UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055353 |
|---|---|
| Receipt number | R000055647 |
| Scientific Title | Effect of Mulberry Lingzhi tea on the inhibition of elevated blood glucose and its safety: Randomized, double-blind, placebo-controlled, crossover comparative study |
| Date of disclosure of the study information | 2024/08/28 |
| Last modified on | 2024/08/28 16:29:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Mulberry Lingzhi tea on the inhibition of elevated blood glucose and its safety: a short-term ingestion study
Acronym
Short-term ingestion study of Mulberry Lingzhi tea
Scientific Title
Effect of Mulberry Lingzhi tea on the inhibition of elevated blood glucose and its safety: Randomized, double-blind, placebo-controlled, crossover comparative study
Scientific Title:Acronym
Short-term intake study of Mulberry Lingzhi Tea
Region
| Japan |
Condition
Condition
Impaired glucose tolerance
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluating the effect of short-term drinking of Mulberry Lingzhi tea on the suppression of elevated blood glucose.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial blood glucose level during the treatment period
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Mulberry Lingzhi tea before meals
Interventions/Control_2
Before every meal for 2 weeks
Interventions/Control_3
Continuous measurement using an extracorporeal continuous blood glucose meter
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
| 40 | years-old | <= |
Age-upper limit
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Fasting blood glucose level of at least 110 mg/dL but less than 126 mg/dL
or hemoglobin A1c level is between 6.1% and 6.5%.
Key exclusion criteria
(1) Those whose blood glucose and hemoglobin A1c levels correspond to diabetes (fasting blood glucose level of 126 mg/dL or higher, hemoglobin A1c of 6.5% or higher)
(2) Patients who are on continuous treatment with medication
(3) Consuming medicines, foods for specified health use, functional foods, or health foods that may affect the results of the study.
(4) Persons with a history of serious diseases of the heart, liver, kidney, digestive organs, etc.
(5) Those with anemia (hemoglobin level of 12.5 g/dl or less for men and 11.5 g/dl or less for women)
(6) Those who consume excessive amounts of alcohol (more than 60 g of pure alcohol, which is 3 times the appropriate amount, e.g., more than 1.5 L of beer or more than 3 g of sake).
(7) Shift workers, late-night workers, and others with an irregular rhythm of life.
(8) Persons who are allergic to medicines or food
(9) Pre-menopausal women
(10) Persons with implanted pacemakers
(11) Other subjects deemed unsuitable by the investigator.
(12) Subjects who have requested discontinuation of the study (excluded at any time upon receipt of a written withdrawal of consent).
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Hara |
Organization
Saga University
Division name
Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1
TEL
0952342289
harameg@cc.saga-u.ac.jp
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Hara |
Organization
Saga University
Division name
Medicine
Zip code
849-8501
Address
Nabeshima 5-1-1
TEL
0952342289
Homepage URL
harameg@cc.saga-u.ac.jp
Sponsor or person
Institute
Saga University
Institute
Department
Personal name
Funding Source
Organization
Kanzaki City
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanzaki city
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saga University
Address
Nabeshima5-1-1, Saga
Tel
0952342289
harameg@cc.saga-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
神埼市役所（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 08 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
31
Results
The Kuwahishi tea group showed less fluctuation in blood glucose levels. There was no significant difference in the incidence of hypoglycemia among the beverages.
Results date posted
| 2024 | Year | 08 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 03 | Month | 31 | Day |
Baseline Characteristics
31 subjects whose blood glucose and hemoglobin A1c did not correspond to diabetes (<126mg/dL, <6.5%) but were concerned about their blood glucose levels
Participant flow
Citizens were invited to apply to participate.
Adverse events
No adverse events of note
Outcome measures
Inhibition of postprandial blood glucose elevation
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2022 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2022 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2024 | Year | 08 | Month | 28 | Day |
Last modified on
| 2024 | Year | 08 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055647
