UMIN-CTR Clinical Trial

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
Institute	Nishikyushu University
Institute
Department

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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000051815