UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019967
Receipt No. R000023052
Scientific Title Study of the effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol : an open-labeled pilot study
Date of disclosure of the study information 2015/11/27
Last modified on 2017/04/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Study of the effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol : an open-labeled pilot study
Acronym The effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol.
Scientific Title Study of the effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol : an open-labeled pilot study
Scientific Title:Acronym The effects of food containing HYA on fasting blood glucose, triglyceride, LDL-cholesterol.
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the effect on fasting blood glucose, serum Triglyceride, LDL-cholesterol under the consumption of HYA for 12 weeks
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Fasting blood glucose level, Triglyceride level and LDL-cholesterol level at weeks 4, 8 and 12 ingestion
Key secondary outcomes

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of food containing HYA for 12 weeks, 1 package 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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1) Males and females from 20 to 64 years of age
(2) Subjects falling under any of the following criteria
a. Fasting blood glucose levels are ranged from 100 mg/dL to 125 mg/dL
b. Serum Triglyceride levels are ranged from 120 mg/dL to 199 mg/dL
c. LDL-Cholesterol levels are ranged from 120 mg/dL to 159 mg/dL
Key exclusion criteria (1) Subjects who routinely use health food containing large amount of fatty acids or health food for diet
(2) Subjects who constantly use oral medication and/or functional foods which may affecting serum lipid levels, lipid metabolism and/or glycometabolism
(3) Subjects who have under treatment or a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(4) Subjects having possibilities for emerging allergy related to the current study
(5) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(6) Subjects who are judged as unsuitable for the current study based on the results of clinical and physical preliminary examination
(7) Subjects who have participated in other clinical studies within the last one month prior to the current study or are planned to participate in other studies after obtaining informed consent for the current study
(8) Subjects who intend to become pregnant or lactating
(9) Subjects who are judged as unsuitable for the current study based on the results of lifestyle questionnaire
(10) Subjects judged as unsuitable for the current study by the investigator
Target sample size 40

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yasunori Yonejima
Organization NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Division name Research and Development Division
Zip code
Address 35-3, Minamibiraki., Kamiueno-cho, Muko-shi Kyoto
TEL 075-921-5344
Email y.yonejima@nitto-ph.com

Public contact
1st name of contact person
1st name
Middle name
Last name Shinsuke Tsuji
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL 03-5459-5329
Homepage URL
Email s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd
Institute
Department

Funding Source
Organization NITTO PHARMACEUTICAL INDUSTRIES Co., Ltd.
Organization
Division
Category of Funding Organization Self funding
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

Other administrative information
Date of disclosure of the study information
2015 Year 11 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Intake of HYA-containing foods suggested possibility that the effect of the improving the fasting blood glucose in subjects with high BMI and fasting blood glucose level.
There was no problem in the safety of HYA-containing foods in this test conditions.
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
2015 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2015 Year 11 Month 28 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
2015 Year 11 Month 27 Day
Last modified on
2017 Year 04 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023052

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.