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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031585
Receipt No. R000036055
Scientific Title The effects of food intake on insulin resistance and obesity
Date of disclosure of the study information 2018/03/20
Last modified on 2018/03/05

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Basic information
Public title The effects of food intake on insulin resistance and obesity
Acronym The effects of Onsen alga powder intake on insulin resistance and obesity
Scientific Title The effects of food intake on insulin resistance and obesity
Scientific Title:Acronym The effects of Onsen alga powder intake on insulin resistance and obesity
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 A placebo controlled double blind clinical trial to evaluate of the effects of Onsen alga on insulin resistance and obesity
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Not applicable
Key secondary outcomes Measurement of waist circumference, measurements of height and weight, measurement of vital sign, blood examination, findings and evaluations of a doctor, and a health state diary
From the baseline to Week 12

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Taking in 5 capsules of test sample after breakfast or in the morning every day for 12 weeks
Interventions/Control_2 Taking in 5 capsules of placebo sample after breakfast or in the morning every 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
20 years-old <=
Age-upper limit
64 years-old >=
Gender Male and Female
Key inclusion criteria 1) Age: from 20 to 64 years old
2) BMI: 25 or more but less than 30
Key exclusion criteria 1) Those who have more than 2.5 times of reference value of gamma-GT (gamma-GTP)
2) Those who have more than 2.5 times of reference value of AST (GOT)
3) Those who have more than 2.5 times of reference value of ALT (GPT)
4) Those who have more than 6.5 % of HbA1c value
5) Those who are taking a medicine that may influence test results. e.g. medicine that decreases the blood sugar level, etc.
6) Those who have been on a daily basis taken a health food(s) that may influence test results. e.g. health food that may decrease the blood sugar level, etc.
7) Women who are in pregnancy or may become pregnant, or are nursing
8) Those who are "Alcoholism"
9) Those who may have an allergy to the ingredient of the test sample
10) Participants in other clinical trial
11) Those who have a medical history of severe hepatic disorders, renal disorders, or cardiovascular disease
12) Those who have hepatitis or its previous history
13) Those who have severe anemia
14) Those who have hypertension
15) Those who have hyperlipidemia
16) Those who were judged inappropriate to join the study by doctor in charge
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Koikeda
Organization Shiba Palace Clinic
Division name Chair
Zip code
Address 6F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL +81-3-5408-1590
Email jimukyoku@mail.souken-r.com

Public contact
Name of contact person
1st name
Middle name
Last name Ko Masuda
Organization SOUKEN Co., Ltd
Division name Management Division
Zip code
Address 3F DaiwaA Hamamatucho Bld., 1-9-10 Hamamatsucho, Minato-ku, Tokyo, 105-0013, Japan
TEL +81-3-5408-1555
Homepage URL
Email k_masuda@mail.souken-r.com

Sponsor
Institute SOUKEN Co., Ltd.
Institute
Department

Funding Source
Organization METI(Japan)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor Saravio Cosmetics Ltd.
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 芝パレスクリニック (東京都)       Shiba Palace Clinic (Tokyo)
株式会社SOUKEN          SOUKEN Co. Ltd.

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 20 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 08 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 18 Day
Last follow-up date
2018 Year 01 Month 10 Day
Date of closure to data entry
2018 Year 02 Month 02 Day
Date trial data considered complete
2018 Year 02 Month 08 Day
Date analysis concluded
2018 Year 02 Month 23 Day

Other
Other related information

Management information
Registered date
2018 Year 03 Month 05 Day
Last modified on
2018 Year 03 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036055

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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