
Sponsor or person
Institute
MEDIPHARMA CORP.
Institute
Department
Personal name
Funding Source
Organization
RIKEN VITAMIN 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
医療法人社団桜緑会 日本橋さくらクリニック (東京都)
Ouryoku-kai Medical Corporation, Nihonbashi Sakura Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 10 | 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 | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 17 | 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 | 01 | Month | 16 | Day |
Last modified on
| 2018 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035194
