UMIN-CTR Clinical Trial

Basic information
Public title	Effects of consumption of the test food on postprandial blood triglyceride and glucose in healthy Japanese subjects
Acronym	Effects of consumption of the test food on postprandial blood triglyceride and glucose in healthy Japanese subjects
Scientific Title	Effects of consumption of the test food on postprandial blood triglyceride and glucose in healthy Japanese subjects: a randomized, double-blind, placebo-controlled, crossover trial
Scientific Title:Acronym	Effects of consumption of the test food on postprandial blood triglyceride and glucose in healthy Japanese 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 effects of consumption of the test food on postprandial blood triglyceride and glucose levels in healthy Japanese subjects.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Blood triglyceride level 2. Blood glucose level *1 Take blood samples before eating the test food and at 120, 180, 240, and 360 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 360 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood triglyceride levels of each measuring point. *2 Take blood samples before eating the test food and at 30, 60, 90, and 120 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 120 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood glucose levels of each measuring point.
Key secondary outcomes	1. Insulin 2. HOMA-beta 3. HOMA-R 4. remnant like particles-cholesterol *1-3 Take blood samples before eating the test food. Assess the measured values at screening (before consumption) and at 1st and 2nd periods. HOMA-beta and HOMA-R are calculated by the formulas: HOMA-beta = (blood insulin level x 360) / (fasting blood glucose level - 63) HOMA-R = blood insulin level x fasting blood glucose level / 405 *4 Take blood samples before eating the test food and at 120, 180, 240, and 360 minutes after intake. Assess the incremental area under curve (IAUC) between before eating the test food and 360 minutes after eating the test food, the maximum blood concentration (Cmax), and the blood triglyceride levels of each measuring point.

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	YES
Dynamic allocation	NO
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	Period I: Active tablets Period II: Placebo tablets * The intervention sequence is I-II, and each beverage is single ingestion. * Take 2 tablets of the test food with water and then eat the prescribed diet with water in 20 minutes. The total intake of water must be 200 mL. *Washout period is for 1 week and more.
Interventions/Control_2	Period I. Placebo tablets Period II. Active tablets * The intervention sequence is I-II, and each beverage is single ingestion. * Take 2 tablets of the test food with water and then eat the prescribed diet with water in 20 minutes. The total intake of water must be 200 mL. *Washout period is for 1 week and more.
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 are judged as eligible to participate in the study by the physician 3. Subjects who have relatively large IAUC of the blood triglyceride levels at screening (before 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 diseases: cardiac arrhythmia, liver disease, kidney disease, 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 Function Claims", or other functional food/beverage in daily. Particularly taking food/beverage effective in lowering blood sugar and anticoagulation in daily. 5. Subjects who are currently taking medications (including herbal medicines) and supplements. Particularly taking hypoglycemic agent and anticoagulants in daily. 6. Subjects who are allergic to medicines and/or the test food related products. Particularly allergic to soybeans, pork, beef, chicken, wheat, and milk. 7. Subjects who are pregnant, lactation, or 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 enroll in anther clinical trial during trial period 9. Subjects who are planning to undergo a surgical operation within two weeks from the date of finish of the intervention period 10. Subjects who are ineligibility to participate in the study based on the evaluation of the principal physician
Target sample size	34

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	0338180610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	DHC Corporation
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	2019 Year 05 Month 08 Day

Related information
URL releasing protocol	Unpublished
Publication of results	Published

Result
URL related to results and publications	http://www.pieronline.jp/content/article/0386-3603/48110/1999
Number of participants that the trial has enrolled	36
Results	Kageyama M, Tomobe H, Kobashi R, Nakashima N, Akiyoshi K, Omori R, Yamada A, Takahashi Y, Takara T. The effects of consuming a tablet supplement containing Terminalia bellirica and banaba leaf extracts on postprandial blood triglycerides and glucose in healthy Japanese subjects-a randomized, double-blind, placebo-controlled, crossover trial. Pharmacol Ther. 2020; 48(11): 1999-2009
Results date posted	2021 Year 05 Month 27 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2020 Year 11 Month 20 Day
Baseline Characteristics	Refer to the paper
Participant flow	Refer to the paper
Adverse events	Refer to the paper
Outcome measures	Refer to the paper
Plan to share IPD	Undecided
IPD sharing Plan description	To require consultation among related companies

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 04 Month 16 Day
Date of IRB	2019 Year 04 Month 16 Day
Anticipated trial start date	2019 Year 05 Month 09 Day
Last follow-up date	2019 Year 10 Month 18 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 08 Day
Last modified on	2021 Year 05 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041703