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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030834
Receipt No. R000035194
Official scientific title of the study Evaluation of anti-obesity effect of test food
Date of disclosure of the study information 2018/07/10
Last modified on 2018/07/09

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Basic information
Official scientific title of the study Evaluation of anti-obesity effect of test food
Title of the study (Brief title) 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 Naohiro Uemura
Organization MEDIPHARMA CORP.
Division name Clinical development support division
Address 9F RBM Hamamatsucho Bldg., 1-27-12, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan.
TEL 03-5733-0441
Email naohiro@medipharma.co.jp

Public contact
Name of contact person Kana Arai
Organization MEDIPHARMA CORP.
Division name Clinical development support division, Site administration office
Address 9F RBM Hamamatsucho Bldg., 1-27-12, Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan.
TEL 03-5733-0441
Homepage URL
Email arai@medipharma.co.jp

Sponsor
Institute MEDIPHARMA CORP.
Institute
Department

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)

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

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 12 Month 18 Day
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

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035194

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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