UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036678 |
|---|---|
| Receipt number | R000041703 |
| 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 |
| Date of disclosure of the study information | 2019/05/08 |
| Last modified on | 2021/05/27 11:06:29 |
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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
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
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041703
