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Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000036678
Receipt No. 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 2019/10/28

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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
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
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 36
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 No longer recruiting
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
2019 Year 10 Month 28 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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