UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014317 |
|---|---|
| Receipt number | R000016667 |
| Scientific Title | Effects of ingestion of a food on glycometabolism A randomized, double blind, placebo-controlled study |
| Date of disclosure of the study information | 2014/06/19 |
| Last modified on | 2018/07/13 15:58:08 |
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Basic information
Public title
Effects of ingestion of a food on glycometabolism
A randomized, double blind, placebo-controlled study
Acronym
Effects of ingestion of a food on glycometabolism
Scientific Title
Effects of ingestion of a food on glycometabolism
A randomized, double blind, placebo-controlled study
Scientific Title:Acronym
Effects of ingestion of a food on glycometabolism
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to evaluate the effects of ingestion of a food on glycometabolism for japanese male and female between the ages of 20 years and 59 years.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
P1asma glucose, 2-hr PG, Insulin, TG, Glico albumin, Insulinogenic index, HOMA-IR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of food for 12 consecutive weeks
Interventions/Control_2
Ingestion of placebo for 12 consecutive 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1)Japanese male and female aged between 20 and 59 years
(2)Subjects who have blood sugar level between 140 and 199mg/dL at 120 minutes after 75g glucose load by OGTT and high levels of fasting blood sugar and triglyceride. The investigator judge whether subjects who have blood sugar level of between 200 and 210mg/dL are included in this study or not.
Key exclusion criteria
(1)Subjects who are treating diabetes or dyslipidemia
(2)Subjects who have a serious disease or health history
(3)Subjects who have disability of the functions of the heart and the lungs
(4)Subjects who were operated on the alimentary canal
(5)Subjects who are treating illness at present
(6)Subjects with food and medicine allergies
(7)Subjects who take vigorous exercise or are on a diet
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
Higashi-Tenma Building 8F, 1-7-17, Higashi Tenma, Kita-ku, Osaka
TEL
0648018917
mterashima@oneness-sup.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Terashima |
Organization
Oneness Support Co., Ltd.
Division name
Clinical trial Division
Zip code
Address
Higashi-Tenma Building 8F, 1-7-17, Higashi Tenma, Kita-ku, Osaka
TEL
0648018917
Homepage URL
shiken@oneness-sup.co.jp
Sponsor or person
Institute
Oneness Support Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
FUJI OIL 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
みうらクリニック（大阪府）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 19 | 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
| 2014 | Year | 04 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 23 | 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
| 2014 | Year | 06 | Month | 19 | Day |
Last modified on
| 2018 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016667
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
