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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041490
Receipt No. R000047307
Scientific Title A randomized, double blind, placebo-controlled, parallel study to investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Date of disclosure of the study information 2020/09/11
Last modified on 2020/09/01

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Basic information
Public title A randomized, double blind, placebo-controlled, parallel study to investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Acronym Clinical trial to investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Scientific Title A randomized, double blind, placebo-controlled, parallel study to investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Scientific Title:Acronym Clinical trial to investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Region
Japan

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

Objectives
Narrative objectives1 To investigate the inhibitory effect of purple sweet potato concentrated beverage on postprandial blood glucose elevation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes The blood glucose level at 30 minutes after meal lord.
Key secondary outcomes 1. The actual values (excluding 30min after a meal) and the changes of blood glucose level at 30min, 60min, 90min and 120 minutes after food ingestion.
2. The actual values and the changes of blood insulin level at 30min, 60min, 90min and 120 minutes after meal lord.
3. The incremental area under the curve of the postprandial blood glucose and insulin. The maximum levels of the postprandial blood glucose and insulin.
4. The actual values and the changes of triglyceride and free fatty acid at each evaluation point after meal lord.
5. The incremental area under the curve and the maximum level of triglyceride and free fatty acid.
6.The actual values and the change of blood test index related to glycolipid metabolism at each evaluation point except above mentioned (RLP-C, ApoB48, active GLP-1, GIP).
7. Adverse events.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 The subjects take 125 ml of purple sweet potato concentrated beverage before meal load.
Interventions/Control_2 The subjects take 125 ml of placebo beverage before meal load.
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
60 years-old >=
Gender Male and Female
Key inclusion criteria 1. Subjects who are judged as healthy by self-reported health questionnaire.
2. Subjects who have no clinical abnormality by screening tests.
3. Subjects who agree to participate in this study with a written informed consent after receiving sufficient explanation relating to this study.
Key exclusion criteria 1. Subjects who have diabetic type blood abnormality at the time of screening test (fasting glucose level of 126mg/dL or more, casual glucose level of 200mg/dL or more, or HbA1c(NGSP) of 6.5% or more).
2. Subjects who have a history of laparotomy or ileus.
3. Subjects who have chronic bowel disease with digestive and absorption disorders.
4. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine,
cardiovascular and/or mental disease, or
who have history of those diseases.
5. Subjects who had a serious injury or surgical history within 12 weeks prior to this study.
6. Pre-or post-menopausal women having obvious changes in physical condition.
7. Subjects who have history of allergic reaction to foods (especially potatoes, sesame, etc.) or drugs which needs its treatment or who have possibility of the reaction.
8. Heavy smokers (more than 21 cigarettes per day), alcohol addicts (more than 80g per day alcohol), subjects who are alcohol or drug dependence, subjects who are suspected of alcohol or drug dependence.
9. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
10. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study.
11. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
12. Subjects who have cognitive disorder or who have possibility of the disorder.
13. Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study.
14. Subjects who are judges as unsuitable for this study by the principal invesetigator or subinvestigators.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Yasuji
Middle name
Last name Arimura
Organization University of Miyazaki
Division name Clinical research support center, University of Miyazaki hospital
Zip code 889-1692
Address Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL 0985-85-9577
Email yasuji_arimura@med.miyazaki-u.ac.jp

Public contact
Name of contact person
1st name Yasuji
Middle name
Last name Arimura
Organization University of Miyazaki
Division name Clinical research support center, University of Miyazaki hospital
Zip code 889-1692
Address Kihara5200,Kiyotake,Miyazaki889-1692,Japan
TEL 0985-85-9577
Homepage URL
Email yasuji_arimura@med.miyazaki-u.ac.jp

Sponsor
Institute University of Miyazaki
Institute
Department

Funding Source
Organization Miyazaki Prefecture
Organization
Division
Category of Funding Organization Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Research Ethics Committee of University of Miyazaki
Address Kihara 5200, Kiyotake, Miyazaki 889-1692, Japan
Tel 0985-85-9010
Email igakubu_kenkyu@med.miyazaki-u.ac.jp

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 宮崎大学医学部附属病院(宮崎県)University of Miyazaki hospital:Miyazaki prefecture

Other administrative information
Date of disclosure of the study information
2020 Year 09 Month 11 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 Preinitiation
Date of protocol fixation
2020 Year 07 Month 16 Day
Date of IRB
Anticipated trial start date
2020 Year 09 Month 11 Day
Last follow-up date
2020 Year 12 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 20 Day
Last modified on
2020 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047307

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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