UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045061
Receipt number R000051368
Scientific Title A randomized, double blind, placebo-controlled, parallel study to investigate the inhibitory effect of purple sweet potato beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.
Date of disclosure of the study information 2021/08/11
Last modified on 2023/03/31 14:11:38

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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 beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.

Acronym

Clinical trial to investigate the inhibitory effect of purple sweet potato beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.

Scientific Title

A randomized, double blind, placebo-controlled, parallel study to investigate the inhibitory effect of purple sweet potato beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.

Scientific Title:Acronym

Clinical trial to investigate the inhibitory effect of purple sweet potato beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.

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 beverage on postprandial blood glucose elevation in healthy adults who have high postprandial blood glucose level.

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 GLP-1 and GIP levels in blood at 30min, 60min, 90min and 120 minutes after meal lord.
5. The incremental area under the curve of the postprandial GLP-1 and GIP levels in blood. The maximum levels of the postprandial GLP-1 and GIP in blood.
6. 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 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 don't have abnormal blood glucose level at the time of screening test (fasting blood glucose level of 126mg/dL or higher, blood glucose level of 200mg/dL or higher at 120 minutes after meal load, or HbA1c(NGSP) of 6.5% or higher).
3. Subjects whose blood glucose level of 30 minutes after meal load at the time of screening test is 140mg/dL or higher and lower than 200mg/dL.
4. Subjects who have no clinical abnormality by screening tests.
5. 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 a history of laparotomy or ileus.
2. Subjects who have chronic bowel disease with digestive and absorption disorders.
3. Subjects who have respiratory, gastrointestinal, hepatic/gallbladder/pancreatic, hematologic, renal, endocrine, cardiovascular and/or mental disease, or who have history of those diseases.
4. Subjects who had a serious injury or surgical history within 12 weeks prior to this study.
5. Pre- or post-menopausal women having obvious changes in physical condition.
6. 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.
7. 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.
8. Subjects who regularly take drugs, foods for specified health uses, foods with function claims and/or supplements, etc. which would affect this study.
9. Subjects donate either 400ml or 200ml whole blood or blood component within four weeks prior to this study.
10. Subjects who are pregnant or lactating, or subjects who expect to be pregnant during this study.
11. Subjects who have cognitive disorder or who have possibility of the disorder.
12. Subjects who participated and took the study drug in other clinical trials within four weeks prior to this study.
13. Subjects who are judges as unsuitable for this study by the principal investigator or subinvestigators.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Yasuji
Middle name
Last name Arimura

Organization

University of Miyazaki

Division name

Department of Food & Health Research, 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

Dept. of Food & Health Research, 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 or person

Institute

University of Miyazaki

Institute

Department

Personal name



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

2021 Year 08 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

2021 Year 07 Month 06 Day

Date of IRB

2021 Year 08 Month 03 Day

Anticipated trial start date

2021 Year 08 Month 10 Day

Last follow-up date

2022 Year 06 Month 02 Day

Date of closure to data entry

2022 Year 08 Month 10 Day

Date trial data considered complete

2022 Year 08 Month 31 Day

Date analysis concluded

2023 Year 01 Month 16 Day


Other

Other related information



Management information

Registered date

2021 Year 08 Month 04 Day

Last modified on

2023 Year 03 Month 31 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051368


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name