UMIN-CTR Clinical Trial

Basic information
Public title	The verification study for the fasting blood glucose reduction effects
Acronym	The verification study for the fasting blood glucose reduction effects
Scientific Title	The verification for the improvement of the function of glucose metabolism and safety of the proanthocianidins derived from Acacia Bark in healthy Japanese adult subjects: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	The verification for the improvement of the function of glucose metabolism and safety of the proanthocianidins derived from Acacia Bark in healthy Japanese adult subjects
Region	Japan

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

Objectives
Narrative objectives1	To verify the suppressive effects on the elevation of postprandial blood glucose and glucose absorption with the intake of the test food. In addition, to verify the reduction effects on fasting blood glucose and the safety of long-term intake of the test food for 12 weeks.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured value of fasting blood glucose level at 12 weeks after the start of test-food consumption (12w)
Key secondary outcomes	1. The ratio of the number of subjects who are less than 110 mg/dL in fasting blood glucose level at 12w 2. The measured value of fasting blood glucose level at eight weeks after the start of test-food consumption (8w) 3. The measured value of fasting blood glucose level at four weeks after the start of test-food consumption (4w) 4. The change values of fasting blood glucose levels between at the examination before start of test-food consumption and at 4w, 8w and 12w 5. IAUC0-30, IAUC0-60, IAUC0-90, IAUC0-120 and Cmax at the examination before test-food consumption (with glucose load) 6. The measured values of blood glucose levels at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load) 7. The change values of blood glucose levels before glucose load and at 30, 60, 90 and 120 minutes after glucose load of the examination before test-food consumption (with glucose load) 8-1. The measured values of hemoglobin A1c (HbA1c: NGSP) level at 12w 8-2. The change values of hemoglobin A1c (HbA1c: NGSP) level between at the examination before start of test-food consumption and at 12w

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	YES
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Duration: 12 weeks Test food: Tablet containing proanthocianidins derived from Acacia Bark Glucose load (the examination before test-food consumption): "Sato No Gohan" (200 g; retort cooked rice) Administration: 1. During test-food consumption: Take six tablets with water without chewing before meals. * If you forget to take the test food, take it as soon as you remember within the day. 2. The examination before test-food consumption: Take six tablets with water without chewing five minutes before glucose load.
Interventions/Control_2	Duration: 12 weeks Test food: Placebo tablet Glucose load (the examination before test-food consumption): "Sato No Gohan" (200 g; retort cooked rice) Administration: 1. During test-food consumption: Take six tablets with water without chewing before meals. * If you forget to take the test food, take it as soon as you remember within the day. 2. The examination before test-food consumption: Take six tablets with water without chewing five minutes before glucose 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adult subjects 2. Subjects who have relatively high levels of blood glucose, or being anxious about or suffering their blood glucose 3. Subjects who are judged as eligible to participate in the study by the physician 4. Subjects who are between 110 mg/dL or more and 125 mg/dL or less in fasting blood glucose at screening (before test-food consumption)
Key exclusion criteria	1. Subjects who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction 2. Subjects who have a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Currently undergoing treatment for any of the following chronic disease: cardiac arrhythmia, liver disorder, kidney disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage in daily 5. Currently taking medicines (include herbal medicines) and supplements 6. Subjects who are allergic to medicines and/or the test food related products 7. Subjects who are pregnant, breast-feeding, and planning to become pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial or plan to participate another trial during this trial 9. Subjects who are judged as ineligible to participate in the study by the physician
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Kazuo Middle name Last name YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Acacia-No-Ki Co.,Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	the ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	info@takara-clinic.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	医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 06 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	66
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	2020 Year 01 Month 24 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 02 Month 10 Day
Last follow-up date	2020 Year 10 Month 19 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 06 Day
Last modified on	2021 Year 12 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044937