UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000045377
Receipt number R000051815
Scientific Title Effect of mulberry leaves and water chestnut tea intake on blood sugar elevation
Date of disclosure of the study information 2021/09/04
Last modified on 2022/09/05 12:25:52

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Basic information

Public title

Effect of mulberry leaves and water chestnut tea intake on blood sugar elevation

Acronym

Effect of mulberry leaves and water chestnut tea intake on blood sugar elevation

Scientific Title

Effect of mulberry leaves and water chestnut tea intake on blood sugar elevation

Scientific Title:Acronym

Effect of mulberry leaves and water chestnut tea intake on blood sugar elevation

Region

Japan


Condition

Condition

Postprandial huperglycemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To investigate the effect of mulberry leaves and water chestnut on postprandial hyperglycemia

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Postprandial blood glucose level

Key secondary outcomes

Blood insulin concentration


Base

Study type

Interventional


Study design

Basic design

Cross-over

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

Prevention

Type of intervention

Food

Interventions/Control_1

The subjects ingested a single intake of the active meal, and ingested a single intake of the placebo meal after 7 days or 14 days.

Interventions/Control_2

The subjects ingested a single intake of the active meal, and ingested a single intake of the placebo meal after 7 days or 14 days.

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

65 years-old >=

Gender

Male and Female

Key inclusion criteria

1) Male and female between 20 and 65 years old
2) Those with high blood sugar levels or hemoglobin A1c at the time of screening test
3) Individuals who understand the purpose and contents of the experiment

Key exclusion criteria

1. 1. Those who do not meet the selection criteria
2. Those who are undergoing continuous treatment with drugs
3. 3. Those who regularly eat medicines, foods for specified health use, foods with functional claims, and health foods that may affect the test results
4. Those who have a history of serious illnesses such as heart, liver, kidneys, digestive system, etc.
5. Those who consume excessive alcohol
6. Those who have irregular life rhythms such as shift work and late night work
7. Those who are allergic to medicines and food
8. Those who are pregnant or may be pregnant
9. Those who are breastfeeding
10. In addition, those who the investigator judges to be inappropriate as a subject
11. Those who have a request to cancel from the research subject

Target sample size

35


Research contact person

Name of lead principal investigator

1st name Midori
Middle name
Last name Yasuda

Organization

Nishikyushu University

Division name

Faculty of Health and Nutrition Sciences

Zip code

842-8585

Address

4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga

TEL

0952-52-4191

Email

midori@nisikyu-u.ac.jp


Public contact

Name of contact person

1st name Midori
Middle name
Last name Yasuda

Organization

Nishikyushu University

Division name

Faculty of Health and Nutrition Sciences

Zip code

842-8585

Address

4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga

TEL

0952-52-4191

Homepage URL


Email

midori@nisikyu-u.ac.jp


Sponsor or person

Institute

Nishikyushu University

Institute

Department

Personal name



Funding Source

Organization

Kanzaki-shi

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

Nishikyushu University

Address

4490-9 Osaki, Kanzaki-machi, Kanzaki-shi, Saga, Japan

Tel

0952-52-4191

Email

midori@nisikyu-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



Other administrative information

Date of disclosure of the study information

2021 Year 09 Month 04 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

35

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 16 Day

Date of IRB

2021 Year 07 Month 26 Day

Anticipated trial start date

2021 Year 09 Month 03 Day

Last follow-up date

2022 Year 03 Month 31 Day

Date of closure to data entry

2022 Year 07 Month 31 Day

Date trial data considered complete

2022 Year 08 Month 19 Day

Date analysis concluded

2022 Year 09 Month 02 Day


Other

Other related information



Management information

Registered date

2021 Year 09 Month 04 Day

Last modified on

2022 Year 09 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051815


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name