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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014317
Receipt No. 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

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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
Email 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
Email shiken@oneness-sup.co.jp

Sponsor
Institute Oneness Support Co., Ltd.
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016667

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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