UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038037 |
|---|---|
| Receipt number | R000043364 |
| Scientific Title | The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study- |
| Date of disclosure of the study information | 2019/09/21 |
| Last modified on | 2020/03/19 10:45:24 |
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Basic information
Public title
The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study-
Acronym
The attenuating effect of HBF2019-03 on postprandial serum triglyceride level.
Scientific Title
The attenuating effect of HBF2019-03 on postprandial serum triglyceride level in healthy human subjects -A placebo controlled, randomized, double blind, cross-over study-
Scientific Title:Acronym
The attenuating effect of HBF2019-03 on postprandial serum triglyceride level.
Region
| Japan |
Condition
Condition
N/A (healthy adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of HBF2019-03 on the suppression of the elevation of postprandial serum triglyceride.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Time course of serum triglyceride level and AUC (area under the curve) (0-6hrs)
Key secondary outcomes
*Secondary outcomes
Time course of serum RLP-cholesterol level and AUC (area under the curve) (0-6hrs)
*Safety
Doctor's questions
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Placebo food (a single time intake) -> 1-week washout -> Test food, containing HBF2019-03 (a single time intake)
Interventions/Control_2
Test food, containing HBF2019-03 (a single time intake) -> 1-week washout -> Placebo food (a single time intake)
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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
[1] Healthy males and females aged 20-64 years old when informed consent.
[2] Fasting serum triglyceride level is between 120 and 200 mg/dL.
[3] Who don't large amount of alcohol habitually.
[4] Who are judged not suffering from a disease by the investigator.
[5] Individuals giving written informed consent.
Key exclusion criteria
[1] Who use medical products affecting lipid metabolism.
[2] Who can't stop using supplements which affecting lipid metabolism during the study period.
[3] Who can't abstinent from alcohol from two days before each examination.
[4] Who are allergic to placebo food and/or test food and/or the ingredient of high-fat meal.
[5] Who have a history of serious kidney damage, hepatopathy, heart disease, respiratory disease, endocrine disease, or any other metabolic disease(s) or who is under medical treatment.
[6] Who have chronic disease and is under medication.
[7] Who have digestive organ disease or surgical history affecting digestion and absorption of foods.
[8] Who are judged inappropriate for the study by the investigator in the screening.
[9] Who are diagnosed as severe anemia in screening and not suitable for frequent collection of blood.
[10] Who had an onset diarrhea within a week from the date of screening, and/or who are prone to diarrhea on a daily basis.
[11] Who with significantly different fasting serum triglycerides levels of each test day.
[12] Who have little change in serum triglyceride level after intake high-fat meal, or who continue to rise 6 hours after the meal, or who are judged abnormal changes in serum triglyceride level by the investigator in the screening.
[13] Who donated blood over 200mL in the past a month or over 400mL in the past 3 months from the date of informed consent.
[14] Who are diagnosed as familial hyperlipidemia.
[15] Who are drug addict and/or alcohol addict.
[16] Who with irregular life rhythms such as shift workers or works late at night.
[17] Who are participating in other studies that using food(s), pharmaceutical(s), and cosmetic(s) now, or who have participated or are willing to participate in other studies within a month from the date of informed consent.
[18] Who are or are possibly pregnant, or who are lactating, during the study period.
[19] Who are judged inappropriate for the study by the investigator.
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Yoshitaka |
| Middle name | |
| Last name | Iwama |
Organization
Nihonbashi Cardiology Clinic
Division name
Director
Zip code
103-0001
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
TEL
03-5641-4133
yiwama@well-sleep.jp
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
Sales department
Zip code
105-0023
Address
Shibaura-omodaka Bldg. 7F, 1-9-7, Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
Funding Source
Organization
Hayashibara CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Committee of Nihonbashi Cardiology Clinic
Address
Kyodo Bldg. #201, 13 - 4 Nihonbashi Kodenmacho, Chuo-ku, Tokyo
Tel
03-5641-4133
niho-jimucho@well-sleep.jp
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
医療法人財団健康睡眠会 日本橋循環器科クリニック（東京都）
/Nihonbashi Cardiology Clinic（Tokyo）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 21 | 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
90
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
| 2019 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 11 | Month | 10 | 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 | 09 | Month | 18 | Day |
Last modified on
| 2020 | Year | 03 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043364
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