UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000048040
Receipt No. R000054753
Scientific Title A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Date of disclosure of the study information 2022/06/17
Last modified on 2022/06/13

* 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 A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Acronym A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Scientific Title:Acronym A study evaluating the effect of botanical ingredient-containing food on parameters of glucose metabolism.
Region
Japan

Condition
Condition Not applicable
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objective is to evaluate the effect of botanical ingredient-containing food on parameters of glucose metabolism after repeated intake for 12 weeks.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes HbA1c
Key secondary outcomes

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 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Subjects take control food for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_2 Subjects take test food 1 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
Interventions/Control_3 Subjects take test food 2 (containing botanical ingredient) for 12 weeks. Before and after repeated intake, subjects take blood sampling.
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) Healthy male and female subjects whose ages are 20 <= years old <65.
(2) Subjects who can visit the specified clinic on the scheduled day.
(3) Subjects who agree with the given description and express informed consent via written documents.
(4) Subjects whose HbA1c is equal to or more than 5.6 % and less than 6.5 %.
Key exclusion criteria (1) Systolic pressure <90 mmHg
(2) pregnant or lactating.
(3) donated over 200ml blood components or whole blood within the past 4 weeks.
(4) Male who donated over 400ml whole blood within the past 12 weeks.
(5) Female who donated over 400ml whole blood within the past 16 weeks.
(6) Male whose blood was collected more than 1200 mL within the last 12 months when the amount of blood sampling in the current study is added.
(7) Female whose blood was collected more than 800 mL within the last 12 months when the amount of blood sampling in the current study is added.
(8) participating in other clinical studies, or who finished clinical study within the last 4 weeks.
(9)Subjects
a) with disease on heart, liver, kidney or other organs complications.
b) with a previous history of disease on circulatory organs.
c) contracting diabetes.
d) with test food allergy.
(10) Who have possibility to be diagnosed as diabetes; whose fasting blood glucose is equal to or more than 126 mg/dL, or whose blood glucose level during the 75g OGTT is equivalent to or more than 200 mg/dL at 120 min., or whose HbA1c is equal to or more than 6.5 %.
(11) with severe allergic reaction to drug medicine and food.
(12) with a previous history of feeling sick after blood sampling.
(13) Who have difficulty in blood sampling from peripheral vein.
(14) Who drink alcohol a lot (over 60 g of alcohol per day on average).
(15) Who have irregular eating patterns.
(16) Who work irregular shifts or at midnight.
(17) constantly taking certain drug medicine, or expecting taking it within the period of current study, or indispensable supplements, functional foods (including Food for Specified Health Uses) affecting the test results.
(18) whose BMI is less than 18.5 or equal to or more than 30.0 kg/m2.
(19) contracting atopic dermatitis and/or allergy symptoms.
(20) contracting alcohol hypersensitivity.
(21) judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 135

Research contact person
Name of lead principal investigator
1st name Takanori
Middle name
Last name Teramoto
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code 619-0238
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-6114
Email Takanori_Teramoto@suntory.co.jp

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Fukizawa
Organization Suntory Global Innovation Center Ltd.
Division name Research Institute
Zip code 619-0238
Address 8-1-1 Seikadai, Seika-cho, Soraku-gun, Kyoto, Japan
TEL 050-3182-6114
Homepage URL
Email Takanori_Teramoto@suntory.co.jp

Sponsor
Institute Suntory Global Innovation Center Ltd.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committees of Yoga Allergy Clinic
Address 4-32-16, Yoga, Setagaya-ku, Tokyo, Japan
Tel 03-5491-4478
Email info@yg-allergy.com

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
2022 Year 06 Month 17 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 Preinitiation
Date of protocol fixation
2022 Year 06 Month 10 Day
Date of IRB
Anticipated trial start date
2022 Year 06 Month 25 Day
Last follow-up date
2023 Year 01 Month 16 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2022 Year 06 Month 13 Day
Last modified on
2022 Year 06 Month 13 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054753

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.