UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031585 |
|---|---|
| Receipt number | 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 14:23:17 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
SOUKEN Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036055
