UMIN-CTR Clinical Trial

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, active 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	Completed
Date of protocol fixation	2020 Year 07 Month 16 Day
Date of IRB	2020 Year 09 Month 10 Day
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	2021 Year 02 Month 03 Day
Date trial data considered complete	2021 Year 02 Month 09 Day
Date analysis concluded	2021 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2020 Year 08 Month 20 Day
Last modified on	2021 Year 03 Month 31 Day

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